Compositions and methods for treating short bowel syndrome (SBS) with apraglutide

Abstract

The present disclosure relates to methods of treating short bowel syndrome (SBS) using apraglutide or a pharmaceutically acceptable salt thereof, and related pharmaceutical compositions and kits.

Description

VECT-007 / 001 WO (43765-02067)COMPOSITIONS AND METHODS FOR TREATING SHORT BOWEL SYNDROME (SBS) WITH APRAGLUTIDERELATED APPLICATIONS

[0001] This application claims the benefit of and priority to U. S. Provisional Application No. 63 / 765,003, filed February 28, 2025, and U.S. Provisional Application No. 63 / 990,827, filed February 25, 2026, the contents of each of which are incorporated herein by reference in their entireties.REFERENCE TO AN ELECTRONIC SEQUENCE LISTING

[0002] The contents of the electronic sequence listing (VECT-007-001WO-SeqListST26.xml; Size: 3,769 bytes; and Date of Creation: February 26, 2026) are herein incorporated by reference in their entirety.BACKGROUND

[0003] Short bowel syndrome is a malabsorptive condition characterized by extreme reduction in functional intestinal length most commonly because of surgical resection due to mesenteric ischemia or Inflammatory Bowel Disease (IBD) although other etiologies are also present. SBS with intestinal failure (SBS-IF) is defined as the reduction of gut function below the minimum necessary for the absorption of macronutrients and / or fluids and electrolytes, such that intravenous supplementation is required to maintain health and / or growth. In patients with SBS-IF parenteral support (PS) delivered through a central venous catheter is needed to maintain an adequate fluid, energy, electrolytes, trace elements, vitamins, and nutrient balance. There is spectrum of SBS-IF patients from those with stoma and no colon-in-continuity (CIC) requiring large PS volumes to those with CIC which require lower PS volumes. Because of this spectrum, decreased dependency on PS can be demonstrated in a variety of outcomes depending on anatomy, including PS volume reduction, days off PS, or achieving enteral autonomy. After surgical resection, the remaining intestine goes through a process called intestinal adaptation by which it increases its absorptive capacity to compensate for its reduced length. It has been demonstrated that intestinal adaptation can be enhanced by administering glucagon-like peptide 2 (GLP-2) or more stable analogues with extended half-lives such as teduglutide and apraglutide. Because of the physiological role of the colon, patients with CIC can manage fluid balance much better than patients with no functional colon and have lower parenteral support volumes at baseline compared with stoma patients, PS is defined as any intravenous infusion that contains fluids and electrolytes and may or may not include parenteralVECT-007 / 001WO (43765-02067)nutrition (PN). Parenteral nutrition is defined as PS that includes protein, carbohydrate, fat, vitamins and / or trace elements. Patients with chronic intestinal failure due to benign disease have a high probability of long-term survival on PS; however, extensive PS treatment (multiple days per week) can cause significant inconvenience and patient hardship, decreasing quality of life.

[0004] There is a need for improved treatment of SBS, e.g., to ameliorate symptoms such as dependency on PS, at a dosing regimen that will facilitate patient compliance. The present disclosure addresses such need.SUMMARY

[0005] In some aspects, the present disclosure provides a pharmaceutical composition comprising:(a) apraglutide in an amount of about 8 % to about 25 % by weight of total solids; (b) a buffering agent in an amount of about 0.75 % to about 4.25 % by weight; (c) a stabilizing agent in an amount of about 2.55 % to about 7.65 % by weight; and (d) a bulking agent in an amount of about 63.15 % to about 88.65 % by weight.

[0006] In some aspects, the present disclosure provides a pharmaceutical composition comprising:(a) apraglutide in an amount of about 15.5% to about 17.5% by weight of total solids;(b) glycine in an amount of about 1.25% to about 3.75% by weight of total solids;(c) L-histidine in an amount of about 2.55% to about 7.65% by weight of total solids; and (d) mannitol in an amount of about 63.15% to about 88.65% by weight of total solids.

[0007] In some aspects, the present disclosure provides a pharmaceutical composition comprising: (a) apraglutide in an amount of about 15.5% to about 17.5% by weight of total solids; (b) a buffering agent in an amount of about 1.25% to about 3.75% by weight of total solids; (c) a stabilizing agent in an amount of about 2.55% to about 7.65% by weight of total solids; (d) a bulking agent in an amount of about 63.15% to about 88.65% by weight of total solids.

[0008] In some aspects, the present disclosure provides a pharmaceutical composition comprising: (a) apraglutide in an amount of about 0.4 mol% to about 1.4 mol%; (b) a buffering agent in an amount of about 3.4 mol% to about 10.2 mol%; (c) a stabilizing agent in an amount of about 3.4 mol% to about 10.2 mol%; (d) a bulking agent in an amount of about 78.0 mol% to about 93.2 mol%.

[0009] In some aspects, the present disclosure provides a pharmaceutical compositionVECT-007 / 001WO (43765-02067)comprising: (a) apraglutide in an amount of about 0.4 mol% to about 1.4 mol%; (b) glycine in an amount of about 3.4mol% to about 10.2 mol%; (c) L-histidine in an amount of about 3.4mol% to about 10.2 mol%; (d) mannitol in an amount of about 78.0 mol% to about 93.2 mol%.

[0010] In some aspects, the present disclosure provides a pharmaceutical composition comprising: a vial load of about 5.4 mg per vial or about 10.4 mg per vial of apraglutide or a pharmaceutically acceptable salt thereof; glycine; L-histidine; and mannitol, and wherein the pharmaceutical composition is reconstituted with an effective added reconstitution volume ranging from about 0.24 mL to about 1.14 mL to provide an apraglutide concentration ranging from about 8.8 mg / mL to about 20.6 mg / mL.

[0011] In some aspects, the present disclosure provides a composition comprising: a sodium salt of apraglutide, glycine; L-histidine; and mannitol,wherein glycine, L-histidine and mannitol are in a w / w ratio (as measured to the corresponding weight of the free acid of apraglutide) as follows:glycine, present at a w / w ratio of about 0.15:1;L-histidine, present at a w / w ratio of about 0.31:1, andmannitol, present at a w / w ratio of about 4.6: 1,

[0012] In some aspects, the present disclosure provides a pharmaceutical composition comprising apraglutide or a pharmaceutically acceptable salt thereof, wherein the pharmaceutical composition is characterized by: a vial load selected from about 5.4 mg per vial or about 10.4 mg per vial; an effective added reconstitution volume selected from the range of about 0.23 mL to about 1.14 mL; an apraglutide concentration selected from the range of about 8.8 mg / mL to about 20.6 mg / mL; and an injection volume selected from the range of about 0.1 mL to about 0.85 ml,, wherein the combination of the vial load, effective added reconstitution volume, the concentration of apraglutide in the drug product, and injection volume provides an administered dose from about 2.0 mg to about 7.5 mg.

[0013] In some aspects, the present disclosure provides a pharmaceutical composition for treating short bowel syndrome in a subject, the composition comprising: a vial load of about 5.4 mg per vial of apraglutide or a pharmaceutically acceptable salt thereof; glycine; L-histidine; and mannitol, wherein the pharmaceutical composition is reconstituted with an effective added reconstitution volume of about 0,59 mL, and wherein an injection volume of about 0.40 mL provides an administered dose of about 3.5 mg with an apraglutide concentration of about 8.8 mg / mL.

[0014] In some aspects, the present disclosure provides a pharmaceutical composition forVECT-007 / 001WO (43765-02067)treating short bowel syndrome in a subject, the composition comprising: a vial load of about 10.4 mg per vial of apraglutide or a pharmaceutically acceptable salt thereof; glycine; L-histidine; and mannitol, wherein the pharmaceutical composition is reconstituted with an effective added reconstitution volume of about 1.14 mL, and wherein an injection volume of about 0.40 mL provides an administered dose of about 3.5 mg at an apraglutide concentration of about 8,8 mg / mL.

[0015] In some aspects, the present disclosure provides a pharmaceutical composition for treating short bowel syndrome in a subject, the composition comprising: a vial load of about 5.4 mg per vial of apraglutide or a pharmaceutically acceptable salt thereof; glycine; L-histidine; and mannitol, wherein the pharmaceutical composition is reconstituted with an effective added reconstitution volume of about 0.24 mL, and wherein an injection volume of about 0.17 mL provides an administered dose of about 3.5 mg at an apraglutide concentration of about 20.6 mg / mL.

[0016] In some aspects, the present disclosure provides a pharmaceutical composition for treating short bowel syndrome, the composition comprising: a vial load of about 5.4 mg per vial or about 10.4 mg per vial of apraglutide or a pharmaceutically acceptable salt thereof; glycine; L-histidine; and mannitol, wherein the pharmaceutical composition is reconstituted to provide an administered dose from about 4.0 mg to about 7.5 mg.

[0017] In some aspects, the present disclosure provides a method of preparing a pharmaceutical composition for treating short bowel syndrome in a subject, the method comprising:providing a vial containing a lyophilized powder comprising apraglutide or a pharmaceutically acceptable salt thereof, glycine, L-histidine, and mannitol;adding sterile water for injection to the vial in an effective added reconstitution volume ranging from about 0.23 mL to about 1.14 mL;admixing to form a reconstituted solution having an apraglutide concentration from about 8.8 mg / mL to about 20.6 mg / mL; andwithdrawing an injection volume from about 0.1 mL to about 0.85 mL to provide an administered dose from about 2.0 mg to about 7.5 mg.

[0018] In some aspects, the present disclosure provides a composition of any one of Tables 1A-1, 1A-2, IB, 1C, ID, IE, IF, or 1G.

[0019] In some aspects, the present disclosure provides a composition of Table 1 A-l.

[0020] In some aspects, the present disclosure provides a composition of Table 1 A-2.

[0021] In some aspects, the present disclosure provides a method of administering a composition of the present disclosure.VECT-007 / 001WO (43765-02067)

[0022] In some aspects, the present disclosure provides a method of treating short bowel syndrome (SBS) in a subject, the method comprising administering a pharmaceutical composition of the present disclosure to the subject once weekly.|0023] In some aspects, the present disclosure provides a method of treating short bowel syndrome (SBS) in a subject, the method comprising administering apraglutide, or a pharmaceutically acceptable salt thereof, to the subject once weekly, wherein:the subject has a body weight of 50 kg or greater, and the apraglutide or the pharmaceutically acceptable salt thereof is administered at a dose of about 3.5 mg; or the subject has a body weight less than 50 kg, and the apraglutide or the pharmaceutically acceptable salt thereof is administered at a dose of about 2.2 mg.|0024] In some aspects, the present disclosure provides a kit comprising: a vial containing a composition of the present disclosure; and a container of sterile water for injection.

[0025] In some aspects, the present disclosure provides a kit comprising: a vial containing a composition of the present disclosure, wherein the composition is a lyophilized powder; and a container of sterile water for injection.

[0026] In some aspects, the present disclosure provides a kit comprising: a lyophilized powder comprising a sodium salt of apraglutide, glycine, L-histidine, and mannitol, and sterile water,

[0027] In some aspects, the present disclosure provides a vial comprising a composition of the present disclosure.

[0028] In some aspects, the present disclosure provides a vial comprising a lyophilized powder, comprising:a) a sodium salt of apraglutide, wherein the corresponding weight of the free acid of apraglutide is about 5.2 mg;about 0.78 mg of glycine,about 1.61 mg of L-histidine, andabout 23.92 mg of mannitol, orb) a sodium salt of apraglutide, wherein the corresponding weight of the free acid of apraglutide is about 10.4 mg,about 1.56 mg of glycine,about 3.22 mg of L-histidine, andabout 47.84 mg of mannitol.BRIEF DESCRIPTION OF THE DRAWINGS

[0029] FIG. 1A and FIG. IB are line graphs depicting stability of the sodium salt ofVECT-007 / 001WO (43765-02067)apraglutide over 28 days in solution at a range of pH values. Stability was quantified by percent purity as a function of pH and time (FIG. 1A) and percent apraglutide dimer present as a function of pH and time (FIG. IB).|0030] FIGs. 2A-2D provide results for reduction of parenteral support (PS) for subjects administered apraglutide or placebo. FIG. 2A are line graphs for all study subjects depicting the relative change (as a percentage) from baseline weekly PS volume to weekly PS volume at 24-weeks of treatment, with corresponding percentages provided in FIG. 2B. FIG. 2C depicts results for Stoma subjects only; FIG. 2D depicts results for colon-in-continuity (CIC) subjects only.

[0031] FIG. 3A and FIG. 3B are bar graphs depicting enteral autonomy (no PS) for study subjects at 24-weeks of treatment. FIG. 3A depicts results for CIC subjects only; FIG. 3B depicts results for all subjects.

[0032] FIG.4 is a schematic diagram illustrating the study design of a randomized, open-label, single dose, two-period, two-sequence, cross-over study to investigate the relative bioavailability of apraglutide following subcutaneous administration in healthy participants.

[0033] FIG. 5 depicts plasma concentrations of apraglutide (ng / mL). Reference: a single SC dose of 3,5 mg apraglutide at a concentration of 20.6 mg / mL, corresponding to an injection volume of 0.2 mL (effective injected volume of 0.17 mL), Test: a single SC dose of 3.5 mg apraglutide at a concentration of 8.8 mg / mL, corresponding to an injection volume of 0.4 mL. BLQ = Below the limit of quantification; CV = Coefficient of variation; N = Number of participants; n = Number of non-missing observations; PKCS = PK Concentration Set; SD = Standard deviation.

[0034] FIG. 6 provides a summary of plasma pharmacokinetic parameters of apraglutide. Reference: a single SC dose of 3.5 mg apraglutide at a concentration of 20.6 mg / mL, corresponding to an injection volume of 0.2 mL (effective injected volume of 0.17 mL), Test: a single SC dose of 3.5 mg apraglutide at a concentration of 8.8 mg / mL, corresponding to an injection volume of 0.4 ml... CV = Coefficient of variation; N = Number of participants; n = Number of non-missing observations; PKCS = PK Concentration Set; SD = Standard deviation.

[0035] FIG. 7 depicts statistical assessment of relative bioavailability of apraglutide. Reference: a single SC dose of 3.5 mg apraglutide at a concentration of 20.6 mg / mL, corresponding to an injection volume of 0.2 mL (effective injected volume of 0.17 ml.), Test: a single SC dose of 3.5 mg apraglutide at a concentration of 8.8 mg / mL, corresponding to an injection volume of 0.4 mL. Ratios of geometric LS Means are presented as percentages. CI = Confidence interval; CV = Coefficient of variation; LS = Least squares; N = Number ofVECT-007 / 001WO (43765-02067)participants; n = Number of non-missing observations; PKPS = PK Parameter Set.

[0036] FIG. 8 depicts a summary of adverse events. Reference: a single SC dose of 3.5 mg apraglutide at a concentration of 20.6 mg / mL, corresponding to an injection volume of 0.2 mL (effective injected volume of 0.17 mL), Test: a single SC dose of 3.5 mg apraglutide at a concentration of 8.8 mg / mL, corresponding to an injection volume of 0.4 mL.DETAILED DESCRIPTION

[0037] The present disclosure provides GLP-2 agonists, e.g., apraglutide, and uses thereof. Apraglutide is a 33 amino acid synthetic peptide analogue of GLP-2 that acts as a selective, full agonist of the GLP-2 receptor with potency and selectivity comparable to native GLP-2 Apraglutide contains natural human as well as non-proteinogenic amino acids. The following amino acid substitutions relative to native GLP-2 were made to improve PK / PD properties: alanine (2) to glycine, methionine (10) to norleucine, asparagine (11) to D-phenylalanine, and asparagine (16) to leucine. Additionally, the carboxyl group in aspartic acid (33) is substituted by an amide group.

[0038] The amino acid sequence of GLP-2 is set forth in SEQ ID NO: 1 below, lire amino acid sequence of apraglutide is set forth in SEQ ID NO: 2 below, with the aforementioned substitutions indicated in bold:SEQ ID NO: 1 (GLP-2) His-Ala-Asp-Gly-Ser-Phe-Ser-Asp-Glu-Met-Asn-Thr-Ile-Leu-Asp-Asn-Leu-Ala-Ala-Arg-Asp-Phe-Ile-Asn-Trp-Leu-Ile-Gln-Thr-Lys-Ile-Thr-Asp-OH SEQ ID NO: 2 (Apraglutide) His-Gly-Asp-Gly-Ser-Phe-Ser-Asp-Glu-Nle-D-Phe-Thr-Ile-Leu-Asp-Leu-Leu-Ala-Ala-Arg-Asp-Phe-Ile-Asn-Trp-Leu-Ile-Gln-Thr-Lys-Ile-Thr-Asp-NH2

[0039] Without wishing to be bound by theory, it is believed that apraglutide promotes intestinal adaptation and improves absorptive capacity by delaying an accelerated gastric emptying, decreasing gastrointestinal hypersecretion, promoting intestinal growth, enhancing intestinal barrier function. Apraglutide augments activity and expression of nutrient transporters, enhances expression of digestive enzymes, and increases mesenteric blood flow.

[0040] Methods of preparing apraglutide have been described in the art and include solid phase peptide synthesis methods. For example, US 8,580,918 discloses the acetate salt of apraglutide, and US 2022 / 0000985 discloses the sodium salt of apraglutide and method of manufacturing the same.VECT-007 / 001WO (43765-02067)

[0041] In some embodiments, apraglutide is of the following chemical structure:NH2(SEQ ID NO: 2).

[0042] In some embodiments, apraglutide, or a pharmaceutically acceptable salt thereof, e.g., the sodium salt thereof, has a purity of no less than 90.0%, no less than 91.0%, no less than 92.0%, no less than 93,0%, no less than 94.0%, no less than 95,0%, no less than 96.0%, no less than 97.0%, no less than 98.0%, no less than 99.0%, no less than 99.5%, no less than 99.6%, no less than 99.7%, no less than 99.8%, or no less than 99.9%.

[0043] In some embodiments, apraglutide, or a pharmaceutically acceptable salt thereof, e.g., the sodium salt thereof, has a purity of no less than 94.0%.

[0044] In some embodiments, apraglutide, or a pharmaceutically acceptable salt thereof, e.g., the sodium salt thereof, has a purity of no less than 95.0%.

[0045] In some embodiments, apraglutide, or a pharmaceutically acceptable salt thereof, e.g., the sodium salt thereof, has a purity of no less than 97.0%.

[0046] Without wishing to be bound by theory, it is understood that apraglutide impurities may include, without limitation, Des-Gly4, Aspartimide3, Asp33-OH, Des-Ser7, D-Asp3, P-Asp3, and / or D-His1. Apraglutide impurities may further include other unspecified impurities.

[0047] In some embodiments, the amount and / or presence of Des-Gly4, Aspartimide3, Asp33- OH, Des-Ser7, D-Asp3, -Asp3, and D-His1, in a sample containing apraglutide are determined using reverse phase high performance liquid chromatography (RP-HPLC) and are expressed as a percent area of the impurity’ peak compared to total area of peptide peaks in aVECT-007 / 001WO (43765-02067)chromatographic sample. In some embodiments, the Des-Gly4and Aspartimide3cannot be separated and are detected in a single peak of the RP-HPLC chromatogram.

[0048] In some embodiments, apraglutide, or a pharmaceutically acceptable salt thereof, e.g., the sodium salt thereof, does not contain Des-Gly4plus Aspartimide3at a total amount greater than 0.05%, greater than 0.1%, greater than 0.5%, greater than 1.0%, greater than 1.5%, greater than 2,0%, or greater than 2.5%.

[0049] In some embodiments, apraglutide, or a pharmaceutically acceptable salt thereof, e.g., the sodium salt thereof, does not contain Des-Gly4plus Aspartimide3in an amount greater than 2.5%. In some embodiments, apraglutide, or a pharmaceutically acceptable salt thereof, e.g., the sodium salt thereof, does not contain Des-Gly4plus Aspartimide3in an amount greater than 2.0%. In some embodiments, apraglutide, or a pharmaceutically acceptable salt thereof, e.g., the sodium salt thereof, does not contain Des-Gly4plus Aspartimide3at a total amount greater than 1,0%,

[0050] In some embodiments, apraglutide, or a pharmaceutically acceptable salt thereof, e.g., the sodium salt thereof, does not contain Asp33-OH in an amount greater than 0.1%, greater than 0.5%, greater than 1.0%, greater than 1.5%, or greater than 2.0%. In some embodiments, apraglutide, or a pharmaceutically acceptable salt thereof, e.g., the sodium salt thereof, does not contain Asp33-OH in an amount greater than 2.0%. In some embodiments, apraglutide, or a pharmaceutically acceptable salt thereof, e.g., the sodium salt thereof, does not contain Asp33-OH in an amount greater than 1.5%. In some embodiments, apraglutide, or a pharmaceutically acceptable salt thereof, e.g., the sodium salt thereof, does not contain Asp33-OH in an amount greater than 1.0 %.

[0051] In some embodiments, apraglutide, or a pharmaceutically acceptable salt thereof, e.g., the sodium salt thereof, does not contain Des-Ser7in an amount greater than 0.1%, greater than 0.5%, greater than 1.0%, greater than 1.5%, or greater than 2.0%. In some embodiments, apraglutide, or a pharmaceutically acceptable salt thereof, e.g., the sodium salt thereof, does not contain Des-Ser7in an amount greater than 1.5%, In some embodiments, apraglutide, or a pharmaceutically acceptable salt thereof, e.g., the sodium salt thereof, does not contain Des-Ser7in an amount greater than 1.0%. in some embodiments, apraglutide, or a pharmaceutically acceptable salt thereof, e.g., the sodium salt thereof, does not contain Des-Ser7in an amount greater than 0.5%.

[0052] In some embodiments, apraglutide, or a pharmaceutically acceptable salt thereof, e.g., the sodium salt thereof, does not contain D-Asp3in an amount greater than 0.05%, greater than 0.1%, greater than 0.5%, greater than 1.0%, greater than 1.5%, or greater than 2.0%. In someVECT-007 / 001WO (43765-02067)embodiments, apraglutide, or a pharmaceutically acceptable salt thereof, e.g., the sodium salt thereof, does not contain D-Asp3in an amount greater than 2.0%.

[0053] In some embodiments, apraglutide, or a pharmaceutically acceptable salt thereof, e.g., the sodium salt thereof, does not contain D-Asp3in an amount greater than 1.5%. in some embodiments, apraglutide, or a pharmaceutically acceptable salt thereof, e.g., the sodium salt thereof, does not contain D-Asp3in an amount greater than 1.0%.

[0054] In some embodiments, apraglutide, or a pharmaceutically acceptable salt thereof, e.g., the sodium salt thereof, does not contain p-Asp3in an amount greater than 0.03%, greater than 0.05%, greaterthan 0.1%, greaterthan 0.5%, greater than 1.0%, greaterthan 1.5%, greaterthan 2,0%, greater than 2.5%, or greater than 3.0%. In some embodiments, apraglutide, or a pharmaceutically acceptable salt thereof, e.g., the sodium salt thereof, does not contain p-Asp3in an amount greater than 3.0%. In some embodiments, apraglutide, or a pharmaceutically acceptable salt thereof, e.g., the sodium salt thereof, does not contain [3-Asp3in an amount greater than 2.5%. In some embodiments, apraglutide, or a pharmaceutically acceptable salt thereof, e.g., the sodium salt thereof, does not contain -Asp3in an amount greater than 2.0%. In some embodiments, apraglutide, or a pharmaceutically acceptable salt thereof, e.g., the sodium salt thereof, does not contain 0-Asp3in an amount greaterthan 1.5%.

[0055] In some embodiments, apraglutide, or a pharmaceutically acceptable salt thereof, e.g., the sodium salt thereof, does not contain D-His1in an amount greater than 0.01%, greaterthan 0.05%, greaterthan 0,1%, greaterthan 0,5%, greaterthan 1.0%, greaterthan 1.2%, greaterthan 1.5%, or greater than 2,0%, In some embodiments, apraglutide, or a pharmaceutically acceptable salt thereof, e.g., the sodium salt thereof, does not contain D-His1in an amount greater than 2.0%. In some embodiments, apraglutide, or a pharmaceutically acceptable salt thereof, e.g., the sodium salt thereof, does not contain D-His1in an amount greaterthan 1,5%, In some embodiments, apraglutide, or a pharmaceutically acceptable salt thereof, e.g., the sodium salt thereof, does not contain D-His1in an amount greater than 1.2%. In some embodiments, apraglutide, or a pharmaceutically acceptable salt thereof, e.g., the sodium salt thereof, does not contain D-His1in an amount greater than 0.5%.

[0056] In some embodiments, apraglutide, or a pharmaceutically acceptable salt thereof, e.g., the sodium salt thereof, does not contain any unspecified impurity in an amount greater than 0,01%, greater than 0.05%, greater than 0,1%, greater than 0.5%, greater than 1,0%, greater than 1.5%, or greater than 2.0%. In some embodiments, apraglutide, or a pharmaceutically acceptable salt thereof, e.g., the sodium salt thereof, does not contain any unspecified impurity in an amount greater than 1.0%. In some embodiments, apraglutide, or a pharmaceuticallyVECT-007 / 001WO (43765-02067)acceptable salt thereof, e.g., the sodium salt thereof, does not contain any unspecified impurity in an amount greater than 0.5%.

[0057] In some embodiments, apraglutide, or a pharmaceutically acceptable salt thereof, e.g., the sodium salt thereof, does not contain Des-Gly4plus Aspartimide3in an amount greater than 2.5%, does not contain Asp33-OH in an amount greater than 2.0%, does not contain Des-Ser' in an amount greater than 1,5%, does not contain D-Asp3in an amount greater than 1.5%, does not contain P-Asp3in an amount greater than 2.5%, and does not contain D-His1in an amount greater than 1.5%.

[0058] In some embodiments, apraglutide, or a pharmaceutically acceptable salt thereof, e.g., the sodium salt thereof, does not contain Des-Gly4plus Aspartimide3in an amount greater than 2.5%, does not contain Asp33-OH in an amount greater than 2.0%, does not contain Des-Ser' in an amount greater than 1.5%, does not contain D-Asp3in an amount greater than 1.5%, does not contain P-Asp3in an amount greater than 2.5%, and does not contain D-His1in an amount greater than 1.5% and does not contain any unspecified impurity in an amount greater than 1.0%.

[0059] In some embodiments, apraglutide, or a pharmaceutically acceptable salt thereof, e.g., the sodium salt thereof, does not contain Des-Gly4plus Aspartimide3in an amount greater than 2.0%, does not contain Asp33-OH in an amount greater than 1.5%, does not contain Des-Ser7in an amount greater than 1.0%, does not contain D-Asp3in an amount greater than 1.0%, does not contain P-Asp3in an amount greater than 2.0%, and does not contain D-His1in an amount greater than 1.2%.

[0060] In some embodiments, apraglutide, or a pharmaceutically acceptable salt thereof, e.g., the sodium salt thereof, does not contain Des-Gly4plus Aspartimide3at a total amount greater than 2.0%, does not contain Asp33-OH in an amount greater than 1.5%, does not contain Des-Ser7in an amount greater than 1.0%, does not contain D-Asp3in an amount greater than 1.0%, does not contain P-Asp3in an amount greater than 2.0%, does not contain D-His1in an amount greater than 1.2%, and does not contain any unspecified impurity' in an amount greater than 0.5%.

[0061] In some embodiments, the apraglutide, or a pharmaceutically acceptable salt thereof, e.g., the sodium salt thereof, has a purity of no less than 94.0%, and the apraglutide, or a pharmaceutically acceptable salt thereof, e.g., the sodium salt thereof, does not contain Des-Gly4plus Aspartimide3in a total amount greater than 2.0%, does not contain Asp33-OH in an amount greater than 1.5%, does not contain Des-Ser7in an amount greater than 1.0%, does not contain D-Asp3in an amount greater than 1.0?% does not contain P-Asp3in an amount greaterVECT-007 / 001WO (43765-02067)than 2.0%, does not contain D-His1in an amount greater than 1.2%, and does not contain any unspecified impurity in an amount greater than 0.5%.

[0062] In some embodiments, the apraglutide, or a pharmaceutically acceptable salt thereof, e.g., the sodium salt thereof, does not contain Des-Gly4plus Aspartimide3in a total amount greater than 1.0%, does not contain Asp33-OH in an amount greater than 1.0%, does not contain Des-Ser7in an amount greater than 0.5%, does not contain D-Asp3in an amount greater than 1.0%, does not contain P-Asp3in an amount greater than 1.5%, and does not contain D-His1in an amount greater than 0.5%.

[0063] In some embodiments, the apraglutide, or a pharmaceutically acceptable salt thereof, e.g., the sodium salt thereof, does not contain Des-Gly4plus Aspartimide3in a total amount greater than 1.0%, does not contain Asp33-OH in an amount greater than 1.0%, does not contain Des-Ser7in an amount greater than 0.5%, does not contain D-Asp3in an amount greater than 1.0%, does not contain -Asp3in an amount greater than 1.5%, does not contain D-His1in an amount greater than 0.5%, and does not contain any unspecified impurity in an amount greater than 0.5%.

[0064] In some embodiments, the apraglutide, or a pharmaceutically acceptable salt thereof, e.g., the sodium salt thereof, has a purity' of no less than 97.0%, and the apraglutide, or a pharmaceutically acceptable salt thereof, e.g., the sodium salt thereof, does not contain Des- Gly4plus Aspartimide3in a total amount greater than 1.0%, does not contain Asp33-OH in an amount greater than 1.0%, does not contain Des-Ser ' in an amount greater than 0,5%, does not contain D-Asp3in an amount greater than 1.0%, does not contain P-Asp3in an amount greater than 1.5%, does not contain D-His1in an amount greater than 0.5%, and does not contain any unspecified impurity' in an amount greater than 0.5%.

[0065] In some embodiments, the apraglutide, or a pharmaceutically acceptable salt thereof, e.g., tire sodium salt thereof, has a purity of no less than 94.0%.

[0066] In some embodiments, the apraglutide, or a pharmaceutically acceptable salt thereof, e.g., the sodium salt thereof, comprises no more than 6.0% of the total amount of one or more of Des-Gly4+ Aspartimide3, Asp33-OH, Des-Ser ', D-Asp3, or P-Asp3as determined by HPLC.

[0067] In some embodiments, the apraglutide, or a pharmaceutically acceptable salt thereof, e.g., the sodium salt thereof, comprises no more than 6.0% of the total amount of one or more of Des-Gly4+ Aspartimide3, Asp33-OH, Des-Ser', D-Asp3, -Asp3, or D-His1as determined by HPLC.

[0068] In some embodiments, the apraglutide, or a pharmaceutically acceptable salt thereof, e.g., the sodium salt thereof, comprises no more than about 2.0% of Des-Gly4+ Aspartimide3VECT-007 / 001WO (43765-02067)as determined by HPLC.

[0069] In some embodiments, tire apraglutide, or a pharmaceutically acceptable salt thereof, e.g., the sodium salt thereof, comprises no more than about 2.0% of -Asp3as determined by HPLC.

[0070] In some embodiments, the apraglutide, or a pharmaceutically acceptable salt thereof, e.g., the sodium salt thereof, comprises no more than about 1.0% of D-Asp3as determined by HPLC.

[0071] In some embodiments, the apraglutide, or a pharmaceutically acceptable salt thereof, e.g., the sodium salt thereof, comprises no more than about 1.0% of Des-Ser7as determined by HPLC.

[0072] In some embodiments, the apraglutide, or a pharmaceutically acceptable salt thereof, e.g., the sodium salt thereof, comprises no more than about 1.5% of Asp33-OH as determined by HPLC.

[0073] In some embodiments, the apraglutide, or a pharmaceutically acceptable salt thereof, e.g., the sodium salt thereof, comprises no more than about 1.2% of D-His1as determined by HPLC.

[0074] In some embodiments, the apraglutide, or a pharmaceutically acceptable salt thereof, e.g., tire sodium salt thereof, comprises:a) no more than about 2.0% of P-Asp3as determined by HPLC;b) no more than about 2.0% of Des-Gly4+ Aspartimide3as determined by HPLC; c) no more than about 1.0% of Des-Ser' as determined by HPLC;d) no more than about \.5% of Asp33-OH as determined by HPLC;e) no more than about 1.0% of D-Asp3as determined by HPLC, and / orf) no more than about 1,2% of D-His1as determined by HPLC,provided that the total amount of the p-Asp3. Des-Gly4+ Aspartimide3, Des-Ser7, Asp33-OH, D- Asp3, and D-His1apraglutide impurities is no more than about 6.0% as determined by HPLC.

[0075] In some embodiments, the apraglutide, or a pharmaceutically acceptable salt thereof, e.g., the sodium salt thereof, comprises:a) no more than about 2.0% of P-Asp3as determined by HPLC;b) no more than about 2,0% of Des-Gly4+ Aspartimide3as determined by HPLC; c) no more than about 1.0% of Des-Ser7as determined by HPLC;d) no more than about 1.5% of Asp33-OH as determined by HPLC;e) no more than about 1.0% of D-Asp3as determined by HPLC;VECT-007 / 001WO (43765-02067)f) no more than about 1.2% of D-His1as determined by HPLC, and / org) no more than about 0.5% of any unspecified impurity,provided that the total amount of the P~Asp3, Des-Gly4+ Aspartimide3, Des-Ser7, Asp33-OH, D- Asp3, and D-His1apraglutide impurities is no more than about 6.0% as determined by HPLC.

[0076] In some embodiments, the apraglutide, or a pharmaceutically acceptable salt thereof, e.g., the sodium salt thereof, comprises:a) no more than about 2.0% of -Asp3as determined by HPLC;b) no more than about 2.0% of Des-Gly4+ Aspartimide3as determined by HPLC; c) no more than about 1,0% of Des-Ser7as determined by HPLC;d) no more than about 1.5% of Asp33-OH as determined by HPLC;e) no more than about 1.0% of D-Asp3as determined by HPLC, and / orf) no more than about 1.2% of D-His1as determined by HPLC,provided that the total amount of impurities is no more than about 6.0% as determined by HPLC.

[0077] In some embodiments, die apraglutide, or a pharmaceutically acceptable salt thereof, e.g., the sodium salt thereof, comprises:a) no more than about 2.0% of 0-AspJas determined by HPLC;b) no more than about 2.0% of Des-Gly4+ Aspartimide3as determined by HPLC; c) no more than about 1.0% of Des-Ser' as determined by HPLC;d) no more than about 1.5% of Asp33-OH as determined by HPLC;e) no more than about 1.0% of D-Asp3as determined by HPLC;f) no more than about 1.2% of D-His1as determined by HPLC, and / org) no more than about 0,5% of any unspecified impurity,provided that die total amount of impurities is no more than about 6.0% as determined by HPLC.

[0078] In some embodiments, the apraglutide, or a pharmaceutically acceptable salt thereof, e.g., the sodium salt thereof, comprises no more than about 0.5% of any unspecified impurity as determined by HPLC.

[0079] In some embodiments, die apraglutide, or a pharmaceutically acceptable salt thereof, e.g., the sodium salt thereof, comprises no more than about 6.0% total impurities as determined by HPLC.

[0080] In some embodiments, the apraglutide, or a pharmaceutically acceptable salt thereof, e.g., the sodium salt thereof, comprises no more than about 5 EU / mg of bacterial endotoxins.VECT-007 / 001WO (43765-02067)Dosing and Administration

[0081] In some embodiments, the apraglutide, or a pharmaceutically acceptable salt thereof, e.g., the sodium salt thereof, is administered to the subject.

[0082] In some embodiments, apraglutide is administered.

[0083] In some embodiments, a pharmaceutically acceptable salt, e.g., the sodium salt of apraglutide is administered.

[0084] In some embodiments, a sodium salt of apraglutide is administered.

[0085] In some embodiments, the apraglutide or a pharmaceutically acceptable salt thereof, e.g., tire sodium salt thereof, is administered parenterally.

[0086] In some embodiments, the apraglutide or a pharmaceutically acceptable salt thereof, e.g., the sodium salt thereof, is administered by subcutaneous injection.

[0087] In some embodiments, a pharmaceutical composition comprising the apraglutide or a pharmaceutically acceptable salt thereof, e.g., the sodium salt thereof, is administered.

[0088] In some embodiments, the pharmaceutical composition is administered parenterally.

[0089] In some embodiments, the pharmaceutical composition is administered by subcutaneous injection.

[0090] In some embodiments, the pharmaceutical composition is a formulation suitable for parenteral administration (e.g., subcutaneous injection).

[0091] Formulations suitable for parenteral administration include aqueous and non-aqueous, isotonic sterile injection solutions, which can contain antioxidants, buffers, bacteriostatics, and solutes that render the formulation isotonic with the blood of the intended recipient, and aqueous and non-aqueous sterile suspensions that can include suspending agents, solubilizers, thickening agents, stabilizers, and preservatives. Liquid carriers, for injectable solutions, include by way of example and without limitation water, saline, aqueous dextrose and glycols.

[0092] In some embodiments, the apraglutide or a pharmaceutically acceptable salt thereof, e.g., the sodium salt thereof, is delivered via a two-chamber syringe or dual cartridge injector. One example of such a syringe is described in PCT / EP2012 / 000787, the contents of which are incorporated herein by reference.

[0093] Suitable sites for subcutaneous injection include the four quadrants of the abdomen and thighs. In some embodiments, apraglutide, or a pharmaceutically acceptable salt thereof, e.g., the sodium salt thereof, is administered subcutaneously, alternating between the four quadrants of the abdomen. In some embodiments, apraglutide, or a pharmaceutical composition comprising the same, is administered subcutaneously, alternating between thighs.VECT-007 / 001WO (43765-02067)

[0094] Weights for apraglutide in a dosage or a formulation listed herein are given for the amount of apraglutide without any salt appendages. For example, when apraglutide is in the sodium salt form, only the weight of apraglutide without the sodium counterions is taken into account when listing the weight of apraglutide in a dosage or a formulation. In some embodiments, the content of apraglutide without any counterions in a sample can be measured by reverse phase ultra performance liquid chromatography using an external reference standard for apraglutide.

[0095] In some embodiments, the subject has a body weight of 50 kg or greater, and the apraglutide or a pharmaceutically acceptable salt thereof, e.g., the sodium salt thereof, is administered at a dose of 3.6 1.0 mg, 3.6i0.9 mg, 3.6±0.8 mg, 3.6 0.7 mg, 3.6±0.6 mg, 3.6±0.5 mg, 3.6±0.4 mg, 3.6±0.3 mg, 3.6±0.2 mg, or 3.6±0.1 mg (e.g., about 3.6 mg).

[0096] In some embodiments, the subject has a body weight of 50 kg or greater, and the apraglutide or a pharmaceutically acceptable salt thereof, e.g,, the sodium salt thereof, is administered at a dose of 3.5 1.0 mg, 3.5±0.9 mg, 3.5±0.8 mg, 3.5±0.7 mg, 3.5i0.6 mg, 3.5±0.5 mg, 3.5±0.4 mg, 3.5±0.3 mg, 3.5±0.2 mg, or 3.5±0.1 mg (e.g., about 3.5 mg).

[0097] In some embodiments, the subject has a body weight of 50 kg or greater, and the apraglutide or a pharmaceutically acceptable salt thereof, e.g., the sodium salt thereof, is administered at a dose of 4.8 1.0 mg, 4.8±0.9 mg, 4.8±0.8 mg, 4.8±0.7 mg, 4.8i0.6 mg, 4.8±0.5 mg, 4.8±0.4 mg, 4.8±0.3 mg, 4.8±0.2 mg, or 4.8±0.1 mg (e.g., about 4.8 mg).

[0098] In some embodiments, the subject has a body weight of 50 kg or greater, and the apraglutide or a pharmaceutically acceptable salt thereof, e.g., the sodium salt thereof, is administered at a dose of 5.3±1.0 mg, 5.3±0.9 mg, 5.3±0.8 mg, 5.3±0.7 mg, 5.3±0.6 mg, 5.3±0.5 mg, 5.3±0.4 mg, 5.3±0.3 mg, 5.3±0.2 mg, or 5.3±0.1 mg (e.g., about 5.3 mg).

[0099] In some embodiments, a subject may be administered a first course of treatment with a dose of apraglutide, e.g., about 3.5 mg, and evaluated for a clinical response. Tire clinical response definition is based on clinical practice guidelines and relies on the composite evaluation of factors leading to the maintenance or modification of the parenteral support regimen. Such factors may include, without limitation: increased intestinal absorption of dietary intake w et w eight of the subject, a decreased fecal output of the subject, an increased absolute urine volume output of the subject, and / or an increased intestinal absorption of energy of the subject. In some embodiments, where a subject has not had a clinical response, the dose of apraglutide may be increased. The increased dose of apraglutide can be about 4.8 mg. Alternatively, the increased dose of apraglutide can be about 5.3 mg. In some embodiments, the subject has a body weight less than 50 kg, and the apraglutide or a pharmaceuticallyVECT-007 / 001WO (43765-02067)acceptable salt thereof, e.g., the sodium salt thereof, is administered at a dose of 1.4+1.0 mg, 1.4+0.9 mg, 1.4+0.8 mg, 1.4+0.7 mg, 1.4+0.6 mg, 1.4+0.5 mg, 1.4+0.4 mg, 1.4+0.3 mg, 1, 4+0.2 mg, or 1.4+0.1 mg (e.g., about 1.4 mg).|00100| In some embodiments, the subject has a body weight less than 50 kg, and the apraglutide or a pharmaceutically acceptable salt thereof, e.g., the sodium salt thereof, is administered at a dose of 1.5+1.0 mg, 1.5+0, 9 mg, 1.5+0.8 mg, 1.5+0.7 mg, 1,5+0.6 mg, 1.5+0.5 mg, 1.5+0.4 mg, 1.5+0.3 mg, 1.5+0.2 mg, or 1.5+0.1 mg (e.g., about 1.5 mg).

[0101] In some embodiments, the subject has a body weight less than 50 kg, and the apraglutide or a pharmaceutically acceptable salt thereof, e.g., the sodium salt thereof, is administered at a dose of 2.2+1.0 mg, 2.2+0.9 mg, 2.2+0.8 mg, 2.2+0.7 mg, 2.2+0.6 mg, 2.2+0.5 mg, 2.2+0.4 mg, 2.2+0.3 mg, 2.2+0.2 mg, or 2.2+0.1 mg (e.g., about 2.2 mg).

[0102] In some embodiments, the subject has body weight less than 50 kg, and the apraglutide or a pharmaceutically acceptable salt thereof, e.g,, the sodium salt thereof, is administered at a weekly dose of about 0.4 mg, 0.5 mg, about 0.6 mg, about 0.7 mg, about 0.8 mg, about 0.9 mg, about 1.0 mg, about 1.1 mg, about 1.2 mg, about 1.3 mg, about 1.4 mg, about 1.5 mg, about 1.6 mg, about 1.7 mg, about 1.8 mg, about 1.9 mg, about 2.0 mg, about 2.1 mg, about 2.2 mg, about 2.3 mg, about 2.4 mg, about 2,5 mg, about 2,6 mg, about 2.7 mg, about 2.8 mg, about 2.9 mg, about 3.0 mg, about 3.1 mg, or about 3.2 mg of apraglutide.

[0103] In some embodiments, the subject has body weight less than 50 kg, and the apraglutide or a pharmaceutically acceptable salt thereof, e.g,, the sodium salt thereof, is administered at a weekly dose of about 1.4 mg of apraglutide.

[0104] In some embodiments, the subject has body weight less than 50 kg, and the apraglutide or a pharmaceutically acceptable salt thereof, e.g., the sodium salt thereof, is administered at a weekly dose of about 1.5 mg of apraglutide,

[0105] In some embodiments, the subject has body weight less than 50 kg, and the apraglutide or a pharmaceutically acceptable salt thereof, e.g., the sodium salt thereof, is administered at a weekly dose of about 2.2 mg of apraglutide.

[0106] In some embodiments, the subject has body weight of 50 kg or greater, and the apraglutide or a pharmaceutically acceptable salt thereof, e.g., the sodium salt thereof, is administered at a weekly dose of about 2.5 mg, 2.6 mg, about 2.7 mg, about 2.8 mg, about 2.9 mg, about 3.0 mg, about 3.1 mg, about 3,2 mg, about 3.3 mg, about 3,4 mg, about 3.5 mg, about 3.6 mg, about 3.7 mg, about 3.8 mg, about 3.9 mg, about 4.0 mg, about 4.1 mg, about 4.2 mg, about 4.3 mg, about 4.4 mg, about 4.5 mg, about 4.6 mg, or about 4.7 mg.

[0107] In some embodiments, the subject has body weight of 50 kg or greater, and theVECT-007 / 001WO (43765-02067)apraglutide or a pharmaceutically acceptable salt thereof, e.g., the sodium salt thereof, is administered at a weekly dose of about 3.5 mg apraglutide.

[0108] In some embodiments, the subject has body weight of 50 kg or greater, and the apraglutide or a pharmaceutically acceptable salt thereof, e.g., the sodium salt thereof, is administered at a weekly dose of about 3.6 mg apraglutide.

[0109] In some embodiments:the subject has a body weight of 50 kg or greater, and apraglutide or a pharmaceutically acceptable salt thereof, e.g., the sodium salt thereof, is administered at a dose of about 3.6 mg of apraglutide; orthe subject has a body weight less than 50 kg, and the apraglutide or a pharmaceutically acceptable salt thereof, e.g., the sodium salt thereof, is administered at a dose of about 1.5 mg of apraglutide.

[0110] In some embodiments, the subject has a body weight of 50 kg or greater, and apraglutide or a pharmaceutically acceptable salt thereof, e.g., the sodium salt thereof, is administered at a dose of about 3.6 mg of apraglutide.

[0111] In some embodiments, the subject has a body weight of 50 kg or greater, and apraglutide or a pharmaceutically acceptable salt thereof, e.g., the sodium salt thereof, is administered at a dose of about 3.5 mg of apraglutide.

[0112] In some embodiments, the subject has a body weight less than 50 kg, and the apraglutide or a pharmaceutically acceptable salt thereof, e.g,, the sodium salt thereof, is administered at a dose of about 1.5 mg of apraglutide.

[0113] In some embodiments, the subject has a body weight less than 50 kg, and the apraglutide or a pharmaceutically acceptable salt thereof, e.g., the sodium salt thereof, is administered at a dose of about 1,4 mg of apraglutide.

[0114] In some embodiments, the subject has a body weight less than 50 kg, and the apraglutide or a pharmaceutically acceptable salt thereof, e.g., the sodium salt thereof, is administered at a dose of about 2.2 mg of apraglutide.

[0115] Without wishing to be bound by theory', it is believed that due to the non-linear increase of exposures (AUC and Cmax) as body weight decreases, it is desired to dose patients with body weight below 50 kg with 1.5 mg apraglutide to prevent high exposures. Patients of 50 kg or higher receive 3,6 mg doses of apraglutide. In some embodiments, the apraglutide is administered as prepared from a pharmaceutically acceptable salt, e.g., the sodium salt thereof.

[0116] Without wishing to be bound by theory, it is believed that due to the non-linear increase of exposures (AU C and Cmax) as body weight decreases, it is desired to dose patientsVECT-007 / 001WO (43765-02067)with body weight below 50 kg with 2.2 mg apraglutide to prevent high exposures. Patients of 50 kg or higher receive 3.5 mg doses of apraglutide. In some embodiments, the apraglutide is administered as prepared from a pharmaceutically acceptable salt, e.g., the sodium salt thereof.|00117| Without wishing to be bound by theory, it is believed that due to the non-linear increase of exposures (AUC and Cmax) as body weight decreases, it is desired to dose patients with body weight below 50 kg with 1,4 mg apraglutide to prevent high exposures. Patients of 50 kg or higher receive 3.5 mg doses of apraglutide. In some embodiments, the apraglutide is administered as prepared from a pharmaceutically acceptable salt, e.g., the sodium salt thereof.

[0118] In some embodiments, the administered dose of apraglutide is about 2.0 mg or more, about 2.1 mg or more, about 2.2 mg or more, about 2.3 mg or more, about 2.4 mg or more, about 2.5 mg or more, about 3.0 mg or more, about 3.5 mg or more, about 3.6 mg or more, about 3.7 mg or more, about 3.8 mg or more, about 3.9 mg or more, about 4.0 mg or more, about 4,5 mg or more, about 5.0 mg or more, about 5.3 mg or more, about 5.5 mg or more, about 5.7 mg or more, about 6.0 mg or more, about 6.2 mg or more, about 6.5 mg or more, or about 7.0 mg or more. In some embodiments, the administered dose of apraglutide is about 7.5 mg or less, about 7.0 mg or less, about 6.5 mg or less, about 6.0 mg or less, about 5.5 mg or less, about 5.0 mg or less, about 4.5 mg or less, or about 4,0 mg or less,

[0119] In some embodiments, the administered dose of apraglutide ranges from about 2.1 mg to about 2.3 mg. In some embodiments, tire administered dose of apraglutide ranges from about 3.5 mg to about 4,0 mg. In some embodiments, the administered dose of apraglutide ranges from about 4.0 mg to about 7.5 mg. In some embodiments, doses within the range of about 4.0 mg to about 7.5 mg are provided (e.g., about 4.0 mg, about 4.5 mg, about 5.0 mg, about 5.5 mg, about 6.0 mg, about 6.5 mg, about 7.0 mg, or about 7.5 mg).

[0120] In some embodiments, the administered dose of apraglutide ranges from about 4.0 mg to about 6.0 mg.

[0121] In some embodiments, the administered dose of apraglutide ranges from about 4.0 mg to about 4, 1 mg, from about 4.1 mg to about 4.2 mg, from about 4.2 mg to about 4.3 mg, from about 4.3 mg to about 4.4 mg, from about 4.4 mg to about 4.5 mg, from about 4.5 mg to about 4.6 mg, from about 4.6 mg to about 4.7 mg, from about 4.7 mg to about 4.8 mg, from about 4.8 mg to about 4.9 mg, from about 4.9 mg to about 5.0 mg, from about 5.0 mg to about 5,1 mg, from about 5.1 mg to about 5.2 mg, from about 5,2 mg to about 5.3 mg, from about 5.3 mg to about 5.4 mg, from about 5.4 mg to about 5.5 mg, from about 5.5 mg to about 5.6 mg, from about 5.6 mg to about 5.7 mg, from about 5.7 mg to about 5.8 mg, from about 5.8 mg to about 5.9 mg, and from about 5.9 mg to about 6.0 mg.VECT-007 / 001WO (43765-02067)

[0122] In some embodiments, the administered dose of apraglutide is about 4.0 mg. In some embodiments, the administered dose of apraglutide is about 4.1 mg. In some embodiments, the administered dose of apraglutide is about 4.2 mg. In some embodiments, the administered dose of apraglutide is about 4.3 mg. In some embodiments, the administered dose of apraglutide is about 4.4 mg. In some embodiments, the administered dose of apraglutide is about 4,5 mg. In some embodiments, the administered dose of apraglutide is about 4.6 mg. In some embodiments, the administered dose of apraglutide is about 4.7 mg. In some embodiments, the administered dose of apraglutide is about 4.8 mg. In some embodiments, the administered dose of apraglutide is about 4.9 mg. In some embodiments, the administered dose of apraglutide is about 5.0 mg. In some embodiments, the administered dose of apraglutide is about 5.1 mg. In some embodiments, the administered dose of apraglutide is about 5.2 mg. In some embodiments, the administered dose of apraglutide is about 5.3 mg. In some embodiments, the administered dose of apraglutide is about 5.4 mg. In some embodiments, the administered dose of apraglutide is about 5.5 mg. In some embodiments, the administered dose of apraglutide is about 5.6 mg. In some embodiments, the administered dose of apraglutide is about 5.7 mg. In some embodiments, the administered dose of apraglutide is about 5.8 mg. In some embodiments, the administered dose of apraglutide is about 5.9 mg. In some embodiments, the administered dose of apraglutide is about 6.0 mg.

[0123] In some embodiments, the apraglutide is lyophilized.

[0124] In some embodiments, the apraglutide is present in a container. In some embodiments, the container is a vial. In some embodiments, the container is a bottle. In some embodiments, the container is an ampoule. In some embodiments, the container is a bag.

[0125] The amount in a container may be a single dose. In some embodiments, the amount in the container may contain more than one dose, e.g., two doses.

[0126] In some embodiments, the container is a vial. In some embodiments, the total content per container is about 5.4 mg of apraglutide, or about 10.4 mg of apraglutide.

[0127] In some embodiments, the drug product is a solution. Tire solution may be prepared by adding a quantity of diluent, thereby providing a reconstituted formulation.

[0128] In some embodiments, the diluent is water.

[0129] In some embodiments, the water is sterile, e.g., sterile water for injection.

[0130] In some embodiments, the apraglutide concentration in the reconstituted formulation ranges from about 8.8 mg / mL to about 20.6 mg / mL.

[0131] In some embodiments, the apraglutide drug product is present in a container, e.g., in a solution in tire container, e.g., a reconstituted formulation in sterile water. TheVECT-007 / 001WO (43765-02067)container may be a vial. In some embodiments, the total content per vial is about 5.4 mg or about 10.4 mg of apraglutide. In some embodiments, the vial contains about 5.4 mg or about 10.4 mg of apraglutide in a reconstituted solution having a concentration of apraglutide of about 8.8 mg / mL. In some embodiments, the total content per vial is about 5.4 mg or about 10.4 mg of apraglutide in a reconstituted solution, wherein the apraglutide concentration ranges from about 8.8 mg / mL to about 20.6 mg / mL.

[0132] In some embodiments, the apraglutide is administered in an amount ranging from about 3.5 mg to about 4.0 mg, from about 3.4 mg to about 3.6 mg, or in an amount ranging from about 2.1 mg to about 2.3 mg. In some embodiments, the total content per vial is about 5.4 mg of apraglutide. In some embodiments, the vial contains about 5.4 mg of apraglutide in a reconstituted solution having a concentration that ranges from about 8.8 mg / mL to about 20.6 mg / mL.

[0133] In some embodiments, the reconstituted formulation is prepared by the addition of a diluent in an effective added reconstitution volume greater than or equal to about 0.35 mL. In some embodiments, the effective added reconstitution volume is less than about 0.35 mL.

[0134] In some embodiments, the apraglutide is administered in an amount ranging from about 3.5 mg to about 4.0 mg, or in an amount ranging from about 2.1 mg to about 2.3 mg.

[0135] In some embodiments, the total content per vial is about 10.4 mg of apraglutide, wherein the reconstituted formulation concentration ranges from about 8.8 mg / mL to about 20.6 mg / mL, In some embodiments, the reconstituted formulation is prepared by the addition of a diluent in an effective added reconstitution volume greater than or equal to about 0.35 mL. In some embodiments, the effective added reconstitution volume is less than about 0.35 mL.

[0136] In some embodiments, tire apraglutide is administered in an amount ranging from about 4.0 mg to about 7.5 mg.

[0137] In some embodiments, the total content per vial is about 5.4 mg or about 10.4 mg of apraglutide, wherein the reconstituted apraglutide concentration is about 8.8 mg / mL, In some embodiments, the reconstituted formulation is prepared by the addition of a diluent in an effective added reconstitution volume greater than or equal to about 0,35 mL. In some embodiments, the effective added reconstitution volume is less than about 0.35 mL.

[0138] In some embodiments, tire apraglutide is administered in an amount ranging from about 4.0 mg to about 7.5 mg. In some embodiments, the total content per vial is about 5.4 mg of apraglutide, wherein the apraglutide concentration ranges from about 8.8 mg / mL to about 20.6 mg / mL. In some embodiments, the reconstituted formulation is prepared by the addition of a diluent in an effective added reconstitution volume greater than or equal to aboutVECT-007 / 001WO (43765-02067)0.35 mL. In some embodiments, the effective added reconstitution volume is less than about 0.35 mL.

[0139] In some embodiments, the apraglutide is administered in an amount ranging from about 4.0 mg to about 7.5 mg. In some embodiments, tire total content per vial is about 10.4 mg of apraglutide, wherein the reconstituted apraglutide concentration ranges from about 8.8 mg / mL to about 20.6mg / mL, In some embodiments, the reconstituted formulation is prepared by the addition of a diluent in an effective added reconstitution volume greater than or equal to about 0.35 mL. In some embodiments, the effective added reconstitution volume is less than about 0.35 mL.Subjects and Indications

[0140] In some embodiments, the subject is a human.

[0141] In some embodiments, the subject is an adult, i.e., a subject aged 18 years or older.

[0142] In some embodiments, the subject is dependent on parenteral support (PS).

[0143] In some embodiments, the subject is an adult subject dependent on PS.

[0144] In some embodiments, within about six months prior to starting apraglutide treatment, the subject has received a colonoscopy.

[0145] In some embodiments, the subject has had polyps removed.

[0146] In some embodiments, within about six months prior to starting apraglutide treatment, the subject has baseline laboratory assessments. Such assessments include, for example and without limitation, bilirubin, alkaline phosphatase, lipase, and amylase levels.

[0147] In some embodiments, a subject who has been administered an effective dose of apraglutide or a pharmaceutically acceptable salt thereof, e.g., the sodium salt thereof, needs less nutritional support (e.g., PN) relative to a control. For example, in some embodiments, a subject who has been administered an effective dose of apraglutide or a pharmaceutically acceptable salt thereof, e.g., the sodium salt thereof, needs at least 10%, at least 20%, at least 30%, at least 40%, at least 50%, at least 60%, at least 70%, at least 80%, or at least 90% less nutritional support relative to a control. In one embodiment, a subject who has been administered an effective dose of apraglutide or a pharmaceutically acceptable salt thereof, e.g., the sodium salt thereof, needs 100% less nutritional support relative to a control (i.e., the subject has achieved enteral autonomy).

[0148] In some embodiments, a subject who has been administered an effective dose of apraglutide or a pharmaceutically acceptable salt thereof, e.g., the sodium salt thereof, needsVECT-007 / 001WO (43765-02067)total parenteral support for fewer days relative to a control. For example, in some embodiments, administration of an effective dose of apraglutide or a pharmaceutically acceptable salt thereof, e.g., the sodium salt thereof, may reduce the length of time during which total parenteral support is needed by at least 20%, at least 25%, at least 30%, at least 35%, at least 40%, at least 45 %, at least 50%, at least 55%, at least 60%, at least 65%, at least 70%, at least 75%, at least 80%, at least 85%, at least 90%, at least 95% relative to a control. In some embodiments, administration of an effective dose of apraglutide or a pharmaceutically acceptable salt thereof, e.g., the sodium salt thereof, reduces the length of time during which total parenteral support is needed by 100% relative to a control (i.e., the subject has achieved enteral autonomy). In some embodiments, a subject who has been administered an effective dose of apraglutide or a pharmaceutically acceptable salt thereof, e.g., tire sodium salt thereof, needs total parenteral support for less than 85 days per year, less than 80 days per year, less than 75 days per year, less than 70 days per year, less than 65 days per year, less than 60 days per year, less than 55 days per year, less than 50 days per year, less than 45 days per year, less than 40 days per year, less than 35 days per year, less than 30 days per year, less than 25 days per year, less than 20 days per year, less than 15 days per year, less than 10 days per year, or less than 5 days per year. In some embodiments, a subject who has been administered an effective dose of apraglutide or a pharmaceutically acceptable salt thereof, e.g., the sodium salt thereof, needs total parenteral support for less than 7 days per week, less than 6 days per week, less than 5 days per week, less than 4 days per week, less than 3 days per week, less than 2 days per week, or one day per week.

[0149] In some embodiments, a subject who is administered an effective dose of apraglutide or a pharmaceutically acceptable salt thereof, e.g., the sodium salt thereof, does not need total parenteral nutrition following treatment.

[0150] In some aspects, provided herein is a method for increasing the intestinal absorption of wet weight in a subject with short bowel syndrome, the method comprising administering to the subject at least one therapeutically effective amount of apraglutide or a pharmaceutically acceptable salt thereof, e.g., the sodium salt thereof. In some aspects, provided herein is apraglutide or a pharmaceutically acceptable salt thereof, e.g., the sodium salt thereof, for use in a method of increasing the intestinal absorption of wet weight in a subject with short bowel syndrome, wherein the apraglutide or a pharmaceutically acceptable salt thereof, e.g., the sodium salt thereof, is for administration to the subject in at least one therapeutically effective amount. In some aspects, provided herein is apraglutide or a pharmaceutically acceptable salt thereof, e.g., the sodium salt thereof, for use in theVECT-007 / 001WO (43765-02067)manufacture of a medicament for increasing the intestinal absorption of wet weight in a subject with short bowel syndrome, wherein the apraglutide or a pharmaceutically acceptable salt thereof, e.g., the sodium salt thereof, is for administration to the subject in at least one therapeutically effective amount, in some embodiments, the increase in intestinal absorption of wet weight can be at least about 100 g / day, or at least about 200 g / day, or at least about 300 g / day, or at least about 400 g / day, or at least about 500 g / day, or at least about 600 g / day, or at least about 700 g / day, or at least about 800 g / day, or at least about 900 g / day, or at least about 1000 g / day. In some embodiments, the increase in intestinal absorption of wet weight is at least about 700 g / day, at least about 720 g / day, or at least about 740 g / day. In some embodiments, the increase in intestinal absorption of wet weight is at least about 740 g / day.|00151| In some aspects, provided herein is a method for decreasing fecal output in a subject with short bowel syndrome, the method comprising administering to the subject at least one therapeutically effective amount of apraglutide or a pharmaceutically acceptable salt thereof, e.g., the sodium salt thereof. In some aspects, provided herein is a method for decreasing stoma output in a subject with short bowel syndrome, the method comprising administering to the subject at least one therapeutically effective amount of apraglutide or a pharmaceutically acceptable salt thereof, e.g., the sodium salt thereof. In some aspects, provided herein is apraglutide or a pharmaceutically acceptable salt thereof, e.g., the sodium salt thereof, for use in a method of decreasing the fecal output in a subject with short bowel syndrome, wherein the apraglutide or a pharmaceutically acceptable salt thereof, e.g., the sodium salt thereof, is for administration to the subject in at least one therapeutically effective amount. In some aspects, provided herein is apraglutide or a pharmaceutically acceptable salt thereof, e.g., the sodium salt thereof, for use in the manufacture of a medicament for decreasing the fecal output in a subject with short bowel syndrome, wherein the apraglutide or a pharmaceutically acceptable salt thereof, e.g., the sodium salt thereof, is for administration to the subject in at least one therapeutically effective amount. In some embodiments, the decrease in fecal output can be at least about 100 g / day, or at least about 200 g / day, or at least about 300 g / day, or at least about 400 g / day, or at least about 500 g / day, or at least about 600 g / day, or at least about 700 g / day, or at least about 800 g / day, or at least about 900 g / day, or at least about 1000 g / day. In some embodiments, the decrease in fecal output is at least about 600 g / day, at least about 620 g / day, at least about 640 g / day, at least about 660 g / day, or at least about 680 g / day. In some embodiments, the decrease in fecal output is at least about 680 g / day.|00152| In some aspects, provided herein is a method for increasing urine production in a subject with short bowel syndrome, tire method comprising administering to the subject atVECT-007 / 001WO (43765-02067)least one therapeutically effective amount of apraglutide or a pharmaceutically acceptable salt thereof, e.g., tire sodium salt thereof In some aspects, provided herein is apraglutide or a pharmaceutically acceptable salt thereof, e.g., the sodium salt thereof, for use in a method of increasing the urine production in a subject with short bowel syndrome, wherein tire apraglutide or a pharmaceutically acceptable salt thereof, e.g., the sodium salt thereof, is for administration to the subject in at least one therapeutically effective amount. In some aspects, provided herein is apraglutide or a pharmaceutically acceptable salt thereof, e.g., the sodium salt thereof, for use in the manufacture of a medicament for increasing the urine production in a subject with short bowel syndrome, wherein the apraglutide or a pharmaceutically acceptable salt thereof, e.g., the sodium salt thereof, is for administration to the subject in at least one therapeutically effective amount. In some embodiments, the increase in urine production can be at least about 100 g / day, or at least about 200 g / day, or at least about 300 g / day, or at least about 400 g / day, or at least about 500 g / day, or at least about 600 g / day, or at least about 700 g / day, or at least about 800 g / day, or at least about 900 g / day, or at least about 1000 g / day. In some embodiments, the increase in urine production can be at least about 500 g / day, at least about 520 g / day, at least about 540 g / day, or at least about 560 g / day. In some embodiments, the increase in urine production is at least about 560 g / day.

[0153] In some aspects, provided herein is a method for increasing intestinal absorption of energy in a subject with short bowel syndrome, the method comprising administering to the subject at least one therapeutically effective amount of apraglutide or a pharmaceutically acceptable salt thereof, e.g., the sodium salt thereof. In some aspects, provided herein is apraglutide or a pharmaceutically acceptable salt thereof, e.g., the sodium salt thereof, for use in a method of increasing tire intestinal absorption of energy in a subject with short bowel syndrome, wherein the apraglutide or a pharmaceutically acceptable salt thereof, e.g., the sodium salt thereof, is for administration to the subject in at least one therapeutically effective amount. In some aspects, provided herein is apraglutide or a pharmaceutically acceptable salt thereof, e.g., the sodium salt thereof, for use in the manufacture of a medicament for increasing the intestinal absorption of energy in a subject with short bowel syndrome, wherein the apraglutide or a pharmaceutically acceptable salt thereof, e.g., the sodium salt thereof, is for administration to the subject in at least one therapeutically effective amount. In some embodiments, the increased intestinal absorption of energy can be at least about 500 kJ / day, or at least about 600 kJ / day, or at least about 700 kJ / day, or at least about 800 kJ / day, or at least about 900 kJ / day, or at least about 1000 kJ / day, or at least about 1100 kJ / day or at least about 1200 kJ / day. In some embodiments, the increased intestinal absoiption of energy is at leastVECT-007 / 001WO (43765-02067)about 1000 kJ / day, at least about 1025 kJ / day, at least about 1050 kJ / day, at least about 1075 kJ / day, at least about 1090kJ / day, or at least about 1095 kJ / day. In some embodiments, the increased intestinal absorption of energy is at least about 1095 kJ / day.|00154| In some aspects, provided herein is a method for increasing the concentration of L-citrulline in plasma in a subject with short bowel syndrome, the method comprising administering to the subject at least one therapeutically effective amount of apraglutide or a pharmaceutically acceptable salt thereof, e.g., the sodium salt thereof. In some aspects, provided herein is apraglutide or a pharmaceutically acceptable salt thereof, e.g., the sodium salt thereof, for use in a method of increasing the concentration of L-citrulline in plasma in a subject with short bowel syndrome, wherein the apraglutide or a pharmaceutically acceptable salt thereof, e.g., the sodium salt thereof, is for administration to the subject in at least one therapeutically effective amount. In some aspects, provided herein is apraglutide or a pharmaceutically acceptable salt thereof, e.g., the sodium salt thereof, for use in the manufacture of a medicament for increasing the concentration of L-citrulline in plasma in a subject with short bowel syndrome, wherein the apraglutide or a pharmaceutically acceptable salt thereof, e.g., the sodium salt thereof, is for administration to the subject in at least one therapeutically effective amount. In some embodiments, the increase in concentration in L-citrulline in plasma can be at least about 5 pmol / L, or at least about 10 umol / L, or at least about 15 µmol / L, or at least about 20 µmol / L.

[0155] Plasma citrulline concentration may remain elevated after terminating apraglutide treatment in a subject previously receiving apraglutide or a pharmaceutically acceptable salt thereof, e.g., the sodium salt thereof. In some embodiments, plasma citrulline concentration remains elevated relative to baseline for at least one week, at least two weeks, at least three weeks, at least four weeks, at least five weeks, or at least six weeks after apraglutide treatment.

[0156] In some aspects, provided herein is a method for increasing urine volume output in a subject with short bowel syndrome, the method comprising administering to the subject at least one therapeutically effective amount of apraglutide or a pharmaceutically acceptable salt thereof, e.g., the sodium salt thereof. In some aspects, provided herein is apraglutide or a pharmaceutically acceptable salt thereof, e.g., the sodium salt thereof, for use in a method of increasing urine volume output in a subject with short bowel syndrome, wherein the apraglutide or a pharmaceutically acceptable salt thereof, e.g., the sodium salt thereof, is for administration to the subject in at least one therapeutically effective amount. In some aspects, provided herein is apraglutide or a pharmaceutically acceptable salt thereof, e.g., the sodium salt thereof, forVECT-007 / 001WO (43765-02067)use in the manufacture of a medicament for increasing urine volume output in a subject with short bowel syndrome, wherein the apraglutide or a pharmaceutically acceptable salt thereof, e.g., the sodium salt thereof, is for administration to the subject in at least one therapeutically effective amount. In some embodiments, the increase in urine volume output can be at least about 400 mL / day, or at least about 500 mL / day, or at least about 600 mL / day, or at least about 700 mL / day, or at least about 800 mL / day, or at least about 900 mL / day, or at least about 1000 mL / day.

[0157] In some aspects, provided herein is a method for decreasing parenteral support volume in a subject with short bowel syndrome, the method comprising administering to the subject at least one therapeutically effective amount of apraglutide or a pharmaceutically acceptable salt thereof, e.g., the sodium salt thereof. In some aspects, provided herein is apraglutide or a pharmaceutically acceptable salt thereof, e.g., the sodium salt thereof, for use in a method of decreasing parenteral support volume in a subject with short bowel syndrome, wherein the apraglutide or a pharmaceutically acceptable salt thereof, e.g., the sodium salt thereof, is for administration to the subject in at least one therapeutically effective amount. In some aspects, provided herein is apraglutide or a pharmaceutically acceptable salt thereof, e.g., the sodium salt thereof, for use in the manufacture of a medicament for decreasing parenteral support volume in a subject with short bowel syndrome, wherein the apraglutide or a pharmaceutically acceptable salt thereof, e.g., the sodium salt thereof, is for administration to the subject in at least one therapeutically effective amount. In some embodiments, the decrease in parenteral support volume can be at least about 400 mL / day, or at least about 500 mL / day, or at least about 600 mL / day, or at least about 700 mL / day, or at least about 800 mL / day, or at least about 900 mL / day, or at least about 1000 mL / day.

[0158] In some embodiments of the preceding methods, an increase can be an increase of at least about 5%, or at least about 10%, or at least about 15%, or at least about 20%, or at least about 25%, or at least about 30%, or at least about 35%, or at least about 40%, or at least about 45%, or at least about 50%, or at least about 55%, or at least about 60%, or at least about 65%, or at least about 70%, or at least about 75%, or at least about 80%, or at least about 85%, or at least about 90%, or at least about 95%, or at least about 99%, or at least 100%, or at least 150%, or at least 200%, or at least 250%, or at least 300%, or at least 350%, or at least 400%, or at least 500%, or at least 600%, or at least 700%, or at least 800%, or at least 900?4>, or at least 1,000% as compared to a control level. In some embodiments, the control level is the amount prior to administration of the apraglutide or a pharmaceutically acceptable salt thereof, e.g., the sodium salt thereof.VECT-007 / 001WO (43765-02067)

[0159] In some embodiments of the preceding methods, a decrease is at least about 5%, or at least about 10%, or at least about 15%, or at least about 20%, or at least about 25%, or at least about 30%, or at least about 35%, or at least about 40%, or at least about 45%, or at least about 50%, or at least about 55%, or at least about 60%, or at least about 65%, or at least about 70%, or at least about 75%, or at least about 80%, or at least about 85%, or at least about 90%, or at least about 95%, or at least about 99% as compared to a control level. In some embodiments, the control level is the amount prior to administration of the apraglutide or a pharmaceutically acceptable salt thereof, e.g., the sodium salt thereof.Pharmaceutical Compositions|00160| In some aspects, the present disclosure provides a pharmaceutical composition comprising apraglutide or a pharmaceutically acceptable salt thereof, e.g., the sodium salt thereof, and a pharmaceutically acceptable adjuvant, excipient, diluent, or carrier.

[0161] In some embodiments, the pharmaceutical composition comprises a sodium salt of apraglutide.

[0162] In some embodiments, the pharmaceutical composition is a lyophilized powder.

[0163] In some embodiments, the pharmaceutical composition is a pre-lyophilization solution comprising apraglutide, or a pharmaceutically acceptable salt thereof, e.g., a sodium salt thereof, The pre-lyophilization solution may be lyophilized to form a lyophilized powder.

[0164] In some embodiments, the pharmaceutical composition is a solution (e.g., a reconstituted solution).

[0165] In some embodiments, the pharmaceutical composition comprises:a sodium salt of apraglutide;glycine;L-histidine; andmannitol,wherein glycine, L-histidine and mannitol are in a w / w ratio (as measured to the corresponding weight of the free acid of apraglutide) as follows:glycine, present at a w / w ratio of 0.15±0.05 to 1, 0.15±0.04 to 1, 0.15±0.03 to 1, 0.15±0.02 to 1, or 0.15±0.01 to 1 (e.g., about 0.15:1);L-histidine, present at a w / w ratio of 0.31±0.10 to 1, 0.31±0.05 to 1, 0.31±0.04 to 1, 0.31±0.03 to 1, 0.31±0.02 to 1, or 0.31±0.01 to 1 (e.g., about 0.31:1); andmannitol, present at a w / w ratio of 4.6±1.0 to 1, 4.6±0.5 to 1, 4.6±0.4 to 1, 4.6±0.3 to l, 4.6±0.2 to 1, or 4.6±0.1 to 1 (e.g., about 4.6: 1).VECT-007 / 001WO (43765-02067)

[0166] In some embodiments, the pharmaceutical composition comprises:a sodium salt of apraglutide;glycine;L-histidine; andmannitol,wherein glycine, L-histidine and mannitol are in a w / w ratio (as measured to the corresponding weight of the free acid of apraglutide) follows:glycine, present at a w / w ratio of about 0.15:1;L-histidine, present at a w / w ratio of about 0.31:1, andmannitol, present at a w / w ratio of about 4.6:1.|00167| In some embodiments, the pharmaceutical composition comprises:5.2+1.0 mg, 5.2+0.9 mg, 5.2+0.8 mg, 5.2+0.7 mg, 5.2+0.6 mg, 5.2+0.5 mg, 5.2+0.4 mg, 5.2+0.3 mg, 5.2+0.2 mg, or 5.2+0.1 mg (e.g., about 5,2 mg) of apraglutide (or the corresponding amount of the sodium salt of apraglutide);0.78+0.5 mg, 0.78+0.4 mg, 0.78+0.3 mg, 0.78+0.2 mg, or 0.78+0.1 mg (e.g., about 0.78 mg) of glycine;1.61+0.5 mg, 1.61+0.4 mg, 1.61+0,3 mg, 1.61+0.2 mg, or 1.61+0.1 mg (e.g., about 1,61 mg) of L-histidine; and23.92+5.0 mg, 23.92+4.0 mg, 23.92+3.0 mg, 23.92+2.0 mg, 23.92+1.0 mg, or 23.92+0.5 mg e.g., 23.92 mg) of mannitol.

[0168] In some embodiments, the pharmaceutical composition comprises:about 5.2 mg of apraglutide (or the corresponding amount of the sodium salt of apraglutide);about 0.78 mg of glycine;about 1.61 mg of L-histidine; andabout 23.92 mg of mannitol.

[0169] In some embodiments, the pharmaceutical composition comprises:about 10.4 mg of apraglutide (or the corresponding amount of the sodium salt of apraglutide);about 1.56 mg of glycine;about 3.22 mg of L-histidine; andabout 47.84 mg of mannitol.

[0170] In some embodiments, the pharmaceutical composition further comprises water (e.g., sterile water).VECT-007 / 001WO (43765-02067)

[0171] In some embodiments, the pharmaceutical composition further comprises sodium hydroxide (e.g., at an amount resulting to the pH value of the pharmaceutical composition described herein).|00172] In some embodiments, the pharmaceutical composition is a lyophilized cake which can be reconstituted in sterile water (e.g., water for injection (WFI)) prior to administration to a patient by subcutaneous injection. In some embodiments, the lyophilized cake is prepared from an aqueous solution of apraglutide, glycine, L-histidine and mannitol (pre-lyophilization solution). In some embodiments, the pre-lyophilization solution has a pH value of 8.3+1.0, 8.3+0.9, 8.3+0.8, 8.3+0.7, 8.3+0.6, 8.3+0.5, 8.3+0.3, about 8.3+0.2, 8.3+0. I (e.g., about 8.3). In some embodiments the pH of the pre-lyophilization solution is about 8.3+0.2 or 8.3+0.1 (e.g., about 8.3).

[0173] In some embodiments, the pharmaceutical composition is an aqueous solution for lyophilization comprising:about 5.2 mg of apraglutide (or the corresponding amount of the sodium salt of apraglutide);about 0.78 mg of glycine;about 1.61 mg of L-histidine; andabout 23.92 mg of mannitol,in sterile water, wherein the solution has a pH value of 8.3±1.0, 8.3±0.9, 8.3±0.8, 8.3±0.7, 8.3±0.6, 8.3±0.5, 8.3±0.3, about 8.3±0.2, 8.3±0.1 (e.g., about 8.3).

[0174] In some embodiments, the pharmaceutical composition is an aqueous solution for lyophilization comprising:about 5.4 mg of apraglutide (or the corresponding amount of the sodium salt of apraglutide);about 0.81 mg of glycine;about 1.67 mg of L-histidine; andabout 24.84 mg of mannitol,in sterile water, wherein the solution has a pH value of 8.3+1.0, 8.3+0.9, 8.3+0.8, 8.3+0.7, 8.3+0.6, 8.3+0.5, 8.3+0.3, about 8.3+0.2, 8.3+0.1 (e.g., about 8.3).

[0175] In some embodiments, the pharmaceutical composition is an aqueous solution for lyophilization comprising:about 10.4 mg of apraglutide (or the corresponding amount of the sodium salt of apraglutide);about 1.56 mg of glycine;VECT-007 / 001WO (43765-02067)about 3.22 mg of L-histidine; andabout 47.84 mg of mannitol,in sterile water, wherein the solution has a pH value of 8.3+1.0, 8.3+0.9, 8.3+0.8, 8.3+0.7, 8.3+0.6, 8.3+0.5, 8.3+0.3, about 8.3+0.2, 8.3+0.1 (e.g., about 8.3).

[0176] In some embodiments, the pH of the reconstituted solution is about 8.3+0.2 or about 8.3+0.1 (e.g., about 8.3),

[0177] In some embodiments, the sterile water is added in an amount such that the aqueous solution for lyophilization is about 1.04 ml

[0178] In some embodiments, the pharmaceutical composition is an aqueous solution for lyophilization comprising:10.0+3.0 mg / mL, 10.0+2.0 mg / mL, 10.0+1.0 mg / mL, 10.0+0.5 mg / mL, 10.0+0.3 mg, or 10.0+0.1 mg / mL (e.g., about 10.0 mg / mL) of apraglutide (or a corresponding amount of the sodium salt of apraglutide);1.5+0.5 mg / mL, 1.5+0.4 mg / mL, 1.5+0.3 mg / mL, 1.5+0.2 mg / mL, 1.5+0.1 mg / mL, or 1.5+0.05 mg / mL (e.g., about 1.5 mg / mL) of glycine,3.1+1.0 mg / mL, 3.1+0.5 mg / mL, 3.1+0.4 mg / mL, 3.1+0.3 mg / mL, 3.1+0.2 mg / mL, or 3.1+0.1 mg / mL (e.g, about 3,1 mg / mL) of L-histidine, and46.0 +15.0 mg / mL, 46.0+10.0 mg / mL, 46.0 +5.0 mg / mL, 46.0 +3.0 mg / mL, 46.0 +1.0 mg / mL, or 46.0 ±0.5 mg / mL (e.g. about 46.0 mg / mL) of mannitol,in sterile water wherein the aqueous solution has a pH of 8.3±1.0, 8.3±0.9, 8.3±0.8, 8.3+0.7, 8.3+0.6, 8.3+0.5, 8.3+0.3, about 8.3+0.2, 8.3+0.1 (e.g., about 8.3).

[0179] In some embodiments, a lyophilized cake comprising apraglutide, glycine, L-histidine, and mannitol is reconstituted in sterile water (e.g., WFI). In some embodiments, the pharmaceutical composition is a reconstituted solution comprising:21.0+21.0+5.0 mg / mL, 21.0+4.0 mg / mL, 21.0+3.0 mg / mL, 21.0+2.0 mg / mL, 21.0+1.0 mg, or 21.0+0.5 mg / mL (e.g., about 21.0 mg / mL) of apraglutide (or a corresponding amount of the sodium salt of apraglutide);3.2+1.0 mg / mL, 3.2+0.5 mg / mL, 3.2+0.4 mg / mL, 3.2+0.3 mg / mL, 3.2+0.2 mg / mL, or 3.2+0.1 mg / mL (e.g., about 3.2 mg / mL) of glycine;6.6+1.0 mg / mL, 6.6+0.5 mg / mL, 6.6+0.4 mg / mL, 6.6+0.3 mg / mL, 6.6+0.2 mg / mL, or 6.6+0.1 mg / mL (e.g., about 6.6 mg / mL) of L-histidine; and96.0+10 mg / mL, 96.0+5.0 mg / mL, 96.0+4.0 mg / mL, 96.0+3.0 mg / mL, 96.0+2.0 mg / mL, 96.0+1.0 mg, or 96.0+0.5 mg / mL (e.g., about 96.0 mg / mL) of mannitol.

[0180] In some embodiments, the pharmaceutical composition is a reconstitutedVECT-007 / 001WO (43765-02067)solution comprising:21.0+21.0+5.0 mg / mL, 21.0+4.0 mg / mL, 21.0+3.0 mg / mL, 21.0+2.0 mg / mL, 21.0+1.0 mg, or 21.0+0.5 mg / mL (e.g., about 21.0 mg / mL) of apraglutide (or a corresponding amount of the sodium salt of apraglutide);3.2+1.0 mg / mL, 3.2+0.5 mg / mL, 3.2+0.4 mg / mL, 3.2+0.3 mg / mL, 3.2+0.2 mg / mL, or 3.2±0.1 mg / mL (e.g., about 3.2 mg / mL) of glycine;6.6+1.0 mg / mL, 6.6+0.5 mg / mL, 6.6+0.4 mg / mL, 6.6+0.3 mg / mL, 6.6+0.2 mg / mL, or 6.6+0.1 mg / mL (e.g., about 6.6 mg / mL) of L-histidine; and

[0181] 95.0 to 97.0 ±10 mg / mL, 95.0 to 97.0+5.0 mg / mL, 95.0 to 97.0+4.0 mg / mL, 95.0 to 97.0+3.0 mg / mL, 95.0 to 97.0+2.0 mg / mL, 95.0 to 97.0+1.0 mg, or 95.0 to 97.0+0.5 mg / mL (e.g., about 95.0 to 97.0 mg / mL) of mannitol. In some embodiments, the pharmaceutical composition comprises:about 21.0 mg / mL of apraglutide (or a corresponding amount of the sodium salt of apraglutide);about 3.2 mg / mL of glycine;about 6.6 mg / mL of L-histidine; andabout 96.0 mg / mL of mannitol.

[0182] In some embodiments, the pharmaceutical composition has a pH value of 8.3+1.0, 8.3+0.9, 8.3+0.8, 8.3+0.7, 8.3+0.6, 8.3+0.5, 8.3+0.3, about 8.3+0.2, 8.3+0.1 (e.g., about 8.3); and the pharmaceutical composition comprises:21.0+5.0 mg / mL, 21.0+4.0 mg / mL, 21.0+3.0 mg / mL, 21.0+2.0 mg / mL, 21.0+1.0 mg, or 21.0+0.5 mg / mL (e.g., about 21.0 mg / mL) of apraglutide (or a corresponding amount of the sodium salt of apraglutide);3.2+1.0 mg / mL, 3.2±0.5 mg / mL, 3.2±0.4 mg / mL, 3.2±0.3 mg / mL, 3.2±0.2 mg / mL, or 3.2±0.1 mg / mL (e.g., about 3.2 mg / mL) of glycine;6.6±1.0 mg / mL, 6.6±0.5 mg / mL, 6.6±0.4 mg / mL, 6.6±0.3 mg / mL, 6.6±0.2 mg / mL, or 6.6±0.1 mg / mL (e.g., about 6.6 mg / mL) of L-histidine; and96.0+10 mg / mL, 96.0+5.0 mg / mL, 96.0+4.0 mg / mL, about 96.0+3.0 mg / mL, 96.0+2.0 mg / mL, 96.0+1.0 mg, or 96.0+0.5 mg / mL (e.g., about 96.0 mg / mL) of mannitol.

[0183] In some embodiments, the pharmaceutical composition has a pH value of about 8.3; and the pharmaceutical composition comprises:about 21.0 mg / mL of apraglutide (or a corresponding amount of the sodium salt of apraglutide);about 3.2 mg / mL of glycine;VECT-007 / 001WO (43765-02067)about 6.6 mg / mL of L-histidine; andabout 96.0 mg / mL of mannitol.

[0184] In some embodiments, the apraglutide or a pharmaceutically acceptable salt thereof, e.g., the sodium salt thereof, has a purity of no less than 90.0%, no less than 91.0%, no less than 92.0%, no less than 93.0%, no less than 94.0%, no less than 95.0%, no less than 96.0%, no less than 97.0%, no less than 98.0%, no less than 99.0%, no less than 99.5%, no less than 99.6%, no less than 99.7%, no less than 99.8%, or no less than 99.9%.

[0185] In some embodiments, the apraglutide or a pharmaceutically acceptable salt thereof, e.g., the sodium salt thereof, has a purity of no less than 94.0%.

[0186] In some embodiments, the apraglutide or a pharmaceutically acceptable salt thereof, e.g., the sodium salt thereof, has a purity of no less than 95.0%.

[0187] In some embodiments, the apraglutide or a pharmaceutically acceptable salt thereof, e.g., the sodium salt thereof, has a purity of no less than 97.0%.

[0188] Without wishing to be bound by theory, it is understood that apraglutide impurities may include, without limitation, Des-Gly4, Aspartimide3, Asp33-OH, Des-Ser7, D-Asp3, β-Asp3, and / or D-His1. The apraglutide impurities may further include other unspecified impurities.

[0189] In some embodiments, the amount and / or presence of Des-Gly4, Aspartimide3, Asp33-OH, Des-Ser7, D-Asp3, β-Asp3, and D-His1, as apraglutide impurities, are determined using reverse phase high performance liquid chromatography (RP-HPLC). In some embodiments, the Des-Gly4and Aspartimide3are detected in a single peak of the RP-HPLC chromatogram.

[0190] In some embodiments, the apraglutide or a pharmaceutically acceptable salt thereof, e.g., the sodium salt thereof, does not contain Des-Gly4plus Aspartimide3at a total amount greater than 0.01%, greater than 0.05%, greater than 0.1%, greater than 0.5%, greater than 1.0%, greater than 1.5%, greater than 2.0%. or greater than 2.5%. in some embodiments, the apraglutide or a pharmaceutically acceptable salt thereof, e.g., the sodium salt thereof, does not contain Des-Gly4plus Aspartimide3at a total amount greater than 2,5%. In some embodiments, the apraglutide or a pharmaceutically acceptable salt thereof, e.g., the sodium salt thereof, does not contain Des-Gly4plus Aspartimide3at a total amount greater than 2.0%. In some embodiments, the apraglutide or a pharmaceutically acceptable salt thereof, e.g., the sodium salt thereof, does not contain Des-Gly4plus Aspartimide3at a total amount greater than 1.5%. In some embodiments, the apraglutide or a pharmaceutically acceptable salt thereof, e.g., the sodium salt thereof, does not contain Des-Gly4plus Aspartimide3at a total amount greaterVECT-007 / 001WO (43765-02067)than 1.0%.

[0191] In some embodiments, the apraglutide or a pharmaceutically acceptable salt thereof, e.g., the sodium salt thereof, does not contain Asp33-OH at an amount greater than 0.01%, greater than 0.05%, greater than 0.1%, greater than 0.5%, greater than 1.0%, greater than 1.5%, or greater than 2.0%. In some embodiments, the apraglutide or a pharmaceutically acceptable salt thereof, e.g., the sodium salt thereof, does not contain Asp33-OH at an amount greater than 2.0%. In some embodiments, the apraglutide or a pharmaceutically acceptable salt thereof, e.g., the sodium salt thereof, does not contain Asp33-OH at an amount greater than 1.5%. In some embodiments, the apraglutide or a pharmaceutically acceptable salt thereof, e.g., the sodium salt thereof, does not contain Asp33-OH at an amount greater than 1.0%.

[0192] In some embodiments, the apraglutide or a pharmaceutically acceptable salt thereof, e.g., the sodium salt thereof, does not contain Des-Ser7at an amount greater than 0.01%, greater than 0.05%, greater than 0.1%, greater than 0.5%, greater than 1.0%, greater than 1.5%, or greater than 2.0%. In some embodiments, the apraglutide or a pharmaceutically acceptable salt thereof, e.g., the sodium salt thereof, does not contain Des-Ser7at an amount greater than 1.0%. In some embodiments, the apraglutide or a pharmaceutically acceptable salt thereof, e.g., the sodium salt thereof, does not contain Des-Ser7at an amount greater than 0.5%

[0193] In some embodiments, the apraglutide or a pharmaceutically acceptable salt thereof, e.g., the sodium salt thereof, does not contain D-Asp3at an amount greater than 0.01%, greater than 0.05%, greater than 0.1%, greater than 0.5%, greater than 1.0%, greaterthan 1.5%, or greater than 2.0%. In some embodiments, the apraglutide or a pharmaceutically acceptable salt thereof, e.g., the sodium salt thereof, does not contain D-Asp3at an amount greater than 1.5%. In some embodiments, the apraglutide or a pharmaceutically acceptable salt thereof, e.g., the sodium salt thereof, does not contain D-Asp3at an amount greater than 1.0%. In some embodiments, the apraglutide or a pharmaceutically acceptable salt thereof, e.g., the sodium salt thereof, does not contain D-Asp3at an amount greater than 0.5%.

[0194] In some embodiments, the apraglutide or a pharmaceutically acceptable salt thereof, e.g., the sodium salt thereof, does not contain β-Asp3at an amount greater than 0.01%, greater than 0.05%, greater than 0.1%, greater than 0.5%, greater than 1.0%, greater than 1.5%, greater than 2.0%, greater than 2.5%, or greater than 3.0%. In some embodiments, the apraglutide or a pharmaceutically acceptable salt thereof, e.g., the sodium salt thereof, does not contain β-Asp3at an amount greater than 3.0%. In some embodiments, the apraglutide or a pharmaceutically acceptable salt thereof, e.g., the sodium salt thereof, does not contain β-Asp3at an amount greater than 2.0%. In some embodiments, the apraglutide or a pharmaceuticallyVECT-007 / 001WO (43765-02067)acceptable salt thereof, e.g., the sodium salt thereof, does not contain p-Asp3at an amount greater than 1.5%.

[0195] In some embodiments, apraglutide, or a pharmaceutically acceptable salt thereof, e.g., the sodium salt thereof, does not contain D-His1in an amount greater than 0.01%, greater than 0.05%, greater than 0.1%, greater than 0.5%, greater than 1.0%, greater than 1.2%, greater than 1.5%, or greater than 2.0%. In some embodiments, apraglutide, or a pharmaceutically acceptable salt thereof, e.g., the sodium salt thereof, does not contain D-His1in an amount greater than 2.0%. In some embodiments, apraglutide, or a pharmaceutically acceptable salt thereof, e.g., the sodium salt thereof, does not contain D-His1in an amount greater than 1.5%. In some embodiments, apraglutide, or a pharmaceutically acceptable salt thereof, e.g., the sodium salt thereof, does not contain D-His1in an amount greater than 1.2%. In some embodiments, apraglutide, or a pharmaceutically acceptable salt thereof, e.g., the sodium salt thereof, does not contain D-His1in an amount greater than 0.5%.

[0196] In some embodiments, the apraglutide or a pharmaceutically acceptable salt thereof, e.g., the sodium salt thereof, does not contain any unspecified impurity at an amount greater than 0.01%, greater than 0.05%, greater than 0.1%. greater than 0.5%, greater than 1,0%, greater than 1.5%, greater than 2.0%, greater than 2.5%, or greater than 3.0%, In some embodiments, the apraglutide or a pharmaceutically acceptable salt thereof, e.g., the sodium salt thereof, does not contain any unspecified impurity at an amount greater than 1.0%. In some embodiments, the apraglutide or a pharmaceutically acceptable salt thereof, e.g., the sodium salt thereof, does not contain any unspecified impurity at an amount greater than 0.5%. In some embodiments, the apraglutide or a pharmaceutically acceptable salt thereof, e.g., the sodium salt thereof, does not contain any unspecified impurity at an amount greater than 0.1%.

[0197] In some embodiments, the apraglutide or a pharmaceutically acceptable salt thereof, e.g., the sodium salt thereof, does not contain Des-Gly4plus Aspartimide3at a total amount greater than 2.0%, does not contain Asp33-OH at an amount greater than 1.5%, does not contain Des-Ser7at an amount greater than 1.0%, does not contain D-Asp3at an amount greater than 1.0%, does not contain β-Asp3at an amount greater than 2.0%, and does not contain D-His1at an amount greater than 1.2%.

[0198] In some embodiments, the apraglutide or a pharmaceutically acceptable salt thereof, e.g., the sodium salt thereof, does not contain Des-Gly4plus Aspartimide3at a total amount greater than 2.0%, does not contain Asp33-OH at an amount greater than 1.5%, does not contain Des-Ser7at an amount greater than 1.0%, does not contain D-Asp3at an amount greater than 1.0%, does not contain β-Asp3at an amount greater than 2.0%, does not containVECT-007 / 001WO (43765-02067)D-His1at an amount greater than 1.2%, and does not contain any unspecified impurity at an amount greater than 0.5%.

[0199] In some embodiments, the apraglutide or a pharmaceutically acceptable salt thereof, e.g., the sodium salt thereof, has a purity of no less than 94.0%, and the apraglutide or a pharmaceutically acceptable salt thereof, e.g., the sodium salt thereof, does not contain Des-Gly4plus Aspartimide3at a total amount greater than 2.0%, does not contain Asp33-OH at an amount greater than 1.5%, does not contain Des-Ser7at an amount greater than 1.0%, does not contain D-Asp3at an amount greater than 1.0%, does not contain β-Asp3at an amount greater than 2.0%, does not contain D-His1at an amount greater than 1.2%, and does not contain any unspecified impurity at an amount greater than 0.5%.

[0200] In some embodiments, the apraglutide or a pharmaceutically acceptable salt thereof, e.g., the sodium salt thereof, does not contain Des-Gly4plus Aspartimide3at a total amount greater than 1.0%, does not contain Asp33-OH at an amount greater than 1.0%, does not contain Des-Ser7at an amount greater than 0.5%, does not contain D-Asp3at an amount greater than 1.0%, does not contain β-Asp3at an amount greater than 1.5%, and does not contain D-His1at an amount greater than 0.5%.

[0201] In some embodiments, the apraglutide or a pharmaceutically acceptable salt thereof, e.g., the sodium salt thereof, does not contain Des-Gly4plus Aspartimide3at a total amount greater than 1.0%, does not contain Asp33-OH at an amount greater than 1.0%, does not contain Des-Ser7at an amount greater than 0.5%, does not contain D-Asp3at an amount greater than 1.0%, does not contain β-Asp3at an amount greater than 1.5%, does not contain D-His1at an amount greater than 0.5%, and does not contain any unspecified impurity at an amount greater than 0.5%.

[0202] In some embodiments, the apraglutide or a pharmaceutically acceptable salt thereof, e.g., the sodium salt thereof, has a purity of no less than 97.0%, and the apraglutide or a pharmaceutically acceptable salt thereof, e.g., the sodium salt thereof, does not contain Des-Gly4plus Aspartimide3at a total amount greater than 1.0%, does not contain Asp33-OH at an amount greater than 1.0%, does not contain Des-Ser7at an amount greater than 0.5%, does not contain D-Asp3at an amount greater than 1.0%, does not contain β-Asp3at an amount greater than 1.5%, does not contain D-His1at an amount greater than 0.5%, and does not contain any unspecified impurity at an amount greater than 0.5%.

[0203] In some embodiments, apraglutide, or a pharmaceutically acceptable salt thereof, e.g., the sodium salt thereof, in the pharmaceutical composition does not contain bacterial endotoxins at a concentration greater than 1.0, 2.5, 5.0, 7.5, or 10.0 EU / mg. In someVECT-007 / 001WO (43765-02067)embodiments, the purified apraglutide, or a pharmaceutically acceptable salt thereof, e.g., the sodium salt thereof, does not contain bacterial endotoxins at a concentration greater than about 5.0 EU / mg.

[0204] In some embodiments, a pharmaceutical composition comprising apraglutide, or a pharmaceutically acceptable salt thereof, e.g., the sodium salt thereof, does not contain Des-Gly4plus Aspartimide3at a total amount greater than 0,01%, greater than 0.05%, greater than 0.1%, greater than 0,5%, greater than 1.0%, greater than 1.5%, greater than 2.0%, greater than 2.5%, or greater than 3.0%. In some embodiments, the pharmaceutical composition comprising apraglutide, or a pharmaceutically acceptable salt thereof, e.g., the sodium salt thereof, does not contain Des-Gly4plus Aspartimide3in an amount greater than 3,0%. In some embodiments, the pharmaceutical composition comprising apraglutide, or a pharmaceutically acceptable salt thereof, e.g., the sodium salt thereof, does not contain Des-Gly4plus Aspartimide3in an amount greater than 2.5%. In some embodiments, the pharmaceutical composition comprising apraglutide, or a pharmaceutically acceptable salt thereof, e.g., the sodium salt thereof, does not contain Des-Gly4plus Aspartimide3at a total amount greater than 2.0%.

[0205] In some embodiments, the pharmaceutical composition comprising apraglutide, or a pharmaceutically acceptable salt thereof, e.g., the sodium salt thereof, does not contain Asp33-OH in an amount greater than 0.01%, greater than 0.05%, greater than 0.1%, greater than 0,5%, greater than 1.0%, greater than 1.5%, greater than 2.0%, or greater than 2.5%. In some embodiments, the pharmaceutical composition comprising apraglutide, or a pharmaceutically acceptable salt thereof, e.g., the sodium salt thereof, does not contain Asp33-OH in an amount greater than 2.5%. In some embodiments, the pharmaceutical composition comprising apraglutide, or a pharmaceutically acceptable salt thereof, e.g., the sodium salt thereof, does not contain Asp33-OH in an amount greater than 2.0%. In some embodiments, the pharmaceutical composition comprising apraglutide, or a pharmaceutically acceptable salt thereof, e.g., the sodium salt thereof, does not contain Asp33-OH in an amount greater than 1.5%.

[0206] In some embodiments, the pharmaceutical composition comprising apraglutide, or a pharmaceutically acceptable salt thereof, e.g., the sodium salt thereof, does not contain Des-Ser7plus aspartimide33in an amount greater than 0.01%, greater than 0.05%, greater than 0.1%, greater than 0.5%, greater than 1.0%, greater than 1.5%, or greater than 2.0%. In some embodiments, the pharmaceutical composition comprising apraglutide, or a pharmaceutically acceptable salt thereof, e.g., the sodium salt thereof, does not contain Des-Ser7plusVECT-007 / 001WO (43765-02067)aspartimide33in an amount greater than 1.5%. In some embodiments, the pharmaceutical composition comprising apraglutide, or a pharmaceutically acceptable salt thereof, e.g., the sodium salt thereof, does not contain Des-Ser7plus aspartimide33in an amount greater than 1.0%. In some embodiments, the pharmaceutical composition comprising apraglutide, or a pharmaceutically acceptable salt thereof, e.g., the sodium salt thereof, does not contain Des-Ser7plus aspartimide33in an amount greater than 0.5%.

[0207] In some embodiments, the pharmaceutical composition comprising apraglutide, or a pharmaceutically acceptable salt thereof, e.g., the sodium salt thereof, does not contain D-Asp3in an amount greater than 0.01%, greater than 0.05%, greater than 0.1%, greater than 0,5%, greater than 1.0%, greater than 1.5%, or greater than 2.0%. In some embodiments, the pharmaceutical composition comprising apraglutide, or a pharmaceutically acceptable salt thereof, e.g., the sodium salt thereof, does not contain D-Asp3in an amount greater than 1.5%. In some embodiments, the pharmaceutical composition comprising apraglutide, or a pharmaceutically acceptable salt thereof, e.g., the sodium salt thereof, does not contain D-Asp3in an amount greater than 1.0%. In some embodiments, the pharmaceutical composition comprising apraglutide, or a pharmaceutically acceptable salt thereof, e.g., the sodium salt thereof, does not contain D-Asp3in an amount greater than 0.5%.

[0208] In some embodiments, the pharmaceutical composition comprising apraglutide, or a pharmaceutically acceptable salt thereof, e.g., the sodium salt thereof, does not contain β-Asp3in an amount greater than 0.01%, greater than 0.05%, greater than 0.1%, greater than 0.5%. greater than 1.0%, greater than 1.5%, greater than 2.0%, greater than 2.5%, greater than 3.0%, greater than 3.5%, or greater than 4.0%. In some embodiments, the pharmaceutical composition comprising apraglutide, or a pharmaceutically acceptable salt thereof, e.g., the sodium salt thereof, does not contain β-Asp3in an amount greater than 3.5%. In some embodiments, the pharmaceutical composition comprising apraglutide, or a pharmaceutically acceptable salt thereof, e.g., the sodium salt thereof, does not contain β-Asp3in an amount greater than 3.0%. In some embodiments, the pharmaceutical composition comprising apraglutide, or a pharmaceutically acceptable salt thereof, e.g., the sodium salt thereof, does not contain β-Asp3in an amount greater than 2.0%.

[0209] In some embodiments, the pharmaceutical composition comprising apraglutide, or a pharmaceutically acceptable salt thereof, e.g., the sodium salt thereof, does not contain bacterial endotoxins at a concentration greater than 5.0, 10.0, 15.0, 20.0, 25.0, or 30.0 EU / mg. in some embodiments, the pharmaceutical composition comprising apraglutide, or a pharmaceutically acceptable salt thereof, e.g., the sodium salt thereof, does not containVECT-007 / 001WO (43765-02067)bacterial endotoxins at a concentration greater than about 25 EU / mg.

[0210] In some embodiments, the pharmaceutical composition comprising apraglutide, or a pharmaceutically acceptable salt thereof, e.g., the sodium salt thereof, does not contain any unspecified impurity in an amount greater than 0.01%, greater than 0.05%, greater than 0.1%, greater than 0.5%, greater than 1%, greater than 1.5%, or greater than 2.0%. In some embodiments, the pharmaceutical composition comprising apraglutide, or a pharmaceutically acceptable salt thereof, e.g., the sodium salt thereof, does not contain any unspecified impurity in an amount greater than 1.0%. In some embodiments, the pharmaceutical composition comprising apraglutide, or a pharmaceutically acceptable salt thereof, e.g., the sodium salt thereof, does not contain any unspecified impurity in an amount greater than 0.5%. In some embodiments, the pharmaceutical composition comprising apraglutide, or a pharmaceutically acceptable salt thereof, e.g., the sodium salt thereof, does not contain any unspecified impurity in an amount greater than 0.2%.

[0211] In some embodiments, the pharmaceutical composition comprising apraglutide, or a pharmaceutically acceptable salt thereof, e.g., the sodium salt thereof, does not contain Des-Gly4plus Aspartimide3in an amount greater than 2.5%, does not contain Asp33-OH in an amount greater than 2.0%, does not contain Des-Ser7plus aspartimide33in an amount greater than 1.0%, does not contain D-Asp3in an amount greater than 1.0%, and does not contain β-Asp3in an amount greater than 3.0%.

[0212] In some embodiments, the pharmaceutical composition comprising apraglutide, or a pharmaceutically acceptable salt thereof, e.g., the sodium salt thereof, does not contain Des-Gly4plus Aspartimide3at a total amount greater than 2.5%, does not contain Asp33-OH in an amount greater than 2.0%, does not contain Des-Ser7plus aspartimide33in an amount greater than 1.0%, does not contain D-Asp3in an amount greater than 1,0%, does not contain β-Asp3in an amount greater than 3.0%, and does not contain any unspecified impurity in an amount greater than 0.5%.

[0213] In some embodiments, the pharmaceutical composition comprising apraglutide or a pharmaceutically acceptable salt thereof, e.g., the sodium salt thereof, has a purity of no less than 94.0%, and the pharmaceutical composition, does not contain Des-Gly4plus Aspartimide3in a total amount greater than 2.5%, does not contain Asp33-OH in an amount greater than 2.0%, does not contain Des-Ser7plus aspartimide33in an amount greater than 1.0%, does not contain D-Asp3in an amount greater than 1.0%, does not contain β-Asp3in an amount greater than 3.0%, and does not contain any unspecified impurity in an amount greater than 0.5%.VECT-007 / 001WO (43765-02067)

[0214] In some embodiments, the pharmaceutical composition comprising apraglutide or a pharmaceutically acceptable salt thereof, e.g., the sodium salt thereof, does not contain Des-Gly4plus Aspartimide3in a total amount greater than 1.5%, does not contain Asp33-OH in an amount greater than 1.5%, does not contain Des-Ser7plus aspartimide33in an amount greater than 1.0%, does not contain D-Asp3in an amount greater than 1.0%, and does not contain P~ Asp3in an amount greater than 2.0%

[0215] In some embodiments, the pharmaceutical composition comprising apraglutide or a pharmaceutically acceptable salt thereof, e.g., the sodium salt thereof, does not contain Des-Gly4plus Aspartimide3in a total amount greater than 1.5%, does not contain Asp33-OH in an amount greater than 1.5%, does not contain Des-Ser7plus aspartimide33in an amount greater than 1.0, does not contain D-Asp3in an amount greater than 1.0%, does not contain p-Asp3in an amount greater than 2.0%, and does not contain any unspecified impurity in an amount greater than 0,5%,

[0216] In some embodiments, the pharmaceutical composition comprising apraglutide or a pharmaceutically acceptable salt thereof, e.g., the sodium salt thereof, has a purity of no less than 95.0%, and the pharmaceutical composition does not contain Des-Gly4plus Aspartimide3in a total amount greater than 2.5%, does not contain Asp33-OH in an amount greater than 2.0%, does not contain Des-Ser' plus aspartimide33in an amount greater than 1.0%, does not contain D-Asp3in an amount greater than 1.0%, does not contain β-Asp3in an amount greater than 3.0%, and does not contain any unspecified impurity in an amount greater than 0.5%.

[0217] In some embodiments, the pharmaceutical composition comprising apraglutide or a pharmaceutically acceptable salt thereof, e.g., the sodium salt thereof, has a purity of no less than 97.0%, and the pharmaceutical composition does not contain Des-Gly4plus Aspartimide3in a total amount greater than 1.5%, does not contain Asp33-OH in an amount greater than 1.5%, does not contain Des-Ser7plus aspartimide33in an amount greater than 1.0%, does not contain D-Asp3in an amount greater than 1.0%, does not contain β-Asp3in an amount greater than 2.0%, and does not contain any unspecified impurity in an amount greater than 0.5%.

[0218] In some embodiments, the pharmaceutical composition comprises apraglutide, or a pharmaceutically acceptable salt thereof, e.g., the sodium salt thereof, substantially free from visible particulates. In some embodiments, the pharmaceutical composition comprises sub visible particles in a range of 2 to 10 pm. In some embodiments, the pharmaceutical composition comprises subvisible particles >10 pm in an amount less than or equal to 6,000VECT-007 / 001 WO (43765-02067)particles / vial, e.g., less than or equal to 5,000 particles / vial, less than or equal to 4,000 particles / vial, less than or equal to 3,000 particles / vial, less than or equal to 2,000 particles / vial, less than or equal to 1,000 particles / vial, or less than or equal to 500 particles / vial. In some embodiments, the pharmaceutical composition comprises subvisible particles >25 pm in an amount less than or equal to 600 particles / vial, e.g., less than or equal to 500 particles / vial, less than or equal to 400 particles / vial, less than or equal to 300 particles / vial, less than or equal to 200 particles / vial, less than or equal to 100 particles / vial, or less than or equal to 50 particles / vial.

[0219] In some embodiments, tire pharmaceutical composition is sterile, i.e., absent of microbial growth.

[0220] In some embodiments, a pharmaceutical composition comprising purified apraglutide, or a pharmaceutically acceptable salt thereof, e.g., the sodium salt thereof, does not contain bacterial endotoxins at a concentration greater than 5,0, 10.0, 15.0, 20.0, 25.0, or 30.0 EU / mg apraglutide. In some embodiments, a pharmaceutical composition comprising apraglutide, or a pharmaceutically acceptable salt thereof, e.g., the sodium salt thereof, does not contain bacterial endotoxins at a concentration greater than 25 EU / mg apraglutide.

[0221] Suitable pharmaceutically acceptable carriers include those typically used with peptide— based drugs. See, e.g., " Remington: The Science and Practice of Pharmacy," 22nd ed., Pharmaceutical Press, Philadelphia, PA, 2012, for general guidance on drug formulations. Non-limiting examples of suitable excipients include glycine, L-histidine, mannitol, and any combination thereof.

[0222] An exemplary pharmaceutical composition of the present disclosure uses glycine as a buffering agent. L-Histidine is used in this formulation as a physically stabilizing agent. L-Histidine also serves as a buffer, maintaining the target pH. Mannitol is used in this formulation as a bulking agent in the lyophilization process step. Sterile water (e.g., WFI) is the solvent of this formulation; the sterile water is removed during the lyophilization step.

[0223] Sodium hydroxide is used for pH adjustment. pH is measured and may be adjusted to about pH 8.3 with sodium hydroxide (NaOH) solution.

[0224] In some aspects, the present disclosure provides a robust and reproducible lyophilization cycle for the manufacture of the drug product. Using the same container closure intended to be used in the manufacture of the clinical batch, two scaled down development batches were filled. The lyophilization cycle was optimized for primary' dry ing (primary dry ing cycle) to define the process to be implemented in clinical manufacturing of the drug product. The optimized lyophilization cycle resulted in a drug product with the expected qualityVECT-007 / 001WO (43765-02067)attributes (i.e., assay, purity and impurity levels, reconstitution time and moisture content) and was deemed appropriate for a clinical batch of the drug product. A stability study demonstrated the drug product remained unchanged at the intended storage temperature (5 + 3°C) for up to 48 months.

[0225] In some embodiments, the pharmaceutical composition comprises glycine, L-histidine, mannitol, water for injection (WFI), sodium hydroxide, or any combination thereof.

[0226] In some embodiments, the pharmaceutical composition comprises glycine, L-histidine, mannitol, sterile water for injection (sWFI), sodium hydroxide, or any combination thereof.

[0227] In some embodiments, the pharmaceutical composition comprises the sodium salt of apraglutide, The weight of apraglutide in formulation herein is the weight of apraglutide without counterions. In some embodiments, the sodium salt of apraglutide has three sodium counterions and the weight of the sodium salt of apraglutide can be calculated from the corresponding weight of the free acid of apraglutide given herein. Alternatively, when the sodium salt of apraglutide is used to prepare the pre-lyophilization solution, the amount of the free acid of apraglutide can be determined by HPLC by comparing the pre-lyophilization solution to a reference standard of apraglutide. In some embodiments, tire pharmaceutical composition comprises between about 4.7 mg and about 5.7 mg of the free acid of apraglutide, or the corresponding amount of the sodium salt, per vial. In some embodiments, the pharmaceutical composition comprises about 4.5 mg, about 4.6 mg, about 4.7 mg, about 4.8 mg, about 4.9 mg, about 5.0 mg, about 5.1 mg, about 5.2. mg, about 5.3 mg, about 5.4 mg, about 5,5 mg, about 5.6 mg, about 5.7 mg, or about 5.8 mg of the free acid of apraglutide, or the corresponding amount of the sodium salt. In some embodiments, the pharmaceutical composition comprises about 5.2. mg of the free acid of apraglutide, or the corresponding amount of the sodium salt.

[0228] In some embodiments, the pharmaceutical composition comprises between about 4.4 mg and about 6.4 mg of the free acid of apraglutide, or the corresponding amount of the sodium salt, per vial. In some embodiments, the pharmaceutical composition comprises about 4.4 mg, about 4.6 mg, about 4.8 mg, about 5.0 mg, about 5,2 mg, about 5,3 mg, about 5.4 mg, about 5.5 mg, about 5.6 mg, about 5.8 mg, about 6.0 mg, about 6.2 mg, or about 6.4 mg of the free acid of apraglutide, or the corresponding amount of the sodium salt. In some embodiments, the pharmaceutical composition comprises about 5.4 mg of the free acid of apraglutide, or the corresponding amount of the sodium salt.

[0229] In some embodiments, the pharmaceutical composition comprises betweenVECT-007 / 001WO (43765-02067)about 0.70 mg and about 0.85 mg glycine, per vial. In some embodiments, the pharmaceutical composition comprises between about 0.72 mg and about 0.83 mg glycine, per vial. In some embodiments, the pharmaceutical composition comprises between about 0.74 mg and about 0.82 mg glycine, per vial. In some embodiments, the pharmaceutical composition comprises between about 0.75 mg and about 0.81 mg glycine, per vial. In some embodiments, the pharmaceutical composition comprises about 0,70 mg, about 0.71 mg, about 0.72 mg, about 0.73 mg, about 0.74 mg, about 0.75 mg, about 0.76 mg, about 0.77 mg, about 0.78 mg, about 0.79 mg, about 0.80 mg, about 0.81 mg, about 0.82 mg, about 0.83 mg, about 0.84 mg, or about 0.85 mg glycine, per vial. In some embodiments, the pharmaceutical composition comprises about 0.78 mg glycine, per vial.

[0230] In some embodiments, the pharmaceutical composition comprises between about 0.75 mg and about 0.87 mg glycine, per vial. In some embodiments, the pharmaceutical composition comprises between about 0.77 mg and about 0.85 mg glycine, per vial. In some embodiments, the pharmaceutical composition comprises between about 0.79 mg and about 0.83 mg glycine, per vial. In some embodiments, the pharmaceutical composition comprises about 0.75 mg, about 0.76 mg, about 0.77 mg, about 0.78 mg, about 0.79 mg, about 0.80 mg, about 0.81 mg, about 0.82 mg, about 0.83 mg, about 0.84 mg, about 0.85 mg, about 0.86 mg, or about 0.87 mg glycine, per vial. In some embodiments, the pharmaceutical composition comprises about 0.81 mg glycine, per vial.

[0231] In some embodiments, the pharmaceutical composition comprises between about 1.51 mg and about 1.71 mg L-Histidine, per vial. In some embodiments, the pharmaceutical composition comprises between about 1.56 mg and about 1.66 mg L-Histidine, per vial. In some embodiments, the pharmaceutical composition comprises between about 1.58 mg and about 1.64 mg L-Histidine, per vial. In some embodiments, the pharmaceutical composition comprises about 1.51 mg, about 1.52 mg, about 1.53 mg, about 1.54 mg, about 1.55 mg, about 1.56 mg, about 1.57 mg, about 1.58 mg, about 1.59 mg, about 1.60 mg, about 1.61 mg, about 1.62 mg, about 1.63 mg, about 1.64 mg, about 1.65 mg, about 1.66 mg, about 1.67 mg, about 1.68 mg, about 1.69 mg, about 1.70 mg, or about 1.71 mg L-Histidine, per vial. In some embodiments, the pharmaceutical composition comprises about 1.61 mg L-Histidine, per vial.

[0232] In some embodiments, the pharmaceutical composition comprises between about 1.61 mg and about 1.73 mg L-Histidine, per vial. In some embodiments, the pharmaceutical composition comprises between about 1.63 mg and about 1.71 mg L-Histidine, per vial. In some embodiments, the pharmaceutical composition comprises between aboutVECT-007 / 001WO (43765-02067)1.65 mg and about 1.69 mg L-Histidine, per vial. In some embodiments, the pharmaceutical composition comprises about 1.61 mg, about 1.62 mg, about 1.63 mg, about 1.64 mg, about 1.65 mg, about 1.66 mg, about 1.67 mg, about 1.68 mg, about 1.69 mg, about 1.70 mg, about 1.71 mg, about 1.72 mg, or about 1.73 mg L-Histidine, per vial. In some embodiments, the pharmaceutical composition comprises about 1.67 mg L-Histidine, per vial.

[0233] In some embodiments, the pharmaceutical composition comprises between about 22.92 mg and about 24.92 mg mannitol, per vial. In some embodiments, the pharmaceutical composition comprises between about 23.42 mg and about 24.42 mg mannitol, per vial. In some embodiments, the pharmaceutical composition comprises between about 23.72 mg and about 24.12 mg mannitol, per vial. In some embodiments, the pharmaceutical composition comprises about 22.92 mg, about 23.02 mg, about 23.12 mg, about 23.22 mg, about 23.32 mg, about 23.42 mg, about 23.52 mg, about 23.62 mg, about 23.72 mg, about 23.82 mg, about 23.92 mg, about 24.02 mg, about 24.12 mg, about 24.22 mg, about 24.32 mg, about 24.42 mg, about 24.52 mg, about 24.62 mg, about 24.72 mg, about 24.82 mg, or about 24.92 mg mannitol, per vial. In some embodiments, the pharmaceutical composition comprises about 23.92 mg mannitol, per vial.

[0234] In some embodiments, the pharmaceutical composition comprises between about 23.84 mg and about 25.84 mg mannitol, per vial. In some embodiments, the pharmaceutical composition comprises between about 24.24 mg and about 25.44 mg mannitol, per vial. In some embodiments, the pharmaceutical composition comprises between about 24.54 mg and about 25.14 mg mannitol, per vial. In some embodiments, the pharmaceutical composition comprises about 23.84 mg, about 23.94 mg, about 24.04 mg, about 24.14 mg, about 24.24 mg, about 24.34 mg, about 24.44 mg, about 24.54 mg, about 24.64 mg, about 24.74 mg, about 24.84 mg, about 24.94 mg, about 25.04 mg, about 25.14 mg, about 25.24 mg, about 25.34 mg, about 25.44 mg, about 25.54 mg, about 25.64 mg, about 25.74 mg, or about 25.84 mg mannitol, per vial. In some embodiments, the pharmaceutical composition comprises about 24.84 mg mannitol, per vial,

[0235] In some embodiments, the pharmaceutical composition comprises between about 9.4 mg and about 11.4 mg of apraglutide, or the corresponding amount of the sodium salt, per vial. In some embodiments, the pharmaceutical composition comprises between about 9.4 mg and about 11.5 mg of apraglutide, or the corresponding amount of the sodium salt. In some embodiments, the pharmaceutical composition comprises about 9.4 mg, about 9.5 mg, about 9.6 mg, about 9.7 mg, about 9.8 mg, about 9.9 mg, about 10.0 mg, about 10.1 mg, about 10.2 mg, about 10.3 mg, about 10.4 mg, about 10.5 mg, about 10.6 mg, about 10.7 mg, aboutVECT-007 / 001WO (43765-02067)10.8 mg, about 10.9 mg, about 11.0 mg, about 11.1 mg, about 11.2 mg, about 11.3 mg, about 11.4 mg, or about 11.5 mg of apraglutide, or the corresponding amount of the sodium salt. In some embodiments, the pharmaceutical composition comprises about 10.4 mg of the free acid of apraglutide, or the corresponding amount of the sodium salt.

[0236] In some embodiments, the pharmaceutical composition comprises between about 1.46 mg and about 1.66 mg glycine, per vial. In some embodiments, the pharmaceutical composition comprises between about 1.51 mg and about 1.61 mg glycine, per vial. In some embodiments, the pharmaceutical composition comprises between about 1.53 mg and about 1.59 mg glycine, per vial. In some embodiments, the pharmaceutical composition comprises about 1.46 mg, about 1.47 mg, about 1.48 mg, about 1.49 mg, about 1.50 mg, about 1.51 mg, about 1.52 mg, about 1.53 mg, about 1.54 mg, about 1.55 mg, about 1.56 mg, about 1.57 mg, about 1.58 mg, about 1.59 mg, about 1.60 mg, about 1.61 mg, about 1.62 mg, about 1.63 mg, about 1.64 mg, about 1.65 mg, or about 1.66 mg glycine, per vial. In some embodiments, the pharmaceutical composition comprises about 1.56 mg glycine, per vial.

[0237] In some embodiments, the pharmaceutical composition comprises between about 3.12 mg and about 3.32 mg L-Histidine, per vial. In some embodiments, the pharmaceutical composition comprises between about 3.17 mg and about 3.27 mg L-Histidine, per vial. In some embodiments, the pharmaceutical composition comprises between about 3,20 mg and about 3.25 mg L-Histidine, per vial. In some embodiments, tire pharmaceutical composition comprises about 3.12 mg, about 3.13 mg, about 3.14 mg, about 3.15 mg, about 3.16 mg, about 3.17 mg, about 3.18 mg, about 3.19 mg, about 3.20 mg, about 3.21 mg, about 3.22 mg, about 3.23 mg, about 3.24 mg, about 3.25 mg, about 3.26 mg, about 3.27 mg, about 3.28 mg, about 3.29 mg, about 3.30 mg, about 3.31 mg, or about 3.32 mg L-Histidine, per vial. In some embodiments, the pharmaceutical composition comprises about 3.22 mg L-Histidine, per vial.

[0238] In some embodiments, the pharmaceutical composition comprises between about 46.84 mg and about 48.84 mg mannitol, per vial. In some embodiments, the pharmaceutical composition comprises between about 47.34 mg and about 48.34 mg mannitol, per vial. In some embodiments, the pharmaceutical composition comprises between about 47.64 mg and about 48.04 mg mannitol, per vial. In some embodiments, the pharmaceutical composition comprises between about 47.74 mg and about 47.94 mg mannitol, per vial. In some embodiments, the pharmaceutical composition comprises about 46.84 mg, about 46.94 mg, about 47.04 mg, about 47.14 mg, about 47.24 mg, about 47.34 mg, about 47.44 mg, about 47.54 mg, about 47.64 mg, about 47.74 mg, about 47.84 mg, about 47.94 mg, about 48.04 mg,VECT-007 / 001WO (43765-02067)about 48.14 mg, about 48.24 mg, about 48.34 mg, about 48.44 mg, about 48.54 mg, about 48.64 mg, about 48.74 mg, or about 48.84 mg mannitol, per vial. In some embodiments, the pharmaceutical composition comprises about 47.84 mg mannitol, per vial.

[0239] In some embodiments, prior to lyophilization, the pharmaceutical composition is pH adjusted with sodium hydroxide (NaOH) to about pH 8.0 to about pH 8.5. In some embodiments, the pH is adjusted to about 8.0, about 8.1, about 8.2, about 8.3, about 8.4, or about 8.5. In some embodiments, the pH is adjusted to about 8.3.

[0240] In some embodiments, the pharmaceutical composition is an aqueous pharmaceutical composition, and apraglutide is present as a free acid. In some embodiments, the aqueous pharmaceutical composition comprises about 18.5 mg / mL to about 23.5 mg / mL apraglutide. In some embodiments, the aqueous pharmaceutical composition comprises about 18.9 mg / mL to about 23.1 mg / mL apraglutide. In some embodiments, the aqueous pharmaceutical composition comprises about 18.5 mg / mL, 18.7 mg / mL, 18.9 mg / mL, 20.1 mg / mL, about 20.3 mg / mL, about 20.5 mg / mL, about 20.7 mg / mL, about 20.9 mg / mL, about 21.0 mg / mL, about 21.2 mg / mL, about 21.4 mg / mL, about 21.6 mg / mL, about 21.8 mg / mL, about 22.0 mg / mL, 22.2 mg / mL, about 22.4 mg / mL, about 22.6 mg / mL, about 22.8 mg / mL, about 23.0 mg / mL, or about 23.1 mg / mL of apraglutide. In some embodiments, the aqueous pharmaceutical composition comprises about 21.0 mg / mL apraglutide.

[0241] In some embodiments, the apraglutide concentration in the reconstituted formulation is about 8.8 mg / mL. In some embodiments, the apraglutide concentration in the reconstituted formulation is about 20.3 mg / mL. In some embodiments, the apraglutide concentration in the reconstituted formulation is about 20.6 mg / mL. In some embodiments, the apraglutide concentration in the reconstituted formulation is about 21.0 mg / mL. In some embodiments, the apraglutide concentration in the reconstituted formulation is about 8.8 mg / mL or more, about 10.0 mg / mL or more, about 12.0 mg / mL or more, about 15.0 mg / mL or more, or about 18.0 mg / mL or more. The reconstituted formulation may be reconstituted in sterile water. In some embodiments, the apraglutide concentration is 21.0 mg / mL or less, about 20.6 mg / mL or less, about 20.0 mg / mL or less, about 18.0 mg / mL or less, about 15.0 mg / mL or less, or about 12.0 mg / mL or less. In some embodiments, apraglutide concentration ranges from about 8.8 mg / mL to about 21.0 mg / mL. In some embodiments, apraglutide concentration ranges from about 8.8 mg / mL to about 20.6 mg / mL. In some embodiments, apraglutide concentration ranges from about 8.8 mg / mL to about 20.3 mg / mL. In some embodiments, apraglutide concentration ranges from about 21.0 mg / mL to about 20.3 mg / mL.

[0242] In some embodiments, the aqueous pharmaceutical composition comprisesVECT-007 / 001WO (43765-02067)about 2.2 mg / mL to about 4.2 mg / mL glycine. In some embodiments, the aqueous pharmaceutical composition comprises about 2.7 mg / mL to about 3.7 mg / mL glycine. In some embodiments, the aqueous pharmaceutical composition comprises about 2.9 mg / mL to about 3.5 mg / mL glycine. In some embodiments, the pharmaceutical composition comprises about 2.2 mg / mL, about 2.4 mg / mL, about 2.5 mg / mL, about 2.6 mg / mL, about 2.8 mg / mL, about 3.0 mg / mL, about 3,1 mg / mL, about 3.2 mg / mL, about 3.4 mg / mL, about 3.5 mg / mL, about 3.8 mg / mL, about 4.0 mg / mL, or about 4.2 mg / mL of glycine. In some embodiments, the aqueous pharmaceutical composition comprises about 3.2 mg / mL glycine.

[0243] In some embodiments, the aqueous pharmaceutical composition comprises about 0.3 mg / mL to about 2.3 mg / mL glycine. In some embodiments, the aqueous pharmaceutical composition comprises about 0.8 mg / mL to about 1.8 mg / mL glycine. In some embodiments, the aqueous pharmaceutical composition comprises about 1.0 mg / mL to about 1.6 mg / mL glycine. In some embodiments, the pharmaceutical composition comprises about 0.2 mg / mL, about 0.4 mg / mL, about 0.5 mg / mL, about 0.6 mg / mL, about 0.8 mg / mL, about 1.0 mg / mL, about 1.1 mg / mL, about 1.2 mg / mL, about 1.3 mg / mL, about 1.4 mg / mL, about 1.52 mg / mL, about 1.6 mg / mL, about 1.8 mg / mL, about 2.0 mg / mL, or about 2.2 mg / mL of glycine. In some embodiments, the aqueous pharmaceutical composition comprises about 1.3 mg / mL glycine.

[0244] In some embodiments, the aqueous pharmaceutical composition comprises about 2.1 mg / mL to about 4.1 mg / mL glycine. In some embodiments, the aqueous pharmaceutical composition comprises about 2.5 mg / mL to about 3.5 mg / mL glycine. In some embodiments, the aqueous pharmaceutical composition comprises about 2.9 mg / mL to about 3.3 mg / mL glycine. In some embodiments, the pharmaceutical composition comprises about 2.1 mg / mL, about 2.4 mg / mL, about 2.5 mg / mL, about 2.6 mg / mL, about 2.8 mg / mL, about 3.0 mg / mL, about 3.1 mg / mL, about 3.2 mg / mL, about 3.3 mg / mL, about 3.4 mg / mL, about 3.5 mg / mL, about 3.8 mg / mL, about 4.0 mg / mL, or about 4.1 mg / mL of glycine. In some embodiments, the aqueous pharmaceutical composition comprises about 3.1 mg / mL glycine. In some embodiments, the aqueous pharmaceutical composition comprises about 6.0 mg / mL to about 7.0 mg / mL L-histidine. In some embodiments, the aqueous pharmaceutical composition comprises about 6.2 mg / mL to about 6.8 mg / mL L-histidine. In some embodiments, the aqueous pharmaceutical composition comprises about 6,3 mg / mL to about 6.6 mg / mL L-histidine. In some embodiments, the pharmaceutical composition comprises about 6.0 mg / mL, about 6.1 mg / mL, about 6.2 mg / mL, about 6.3 mg / mL, about 6.4 mg / mL, about 6.5 mg / mL, about 6.6 mg / mL, about 6.7 mg / mL, about 6.8 mg / mL, about 6.9 mg / mL, or about 7.0 mg / mL of L-histidine. In some embodiments, the aqueous pharmaceuticalVECT-007 / 001WO (43765-02067)composition comprises about 6.5 mg / mL L-histidine. In some embodiments, the aqueous pharmaceutical composition comprises about 6.4 mg / mL L-histidine.

[0245] In some embodiments, the aqueous pharmaceutical composition comprises about 1.7 mg / mL to about 3.7 mg / mL L-histidine. In some embodiments, the aqueous pharmaceutical composition comprises about 2.2 mg / mL to about 3.2 mg / mL L-histidine. In some embodiments, the aqueous pharmaceutical composition comprises about 2.5 mg / mL to about 3.5 mg / mL L-histidine. In some embodiments, the pharmaceutical composition comprises about 1.7 mg / mL, about 1.8 mg / mL, about 2.0 mg / mL, about 2.1 mg / mL, about 2.2 mg / mL, about 2.3 mg / mL, about 2.4 mg / mL, about 2.5 mg / mL, about 2.7 mg / mL, about 2.9 mg / mL, about 3.3, or about 3.7 mg / mL of L-histidine. In some embodiments, the aqueous pharmaceutical composition comprises about 2.73 mg / mL L-histidine.

[0246] In some embodiments, the aqueous pharmaceutical composition comprises about 86.0 mg / mL to about 106.0 mg / mL mannitol. In some embodiments, the aqueous pharmaceutical composition comprises about 91.0 mg / mL to about 101.0 mg / mL mannitol. In some embodiments, the aqueous pharmaceutical composition comprises about 93.0 mg / mL to about 99.0 mg / mL mannitol. In some embodiments, the pharmaceutical composition comprises about 86.0 mg / mL, about 87.0 mg / mL, about 88.0 mg / mL, about 89.0 mg / mL, about 90.0 mg / mL, about 91.0 mg / mL, about 92.0 mg / mL, about 93.0 mg / mL, about 94.0 mg / mL, about 95.0 mg / mL, about 96.0 mg / mL, about 97.0 mg / mL, about 98.0 mg / mL, about 99.0 mg / mL, about 100.0 mg / mL, about 101.0 mg / mL, about 102.0 mg / mL, about 103.0 mg / mL, about 104.0 mg / mL, about 105.0 mg / mL, or about 106.0 mg / mL of mannitol. In some embodiments, the aqueous pharmaceutical composition comprises about 95.0 mg / mL mannitol. In some embodiments, the aqueous pharmaceutical composition comprises about 97.0 mg / mL mannitol.

[0247] In some embodiments, the aqueous pharmaceutical composition comprises about 35.6 mg / mL to about 46.6 mg / mL mannitol, in some embodiments, the aqueous pharmaceutical composition comprises about 38.6 mg / mL to about 43.6 mg / mL mannitol. In some embodiments, the aqueous pharmaceutical composition comprises about 39.6 mg / mL to about 42.6 mg / mL mannitol. In some embodiments, the pharmaceutical composition comprises about 35.6 mg / mL, about 36.6 mg / mL, about 37.6 mg / mL, about 38.6 mg / mL, about 39.6 mg / mL, about 40 mg / mL, about 40.6 mg / mL, about 41 mg / mL, about 41.6 mg / mL, about 42.5 mg / mL, about 43.6 mg / mL, about 44.6 mg / mL, about 45.6 mg / mL, or about 46.6 mg / mL of mannitol. In some embodiments, the aqueous pharmaceutical composition comprises about 41 mg / mL mannitol. In some embodiments, the aqueous pharmaceutical compositionVECT-007 / 001WO (43765-02067)comprises about 40.6 mg / mL mannitol.

[0248] In some embodiments, the aqueous pharmaceutical composition is pH adjusted with sodium hydroxide (NaOH) to about pH 8.0 to about pH 8.5. In some embodiments, the pH is adjusted to about 8.0, about 8.1, about 8.2, about 8.3, about 8.4, or about 8.5. In some embodiments, the pH is adjusted to about 8.3.

[0249] In some embodiments, the pharmaceutical composition comprises apraglutide or a pharmaceutically acceptable salt thereof at a quantity of about 5.2 mg per vial, glycine at about 0.78 mg per vial, L-histidine at about 1.61 mg per vial, and mannitol at about 23.92 mg per vial, for example in a lyophilized cake which may be prepared from a pre-lyophilization solution comprises apraglutide at about 10.0 mg / mL, glycine at about 1.5 mg / mL, L-histidine at about 3.1 mg / mL, and mannitol at about 46.0 mg / mL. Upon reconstitution, the pharmaceutical composition comprises apraglutide at about 21.0 mg / mL, glycine at about 3.1 mg / mL, L-histidine at about 6.4 mg / mL, and mannitol at about 95,0 mg / mL. The effective added reconstitution volume is about 0.23 mL.

[0250] In some embodiments, the pharmaceutical composition comprises apraglutide or a pharmaceutically acceptable salt thereof at a quantity of about 10.4 mg per vial, glycine at about 1.56 mg per vial, L-histidine at about 3.22 mg per vial, and mannitol at about 47.84 mg per vial, for example in a lyophilized cake which may be prepared from a pre-lyophilization solution comprises apraglutide at about 10.0 mg / mL, glycine at about 1.5 mg / mL, L-histidine at about 3,1 mg / mL, and mannitol at about 46,0 mg / mL, Upon reconstitution, the pharmaceutical composition comprises apraglutide at about 21.0 mg / mL, glycine at about 3.2 mg / mL, L-histidine at about 6.5 mg / mL, and mannitol at about 97.0 mg / mL. The effective added reconstitution volume is about 0.45 mL.

[0251] In some embodiments, the pharmaceutical composition comprises apraglutide or a pharmaceutically acceptable salt thereof at a quantity of about 5.4 mg per vial, glycine at about 0.81 mg per vial, L-histidine at about 1.67 mg per vial, and mannitol at about 24.84 mg per vial, for example in a lyophilized cake which may be prepared from a pre-lyophilization solution comprises apraglutide at about 10.0 mg / mL, glycine at about 1.5 mg / mL, L-histidine at about 3.1 mg / mL, and mannitol at about 46.0 mg / mL. Upon reconstitution, the pharmaceutical composition comprises apraglutide at about 17.3 mg / mL, glycine at about 2.6 mg / mL, L-histidine at about 5.3 mg / mL, and mannitol at about 79.5 mg / mL. Tire effective added reconstitution volume is about 0.29 mL.

[0252] In some embodiments, the pharmaceutical composition comprises apraglutide or a pharmaceutically acceptable salt thereof at a quantity of about 5.4 mg per vial, glycine atVECT-007 / 001WO (43765-02067)about 0.81 mg per vial, L-histidine at about 1.67 mg per vial, and mannitol at about 24.84 mg per vial, for example in a lyophilized cake which may be prepared from a pre -lyophilization solution comprises apraglutide at about 5.4 mg / mL, glycine at about 0.8 mg / mL, L-histidine at about 1.7 mg / mL, and mannitol at about 24.5 mg / mL. Upon reconstitution, the pharmaceutical composition comprises apraglutide at about 8.8 mg / mL, glycine at about 1.3 mg / mL, L-histidine at about 2.7 mg / mL, and mannitol at about 40.6 mg / mL. The effective added reconstitution volume is about 0.59 mL.

[0253] In some embodiments, the pharmaceutical composition comprises apraglutide or a pharmaceutically acceptable salt thereof at a quantity of about 5.4 mg per vial, glycine at about 0.81 mg per vial, L-histidine at about 1.67 mg per vial, and mannitol at about 24.84 mg per vial, for example in a lyophilized cake which may be prepared from a pre-lyophilization solution comprises apraglutide at about 10.0 mg / mL, glycine at about 1.5 mg / mL, L-histidine at about 3,1 mg / mL, and mannitol at about 46,0 mg / mL, Upon reconstitution, the pharmaceutical composition comprises apraglutide at about 14.1 mg / mL, glycine at about 2.1 mg / mL, L-histidine at about 4.4 mg / mL, and mannitol at about 64.9 mg / mL. The effective added reconstitution volume is about 0.36 mL.

[0254] In some embodiments, the pharmaceutical composition comprises apraglutide or a pharmaceutically acceptable salt thereof at a quantity of about 10.4 mg per vial, glycine at about 1.56 mg per vial, L-histidine at about 3.22 mg per vial, and mannitol at about 47.84 mg per vial, for example in a lyophilized cake which may be prepared from a pre-lyophilization solution comprises apraglutide at about 10.0 mg / mL, glycine at about 1.5 mg / mL, L-histidine at about 3.1 mg / mL, and mannitol at about 46.0 mg / mL. Upon reconstitution, the pharmaceutical composition comprises apraglutide at about 17.5 mg / mL, glycine at about 2.6 mg / mL, L-histidine at about 5.4 mg / mL, and mannitol at about 80.6 mg / mL. Tire effective added reconstitution volume is about 0.55 mL.

[0255] In some embodiments, the pharmaceutical composition comprises:(a) apraglutide in an amount of about 8 % to about 25 % by weight of total solids; (b) a buffering agent in an amount of about 0.75 % to about 4.25 % by weight;(c) a stabilizing agent in an amount of about 2.55 % to about 7.65 % by weight; and (d) a bulking agent in an amount of about 63.15 % to about 88.65 % by weight.

[0256] In some embodiments, the pharmaceutical composition comprises:(a) apraglutide in an amount of about 10% to about 23% by weight of total solids; (b) a buffering agent in an amount of about 0.75% to about 4.25% by weight;(c) a stabilizing agent in an amount of about 2.55% to about 7.65% by weight; andVECT-007 / 001WO (43765-02067)(d) a bulking agent in an amount of about 63.15% to about 88.65% by weight.

[0257] In some embodiments, the pharmaceutical composition comprises:(a) apraglutide in an amount of about 14% to about 19% by weight of total solids; (b) a buffering agent in an amount of about 0.75% to about 4.25% by weight;(c) a stabilizing agent in an amount of about 2.55% to about 7.65% by weight; and (d) a bulking agent in an amount of about 63,15% to about 88.65% by weight.

[0258] In some embodiments, the pharmaceutical composition comprises:(a) apraglutide in an amount of about 15.5% to about 17.5% by weight of total solids; (b) a buffering agent in an amount of about 0.75% to about 4.25% by weight;(c) a stabilizing agent in an amount of about 2.55% to about 7.65% by weight; and (d) a bulking agent in an amount of about 63.15% to about 88.65% by weight.

[0259] In some embodiments, the pharmaceutical composition comprises:(a) apraglutide in an amount of about 16,5% by weight of total solids;(b) a buffering agent in an amount of about 0.75% to about 4.25% by weight;(c) a stabilizing agent in an amount of about 2.55% to about 7.65% by weight; and (d) a bulking agent in an amount of about 63.15% to about 88.65% by weight.

[0260] In some embodiments, the pharmaceutical composition comprises:(a) apraglutide in an amount of about 8% to about 25% by weight of total solids; (b) a buffering agent in an amount of about 1.25% to about 3.75% by weight;(c) a stabilizing agent in an amount of about 2.55% to about 7.65% by weight; and (d) a bulking agent in an amount of about 63.15% to about 88.65% by weight.

[0261] In some embodiments, the pharmaceutical composition comprises:(a) apraglutide in an amount of about 8% to about 25% by weight of total solids; (b) a buffering agent in an amount of about 2.0% to about 3.0% by weight;(c) a stabilizing agent in an amount of about 2.55% to about 7.65% by weight; and (d) a bulking agent in an amount of about 63.15% to about 88.65% by weight.

[0262] In some embodiments, the pharmaceutical composition comprises:(a) apraglutide in an amount of about 8% to about 25% by weight of total solids; (b) a buffering agent in an amount of about 2.3% to about 2.7% by weight;(c) a stabilizing agent in an amount of about 2.55% to about 7.65% by weight; and (d) a bulking agent in an amount of about 63.15% to about 88.65% by weight.

[0263] In some embodiments, the pharmaceutical composition comprises:(a) apraglutide in an amount of about 8% to about 25% by weight of total solids; (b) a buffering agent in an amount of about 2.5% by weight;VECT-007 / 001WO (43765-02067)(c) a stabilizing agent in an amount of about 2.55% to about 7.65% by weight; and (d) a bulking agent in an amount of about 63.15% to about 88.65% by weight.

[0264] In some embodiments, the pharmaceutical composition comprises:(a) apraglutide in an amount of about 10% to about 23% by weight of total solids; (b) a buffering agent in an amount of about 1.25% to about 3.75% by weight;(c) a stabilizing agent in an amount of about 2.55% to about 7.65% by weight; and (d) a bulking agent in an amount of about 63.15% to about 88.65% by weight.

[0265] In some embodiments, the pharmaceutical composition comprises:(a) apraglutide in an amount of about 10% to about 23% by weight of total solids; (b) a buffering agent in an amount of about 2.0% to about 3.0% by weight;(c) a stabilizing agent in an amount of about 2.55% to about 7.65% by weight; and (d) a bulking agent in an amount of about 63.15% to about 88.65% by weight.

[0266] In some embodiments, the pharmaceutical composition comprises:(a) apraglutide in an amount of about 10% to about 23% by weight of total solids; (b) a buffering agent in an amount of about 2.3% to about 2.7% by weight;(c) a stabilizing agent in an amount of about 2.55% to about 7.65% by weight; and (d) a bulking agent in an amount of about 63.15% to about 88.65% by weight.

[0267] In some embodiments, the pharmaceutical composition comprises:(a) apraglutide in an amount of about 10% to about 23% by weight of total solids; (b) a buffering agent in an amount of about 2,5% by weight;(c) a stabilizing agent in an amount of about 2.55% to about 7.65% by weight; and (d) a bulking agent in an amount of about 63.15% to about 88.65% by weight.

[0268] In some embodiments, the pharmaceutical composition comprises:(a) apraglutide in an amount of about 14% to about 19% by weight of total solids; (b) a buffering agent in an amount of about 1.25% to about 3.75% by weight;(c) a stabilizing agent in an amount of about 2.55% to about 7.65% by weight; and (d) a bulking agent in an amount of about 63,15% to about 88.65% by weight.

[0269] In some embodiments, the pharmaceutical composition comprises:(a) apraglutide in an amount of about 14% to about 19% by weight of total solids; (b) a buffering agent in an amount of about 2.0% to about 3.0% by weight;(c) a stabilizing agent in an amount of about 2.55% to about 7,65% by weight; and (d) a bulking agent in an amount of about 63.15% to about 88.65% by weight.

[0270] In some embodiments, the pharmaceutical composition comprises:(a) apraglutide in an amount of about 14% to about 19% by weight of total solids;VECT-007 / 001WO (43765-02067)(b) a buffering agent in an amount of about 2.3% to about 2.7% by weight;(c) a stabilizing agent in an amount of about 2.55% to about 7.65% by weight; and (d) a bulking agent in an amount of about 63.15% to about 88.65% by weight.

[0271] In some embodiments, the pharmaceutical composition comprises:(a) apraglutide in an amount of about 14% to about 19% by weight of total solids; (b) a buffering agent in an amount of about 2,5% by weight;(c) a stabilizing agent in an amount of about 2.55% to about 7.65% by weight; and (d) a bulking agent in an amount of about 63.15% to about 88.65% by weight.

[0272] In some embodiments, the pharmaceutical composition comprises:(a) apraglutide in an amount of about 15.5% to about 17.5% by weight of total solids; (b) a buffering agent in an amount of about 1.25% to about 3.75% by weight;(c) a stabilizing agent in an amount of about 2.55% to about 7.65% by weight; and (d) a bulking agent in an amount of about 63,15% to about 88.65% by weight.

[0273] In some embodiments, the pharmaceutical composition comprises:(a) apraglutide in an amount of about 15.5% to about 17.5% by weight of total solids; (b) a buffering agent in an amount of about 2.0% to about 3.0% by weight;(c) a stabilizing agent in an amount of about 2.55% to about 7,65% by weight; and (d) a bulking agent in an amount of about 63.15% to about 88.65% by weight.

[0274] In some embodiments, the pharmaceutical composition comprises:(a) apraglutide in an amount of about 15.5% to about 17.5% by weight of total solids; (b) a buffering agent in an amount of about 2.3% to about 2.7% by weight;(c) a stabilizing agent in an amount of about 2.55% to about 7.65% by weight; and (d) a bulking agent in an amount of about 63.15% to about 88.65% by weight.

[0275] In some embodiments, the pharmaceutical composition comprises:(a) apraglutide in an amount of about 15.5% to about 17.5% by weight of total solids; (b) a buffering agent in an amount of about 2.5% by weight;(c) a stabilizing agent in an amount of about 2.55% to about 7.65% by weight; and (d) a bulking agent in an amount of about 63.15% to about 88.65% by weight.

[0276] In some embodiments, the pharmaceutical composition comprises:(a) apraglutide in an amount of about 16.5% by weight of total solids;(b) a buffering agent in an amount of about 1.25% to about 3.75% by weight;(c) a stabilizing agent in an amount of about 2,55% to about 7.65% by weight; and (d) a bulking agent in an amount of about 63.15% to about 88.65% by weight.

[0277] In some embodiments, the pharmaceutical composition comprises:VECT-007 / 001WO (43765-02067)(a) apraglutide in an amount of about 16.5% by weight of total solids;(b) a buffering agent in an amount of about 2.0% to about 3.0% by weight;(c) a stabilizing agent in an amount of about 2.55% to about 7.65% by weight; and (d) a bulking agent in an amount of about 63.15% to about 88.65% by weight.

[0278] In some embodiments, the pharmaceutical composition comprises:(a) apraglutide in an amount of about 16,5% by weight of total solids;(b) a buffering agent in an amount of about 2.3% to about 2.7% by weight;(c) a stabilizing agent in an amount of about 2.55% to about 7.65% by weight; and (d) a bulking agent in an amount of about 63.15% to about 88.65% by weight.

[0279] In some embodiments, the pharmaceutical composition comprises:(a) apraglutide in an amount of about 16.5% by weight of total solids;(b) a buffering agent in an amount of about 2.5% by weight;(c) a stabilizing agent in an amount of about 2.55% to about 7.65% by weight; and (d) a bulking agent in an amount of about 63.15% to about 88.65% by weight.

[0280] In some embodiments, the pharmaceutical composition comprises:(a) apraglutide in an amount of about 8% to about 25% by weight of total solids; (b) a buffering agent in an amount of about 0.75% to about 4.25% by weight;(c) a stabilizing agent in an amount of about 3.5% to about 6.7% by weight; and (d) a bulking agent in an amount of about 63.15% to about 88.65% by weight.

[0281] In some embodiments, the pharmaceutical composition comprises:(a) apraglutide in an amount of about 8% to about 25% by weight of total solids; (b) a buffering agent in an amount of about 0.75% to about 4.25% by weight;(c) a stabilizing agent in an amount of about 4.35% to about 5.85% by weight; and (d) a bulking agent in an amount of about 63.15% to about 88.65% by weight.

[0282] In some embodiments, the pharmaceutical composition comprises:(a) apraglutide in an amount of about 8% to about 25% by weight of total solids; (b) a buffering agent in an amount of about 0,75% to about 4,25% by weight;(c) a stabilizing agent in an amount of about 4.9% to about 5.3% by weight; and (d) a bulking agent in an amount of about 63.15% to about 88.65% by weight.

[0283] In some embodiments, the pharmaceutical composition comprises:(a) apraglutide in an amount of about 8% to about 25% by weight of total solids; (b) a buffering agent in an amount of about 0.75% to about 4.25% by weight;(c) a stabilizing agent in an amount of about 5.1% by weight; and(d) a bulking agent in an amount of about 63.15% to about 88.65% by weight.VECT-007 / 001WO (43765-02067)

[0284] In some embodiments, the pharmaceutical composition comprises:(a) apraglutide in an amount of about 10% to about 23% by weight of total solids; (b) a buffering agent in an amount of about 0.75% to about 4.25% by weight;(c) a stabilizing agent in an amount of about 3.5% to about 6.7% by weight; and (d) a bulking agent in an amount of about 63.15% to about 88.65% by weight.

[0285] In some embodiments, the pharmaceutical composition comprises:(a) apraglutide in an amount of about 10% to about 23% by weight of total solids; (b) a buffering agent in an amount of about 0.75% to about 4.25% by weight;(c) a stabilizing agent in an amount of about 4.35% to about 5.85% by weight; and (d) a bulking agent in an amount of about 63.15% to about 88.65% by weight.

[0286] In some embodiments, the pharmaceutical composition comprises:(a) apraglutide in an amount of about 10% to about 23% by weight of total solids; (b) a buffering agent in an amount of about 0,75% to about 4,25% by weight;(c) a stabilizing agent in an amount of about 4.9% to about 5.3% by weight; and (d) a bulking agent in an amount of about 63.15% to about 88.65% by weight.

[0287] In some embodiments, the pharmaceutical composition comprises:(a) apraglutide in an amount of about 10% to about 23% by weight of total solids; (b) a buffering agent in an amount of about 0.75% to about 4.25% by weight;(c) a stabilizing agent in an amount of about 5.1% by weight; and(d) a bulking agent in an amount of about 63,15% to about 88.65% by weight.

[0288] In some embodiments, the pharmaceutical composition comprises:(a) apraglutide in an amount of about 14% to about 19% by weight of total solids; (b) a buffering agent in an amount of about 0.75% to about 4.25% by weight;(c) a stabilizing agent in an amount of about 3.5% to about 6.7% by weight; and (d) a bulking agent in an amount of about 63.15% to about 88.65% by weight.

[0289] In some embodiments, the pharmaceutical composition comprises:(a) apraglutide in an amount of about 14% to about 19% by weight of total solids; (b) a buffering agent in an amount of about 0.75% to about 4.25% by weight;(c) a stabilizing agent in an amount of about 4.35% to about 5.85% by weight; and (d) a bulking agent in an amount of about 63.15% to about 88.65% by weight.

[0290] In some embodiments, the pharmaceutical composition comprises:(a) apraglutide in an amount of about 14% to about 19% by weight of total solids; (b) a buffering agent in an amount of about 0.75% to about 4.25% by weight;(c) a stabilizing agent in an amount of about 4.9% to about 5.3% by weight; andVECT-007 / 001WO (43765-02067)(d) a bulking agent in an amount of about 63.15% to about 88.65% by weight.

[0291] In some embodiments, the pharmaceutical composition comprises:(a) apraglutide in an amount of about 14% to about 19% by weight of total solids; (b) a buffering agent in an amount of about 0.75% to about 4.25% by weight;(c) a stabilizing agent in an amount of about 5.1% by weight; and(d) a bulking agent in an amount of about 63,15% to about 88.65% by weight.

[0292] In some embodiments, the pharmaceutical composition comprises:(a) apraglutide in an amount of about 15.5% to about 17.5% by weight of total solids; (b) a buffering agent in an amount of about 0.75% to about 4.25% by weight;(c) a stabilizing agent in an amount of about 3.5% to about 6.7% by weight; and (d) a bulking agent in an amount of about 63.15% to about 88.65% by weight.

[0293] In some embodiments, the pharmaceutical composition comprises:(a) apraglutide in an amount of about 15.5% to about 17.5% by weight of total solids; (b) a buffering agent in an amount of about 0.75% to about 4.25% by weight;(c) a stabilizing agent in an amount of about 4.35% to about 5.85% by weight; and (d) a bulking agent in an amount of about 63.15% to about 88.65% by weight.

[0294] In some embodiments, the pharmaceutical composition comprises:(a) apraglutide in an amount of about 15.5% to about 17.5% by weight of total solids; (b) a buffering agent in an amount of about 0.75% to about 4.25% by weight;(c) a stabilizing agent in an amount of about 4.9% to about 5.3% by weight; and (d) a bulking agent in an amount of about 63.15% to about 88.65% by weight.

[0295] In some embodiments, the pharmaceutical composition comprises:(a) apraglutide in an amount of about 15.5% to about 17.5% by weight of total solids; (b) a buffering agent in an amount of about 0.75% to about 4.25% by weight;(c) a stabilizing agent in an amount of about 5.1% by weight; and(d) a bulking agent in an amount of about 63.15% to about 88.65% by weight.

[0296] In some embodiments, the pharmaceutical composition comprises:(a) apraglutide in an amount of about 16.5% by w eight of total solids;(b) a buffering agent in an amount of about 0.75% to about 4.25% by weight;(c) a stabilizing agent in an amount of about 3.5% to about 6.7% by weight; and (d) a bulking agent in an amount of about 63.15% to about 88.65% by weight.

[0297] In some embodiments, the pharmaceutical composition comprises:(a) apraglutide in an amount of about 16.5% by weight of total solids;(b) a buffering agent in an amount of about 0.75% to about 4.25% by weight;VECT-007 / 001WO (43765-02067)(c) a stabilizing agent in an amount of about 4.35% to about 5.85% by weight; and (d) a bulking agent in an amount of about 63.15% to about 88.65% by weight.

[0298] In some embodiments, the pharmaceutical composition comprises:(a) apraglutide in an amount of about 16.5% by weight of total solids;(b) a buffering agent in an amount of about 0.75% to about 4.25% by weight;(c) a stabilizing agent in an amount of about 4.9% to about 5.3% by weight; and (d) a bulking agent in an amount of about 63.15% to about 88.65% by weight.

[0299] In some embodiments, the pharmaceutical composition comprises:(a) apraglutide in an amount of about 16.5% by weight of total solids;(b) a buffering agent in an amount of about 0.75% to about 4.25% by weight;(c) a stabilizing agent in an amount of about 5.1% by weight; and(d) a bulking agent in an amount of about 63.15% to about 88.65% by weight.

[0300] In some embodiments, the pharmaceutical composition comprises:(a) apraglutide in an amount of about 8% to about 25% by weight of total solids; (b) a buffering agent in an amount of about 0.75% to about 4.25% by weight;(c) a stabilizing agent in an amount of about 2.55% to about 7.65% by weight; and (d) a bulking agent in an amount of about 69.15% to about 82.65% by weight.

[0301] In some embodiments, the pharmaceutical composition comprises:(a) apraglutide in an amount of about 8% to about 25% by weight of total solids; (b) a buffering agent in an amount of about 0,75% to about 4,25% by weight;(c) a stabilizing agent in an amount of about 2.55% to about 7.65% by weight; and (d) a bulking agent in an amount of about 72.9% to about 78.9% by weight.

[0302] In some embodiments, the pharmaceutical composition comprises:(a) apraglutide in an amount of about 8% to about 25% by weight of total solids; (b) a buffering agent in an amount of about 0.75% to about 4.25% by weight;(c) a stabilizing agent in an amount of about 2.55% to about 7.65% by weight; and (d) a bulking agent in an amount of about 74,9% to about 76,9% by weight.

[0303] In some embodiments, the pharmaceutical composition comprises:(a) apraglutide in an amount of about 8% to about 25% by weight of total solids; (b) a buffering agent in an amount of about 0.75% to about 4.25% by weight;(c) a stabilizing agent in an amount of about 2.55% to about 7,65% by weight; and (d) a bulking agent in an amount of about 75.9% by weight.

[0304] In some embodiments, the pharmaceutical composition comprises:(a) apraglutide in an amount of about 10% to about 23% by weight of total solids;VECT-007 / 001WO (43765-02067)(b) a buffering agent in an amount of about 0.75% to about 4.25% by weight;(c) a stabilizing agent in an amount of about 2.55% to about 7.65% by weight; and (d) a bulking agent in an amount of about 69.15% to about 82.65% by weight.

[0305] In some embodiments, the pharmaceutical composition comprises:(a) apraglutide in an amount of about 10% to about 23% by weight of total solids; (b) a buffering agent in an amount of about 0,75% to about 4,25% by weight;(c) a stabilizing agent in an amount of about 2.55% to about 7.65% by weight; and (d) a bulking agent in an amount of about 72.9% to about 78.9% by weight.

[0306] In some embodiments, the pharmaceutical composition comprises:(a) apraglutide in an amount of about 10% to about 23% by weight of total solids; (b) a buffering agent in an amount of about 0.75% to about 4.25% by weight;(c) a stabilizing agent in an amount of about 2.55% to about 7.65% by weight; and (d) a bulking agent in an amount of about 74,9% to about 76,9% by weight.

[0307] In some embodiments, the pharmaceutical composition comprises:(a) apraglutide in an amount of about 10% to about 23% by weight of total solids; (b) a buffering agent in an amount of about 0.75% to about 4.25% by weight;(c) a stabilizing agent in an amount of about 2.55% to about 7,65% by weight; and (d) a bulking agent in an amount of about 75.9% by weight.

[0308] In some embodiments, the pharmaceutical composition comprises:(a) apraglutide in an amount of about 14% to about 19% by weight of total solids; (b) a buffering agent in an amount of about 0.75% to about 4.25% by weight;(c) a stabilizing agent in an amount of about 2.55% to about 7.65% by weight; and (d) a bulking agent in an amount of about 69.15% to about 82.65% by weight.

[0309] In some embodiments, the pharmaceutical composition comprises:(a) apraglutide in an amount of about 14% to about 19% by weight of total solids; (b) a buffering agent in an amount of about 0.75% to about 4.25% by weight;(c) a stabilizing agent in an amount of about 2.55% to about 7.65% by weight; and (d) a bulking agent in an amount of about 72.9% to about 78.9% by weight.

[0310] In some embodiments, the pharmaceutical composition comprises:(a) apraglutide in an amount of about 14% to about 19% by weight of total solids; (b) a buffering agent in an amount of about 0.75% to about 4.25% by weight;(c) a stabilizing agent in an amount of about 2.55% to about 7.65% by weight; and (d) a bulking agent in an amount of about 74.9% to about 76.9% by weight.

[0311] In some embodiments, the pharmaceutical composition comprises:VECT-007 / 001WO (43765-02067)(a) apraglutide in an amount of about 14% to about 19% by weight of total solids; (b) a buffering agent in an amount of about 0.75% to about 4.25% by weight;(c) a stabilizing agent in an amount of about 2.55% to about 7.65% by weight; and (d) a bulking agent in an amount of about 75.9% by weight.

[0312] In some embodiments, the pharmaceutical composition comprises:(a) apraglutide in an amount of about 15.5% to about 17.5% by weight of total solids; (b) a buffering agent in an amount of about 0.75% to about 4.25% by weight;(c) a stabilizing agent in an amount of about 2.55% to about 7.65% by weight; and (d) a bulking agent in an amount of about 69.15% to about 82.65% by weight.

[0313] In some embodiments, the pharmaceutical composition comprises:(a) apraglutide in an amount of about 15.5% to about 17.5% by weight of total solids; (b) a buffering agent in an amount of about 0.75% to about 4.25% by weight;(c) a stabilizing agent in an amount of about 2.55% to about 7.65% by weight; and (d) a bulking agent in an amount of about 72.9% to about 78.9% by weight.

[0314] In some embodiments, the pharmaceutical composition comprises:(a) apraglutide in an amount of about 15.5% to about 17.5% by weight of total solids; (b) a buffering agent in an amount of about 0.75% to about 4.25% by weight;(c) a stabilizing agent in an amount of about 2.55% to about 7.65% by weight; and (d) a bulking agent in an amount of about 74.9% to about 76.9% by weight.

[0315] In some embodiments, the pharmaceutical composition comprises:(a) apraglutide in an amount of about 15.5% to about 17.5% by weight of total solids; (b) a buffering agent in an amount of about 0.75% to about 4.25% by weight;(c) a stabilizing agent in an amount of about 2.55% to about 7.65% by weight; and (d) a bulking agent in an amount of about 75.9% by weight.

[0316] In some embodiments, the pharmaceutical composition comprises:(a) apraglutide in an amount of about 16.5% by weight of total solids;(b) a buffering agent in an amount of about 0,75% to about 4,25% by weight;(c) a stabilizing agent in an amount of about 2.55% to about 7.65% by weight; and (d) a bulking agent in an amount of about 69.15% to about 82.65% by weight.

[0317] In some embodiments, the pharmaceutical composition comprises:(a) apraglutide in an amount of about 16.5% by weight of total solids;(b) a buffering agent in an amount of about 0.75% to about 4.25% by weight;(c) a stabilizing agent in an amount of about 2.55% to about 7,65% by weight; and (d) a bulking agent in an amount of about 72.9% to about 78.9% by weight.VECT-007 / 001WO (43765-02067)

[0318] In some embodiments, the pharmaceutical composition comprises:(a) apraglutide in an amount of about 16.5% by weight of total solids;(b) a buffering agent in an amount of about 0.75% to about 4.25% by weight;(c) a stabilizing agent in an amount of about 2.55% to about 7.65% by weight; and (d) a bulking agent in an amount of about 74.9% to about 76.9% by weight.

[0319] In some embodiments, the pharmaceutical composition comprises:(a) apraglutide in an amount of about 16.5% by weight of total solids;(b) a buffering agent in an amount of about 0.75% to about 4.25% by weight;(c) a stabilizing agent in an amount of about 2.55% to about 7.65% by weight; and (d) a bulking agent in an amount of about 75.9% by weight.

[0320] In some embodiments, the pharmaceutical composition comprises:(a) apraglutide in an amount of about 8 % to about 25 % by weight of total solids; (b) glycine in an amount of about 0.75 % to about 4.25 % by weight;(c) L-histidine in an amount of about 2.55 % to about 7.65 % by weight; and(d) mannitol in an amount of about 63.15 % to about 88.65 % by weight.

[0321] In some embodiments, the pharmaceutical composition comprises:(a) apraglutide in an amount of about 10% to about 23% by weight of total solids; (b) glycine in an amount of about 0.75% to about 4.25% by weight;(c) L-histidine in an amount of about 2.55% to about 7.65% by weight; and(d) mannitol in an amount of about 63.15% to about 88,65% by weight,

[0322] In some embodiments, the pharmaceutical composition comprises:(a) apraglutide in an amount of about 14% to about 19% by weight of total solids; (b) glycine in an amount of about 0.75% to about 4.25% by weight;(c) L-histidine in an amount of about 2,55% to about 7.65% by weight; and(d) mannitol in an amount of about 63.15% to about 88.65% by weight.

[0323] In some embodiments, the pharmaceutical composition comprises:(a) apraglutide in an amount of about 15.5% to about 17.5% by weight of total solids; (b) glycine in an amount of about 0.75% to about 4.25% by weight;(c) L-histidine in an amount of about 2.55% to about 7.65 % by weight; and(d) mannitol in an amount of about 63.15% to about 88.65% by weight.

[0324] In some embodiments, the pharmaceutical composition comprises:(a) apraglutide in an amount of about 16.5% by weight of total solids;(b) glycine in an amount of about 0.75% to about 4.25% by weight;(c) L-histidine in an amount of about 2.55% to about 7.65% by weight; andVECT-007 / 001WO (43765-02067)(d) mannitol in an amount of about 63.15% to about 88.65% by weight.

[0325] In some embodiments, the pharmaceutical composition comprises:(a) apraglutide in an amount of about 8% to about 25% by weight of total solids; (b) glycine in an amount of about 1.25% to about 3.75% by weight;(c) L-histidine in an amount of about 2.55% to about 7.65% by weight; and(d) mannitol in an amount of about 63.15% to about 88,65% by weight,

[0326] In some embodiments, the pharmaceutical composition comprises:(a) apraglutide in an amount of about 8% to about 25% by weight of total solids; (b) glycine in an amount of about 2.0% to about 3.0% by weight;(c) L-histidine in an amount of about 2.55% to about 7.65% by weight; and(d) mannitol in an amount of about 63.15% to about 88.65% by weight.

[0327] In some embodiments, the pharmaceutical composition comprises:(a) apraglutide in an amount of about 8% to about 25% by weight of total solids; (b) glycine in an amount of about 2.3% to about 2.7% by weight;(c) L-histidine in an amount of about 2.55% to about 7,65% by weight; and(d) mannitol in an amount of about 63.15% to about 88.65% by weight.

[0328] In some embodiments, the pharmaceutical composition comprises:(a) apraglutide in an amount of about 8% to about 25% by weight of total solids; (b) glycine in an amount of about 2.5% by weight;(c) L-histidine in an amount of about 2.55% to about 7,65% by weight; and(d) mannitol in an amount of about 63.15% to about 88.65% by weight.

[0329] In some embodiments, the pharmaceutical composition comprises:(a) apraglutide in an amount of about 10% to about 23% by weight of total solids; (b) glycine in an amount of about 1.25% to about 3.75% by weight;(c) L-histidine in an amount of about 2.55% to about 7.65% by weight; and(d) mannitol in an amount of about 63.15% to about 88.65% by weight.

[0330] In some embodiments, the pharmaceutical composition comprises:(a) apraglutide in an amount of about 10% to about 23% by weight of total solids; (b) glycine in an amount of about 2.0% to about 3.0% by weight;(c) L-histidine in an amount of about 2.55% to about 7.65% by weight; and(d) mannitol in an amount of about 63.15% to about 88.65% by weight.

[0331] In some embodiments, the pharmaceutical composition comprises:(a) apraglutide in an amount of about 10% to about 23% by weight of total solids; (b) glycine in an amount of about 2.3% to about 2.7% by weight;VECT-007 / 001WO (43765-02067)(c) L-histidine in an amount of about 2.55% to about 7.65% by weight; and(d) mannitol in an amount of about 63.15% to about 88.65% by weight.

[0332] In some embodiments, the pharmaceutical composition comprises:(a) apraglutide in an amount of about 10% to about 23% by weight of total solids; (b) glycine in an amount of about 2.5% by weight;(c) L-histidine in an amount of about 2.55% to about 7,65% by weight; and(d) mannitol in an amount of about 63.15% to about 88.65% by weight.

[0333] In some embodiments, the pharmaceutical composition comprises:(a) apraglutide in an amount of about 14% to about 19% by weight of total solids; (b) glycine in an amount of about 1.25% to about 3.75% by weight;(c) L-histidine in an amount of about 2.55% to about 7.65% by weight; and(d) mannitol in an amount of about 63.15% to about 88.65% by weight.

[0334] In some embodiments, the pharmaceutical composition comprises:(a) apraglutide in an amount of about 14% to about 19% by weight of total solids; (b) glycine in an amount of about 2.0% to about 3.0% by weight;(c) L-histidine in an amount of about 2.55% to about 7.65% by weight; and(d) mannitol in an amount of about 63.15% to about 88.65% by weight.

[0335] In some embodiments, the pharmaceutical composition comprises:(a) apraglutide in an amount of about 14% to about 19% by weight of total solids; (b) glycine in an amount of about 2.3% to about 2.7% by weight;(c) L-histidine in an amount of about 2.55% to about 7.65% by weight; and(d) mannitol in an amount of about 63.15% to about 88.65% by weight.

[0336] In some embodiments, the pharmaceutical composition comprises:(a) apraglutide in an amount of about 14% to about 19% by weight of total solids; (b) glycine in an amount of about 2.5% by weight;(c) L-histidine in an amount of about 2.55% to about 7.65% by weight; and(d) mannitol in an amount of about 63.15% to about 88,65% by weight,

[0337] In some embodiments, the pharmaceutical composition comprises:(a) apraglutide in an amount of about 15.5% to about 17.5% by weight of total solids; (b) glycine in an amount of about 1.25% to about 3.75% by weight;(c) L-histidine in an amount of about 2,55% to about 7.65% by weight; and(d) mannitol in an amount of about 63.15% to about 88.65% by weight.

[0338] In some embodiments, the pharmaceutical composition comprises:(a) apraglutide in an amount of about 15.5% to about 17.5% by weight of total solids;VECT-007 / 001WO (43765-02067)(b) glycine in an amount of about 2.0% to about 3.0% by weight;(c) L-histidine in an amount of about 2.55% to about 7.65% by weight; and(d) mannitol in an amount of about 63.15% to about 88.65% by weight.

[0339] In some embodiments, the pharmaceutical composition comprises:(a) apraglutide in an amount of about 15.5% to about 17.5% by weight of total solids; (b) glycine in an amount of about 2.3% to about 2.7% by weight;(c) L-histidine in an amount of about 2.55% to about 7.65% by weight; and(d) mannitol in an amount of about 63.15% to about 88.65% by weight.

[0340] In some embodiments, the pharmaceutical composition comprises:(a) apraglutide in an amount of about 15.5% to about 17.5% by weight of total solids; (b) glycine in an amount of about 2.5% by weight;(c) L-histidine in an amount of about 2.55% to about 7.65% by weight; and(d) mannitol in an amount of about 63.15% to about 88,65% by weight,

[0341] In some embodiments, the pharmaceutical composition comprises:(a) apraglutide in an amount of about 16.5% by weight of total solids;(b) glycine in an amount of about 1.25% to about 3.75% by weight;(c) L-histidine in an amount of about 2,55% to about 7.65% by weight; and(d) mannitol in an amount of about 63.15% to about 88.65% by weight.

[0342] In some embodiments, the pharmaceutical composition comprises:(a) apraglutide in an amount of about 16,5% by weight of total solids;(b) glycine in an amount of about 2.0% to about 3.0% by weight;(c) L-histidine in an amount of about 2.55% to about 7.65% by weight; and(d) mannitol in an amount of about 63.15% to about 88.65% by weight.

[0343] In some embodiments, the pharmaceutical composition comprises:(a) apraglutide in an amount of about 16.5% by weight of total solids;(b) glycine in an amount of about 2.3% to about 2.7% by weight;(c) L-histidine in an amount of about 2.55% to about 7,65% by weight; and(d) mannitol in an amount of about 63.15% to about 88.65% by weight.

[0344] In some embodiments, the pharmaceutical composition comprises:(a) apraglutide in an amount of about 16.5% by weight of total solids;(b) glycine in an amount of about 2,5% by weight;(c) L-histidine in an amount of about 2.55% to about 7.65% by weight; and(d) mannitol in an amount of about 63.15% to about 88.65% by weight.

[0345] In some embodiments, the pharmaceutical composition comprises:VECT-007 / 001WO (43765-02067)(a) apraglutide in an amount of about 8% to about 25% by weight of total solids; (b) glycine in an amount of about 0.75% to about 4.25% by weight;(c) L-histidine in an amount of about 3.5% to about 6.7% by weight; and(d) mannitol in an amount of about 63.15% to about 88.65% by weight.

[0346] In some embodiments, the pharmaceutical composition comprises:(a) apraglutide in an amount of about 8% to about 25% by weight of total solids; (b) glycine in an amount of about 0.75% to about 4.25% by weight;(c) L-histidine in an amount of about 4.35% to about 5.85% by weight; and(d) mannitol in an amount of about 63.15% to about 88.65% by weight.

[0347] In some embodiments, the pharmaceutical composition comprises:(a) apraglutide in an amount of about 8% to about 25% by weight of total solids; (b) glycine in an amount of about 0.75% to about 4.25% by weight;(c) L-histidine in an amount of about 4.9% to about 5.3% by weight; and(d) mannitol in an amount of about 63.15% to about 88.65% by weight.

[0348] In some embodiments, the pharmaceutical composition comprises:(a) apraglutide in an amount of about 8% to about 25% by weight of total solids; (b) glycine in an amount of about 0.75% to about 4.25% by weight;(c) L-histidine in an amount of about 5.1% by weight; and(d) mannitol in an amount of about 63.15% to about 88.65% by weight.

[0349] In some embodiments, the pharmaceutical composition comprises:(a) apraglutide in an amount of about 10% to about 23% by weight of total solids; (b) glycine in an amount of about 0.75% to about 4.25% by weight;(c) L-histidine in an amount of about 3.5% to about 6.7% by weight; and(d) mannitol in an amount of about 63.15% to about 88.65% by weight.

[0350] In some embodiments, the pharmaceutical composition comprises:(a) apraglutide in an amount of about 10% to about 23% by weight of total solids; (b) glycine in an amount of about 0.75% to about 4.25% by weight;(c) L-histidine in an amount of about 4.35% to about 5.85% by weight; and(d) mannitol in an amount of about 63.15% to about 88.65% by weight.

[0351] In some embodiments, the pharmaceutical composition comprises:(a) apraglutide in an amount of about 10% to about 23% by weight of total solids; (b) glycine in an amount of about 0.75% to about 4.25% by weight;(c) L-histidine in an amount of about 4.9% to about 5.3% by weight; and(d) mannitol in an amount of about 63.15% to about 88.65% by weight.VECT-007 / 001WO (43765-02067)

[0352] In some embodiments, the pharmaceutical composition comprises:(a) apraglutide in an amount of about 10% to about 23% by weight of total solids; (b) glycine in an amount of about 0.75% to about 4.25% by weight;(c) L-histidine in an amount of about 5.1% by weight; and(d) mannitol in an amount of about 63.15% to about 88.65% by weight.

[0353] In some embodiments, the pharmaceutical composition comprises:(a) apraglutide in an amount of about 14% to about 19% by weight of total solids; (b) glycine in an amount of about 0.75% to about 4.25% by weight;(c) L-histidine in an amount of about 3.5% to about 6.7% by weight; and(d) mannitol in an amount of about 63.15% to about 88.65% by weight.

[0354] In some embodiments, the pharmaceutical composition comprises:(a) apraglutide in an amount of about 14% to about 19% by weight of total solids; (b) glycine in an amount of about 0.75% to about 4.25% by weight;(c) L-histidine in an amount of about 4.35% to about 5.85% by weight; and(d) mannitol in an amount of about 63.15% to about 88.65% by weight.

[0355] In some embodiments, the pharmaceutical composition comprises:(a) apraglutide in an amount of about 14% to about 19% by weight of total solids; (b) glycine in an amount of about 0.75% to about 4.25% by weight;(c) L-histidine in an amount of about 4.9% to about 5.3% by weight; and(d) mannitol in an amount of about 63.15% to about 88,65% by weight,

[0356] In some embodiments, the pharmaceutical composition comprises:(a) apraglutide in an amount of about 14% to about 19% by weight of total solids; (b) glycine in an amount of about 0.75% to about 4.25% by weight;(c) L-histidine in an amount of about 5,1% by weight; and(d) mannitol in an amount of about 63.15% to about 88.65% by weight.

[0357] In some embodiments, the pharmaceutical composition comprises:(a) apraglutide in an amount of about 15.5% to about 17.5% by weight of total solids; (b) glycine in an amount of about 0.75% to about 4.25% by weight;(c) L-histidine in an amount of about 3.5% to about 6.7% by weight; and(d) mannitol in an amount of about 63.15% to about 88.65% by weight.

[0358] In some embodiments, the pharmaceutical composition comprises:(a) apraglutide in an amount of about 15.5% to about 17.5% by weight of total solids; (b) glycine in an amount of about 0.75% to about 4.25% by weight;(c) L-histidine in an amount of about 4.35% to about 5.85% by weight; andVECT-007 / 001WO (43765-02067)(d) mannitol in an amount of about 63.15% to about 88.65% by weight.

[0359] In some embodiments, the pharmaceutical composition comprises:(a) apraglutide in an amount of about 15.5% to about 17.5% by weight of total solids; (b) glycine in an amount of about 0.75% to about 4.25% by weight;(c) L-histidine in an amount of about 4.9% to about 5.3% by weight; and(d) mannitol in an amount of about 63.15% to about 88,65% by weight.

[0360] In some embodiments, the pharmaceutical composition comprises:(a) apraglutide in an amount of about 15.5% to about 17.5% by weight of total solids; (b) glycine in an amount of about 0.75% to about 4.25% by weight;(c) L-histidine in an amount of about 5.1% by weight; and(d) mannitol in an amount of about 63.15% to about 88.65% by weight.

[0361] In some embodiments, the pharmaceutical composition comprises:(a) apraglutide in an amount of about 16,5% by weight of total solids;(b) glycine in an amount of about 0.75% to about 4.25% by weight;(c) L-histidine in an amount of about 3.5% to about 6.7% by weight; and(d) mannitol in an amount of about 63.15% to about 88.65% by weight.

[0362] In some embodiments, the pharmaceutical composition comprises:(a) apraglutide in an amount of about 16.5% by weight of total solids;(b) glycine in an amount of about 0.75% to about 4.25% by weight;(c) L-histidine in an amount of about 4.35% to about 5,85% by weight; and(d) mannitol in an amount of about 63.15% to about 88.65% by weight.

[0363] In some embodiments, the pharmaceutical composition comprises:(a) apraglutide in an amount of about 16.5% by weight of total solids;(b) glycine in an amount of about 0.75% to about 4.25% by weight;(c) L-histidine in an amount of about 4.9% to about 5.3% by weight; and(d) mannitol in an amount of about 63.15% to about 88.65% by weight.

[0364] In some embodiments, the pharmaceutical composition comprises:(a) apraglutide in an amount of about 16.5% by weight of total solids;(b) glycine in an amount of about 0.75% to about 4.25% by weight;(c) L-histidine in an amount of about 5.1% by weight; and(d) mannitol in an amount of about 63.15% to about 88.65% by weight.

[0365] In some embodiments, the pharmaceutical composition comprises:(a) apraglutide in an amount of about 8% to about 25% by weight of total solids; (b) glycine in an amount of about 0.75% to about 4.25% by weight;VECT-007 / 001WO (43765-02067)(c) L-histidine in an amount of about 2.55% to about 7.65% by weight; and(d) mannitol in an amount of about 69.15% to about 82.65% by weight.

[0366] In some embodiments, the pharmaceutical composition comprises:(a) apraglutide in an amount of about 8% to about 25% by weight of total solids; (b) glycine in an amount of about 0.75% to about 4.25% by weight;(c) L-histidine in an amount of about 2.55% to about 7,65% by weight; and(d) mannitol in an amount of about 72.9% to about 78.9% by weight.

[0367] In some embodiments, the pharmaceutical composition comprises:(a) apraglutide in an amount of about 8% to about 25% by weight of total solids; (b) glycine in an amount of about 0.75% to about 4.25% by w 'eight;(c) L-histidine in an amount of about 2.55% to about 7.65% by weight; and(d) mannitol in an amount of about 74.9% to about 76.9% by weight.

[0368] In some embodiments, the pharmaceutical composition comprises:(a) apraglutide in an amount of about 8% to about 25% by weight of total solids; (b) glycine in an amount of about 0.75% to about 4.25% by weight;(c) L-histidine in an amount of about 2.55% to about 7.65% by weight; and(d) mannitol in an amount of about 75.9% by weight.

[0369] In some embodiments, the pharmaceutical composition comprises:(a) apraglutide in an amount of about 10% to about 23% by weight of total solids; (b) glycine in an amount of about 0.75% to about 4.25% by weight;(c) L-histidine in an amount of about 2.55% to about 7.65% by weight; and(d) mannitol in an amount of about 69.15% to about 82.65% by weight.

[0370] In some embodiments, the pharmaceutical composition comprises:(a) apraglutide in an amount of about 10% to about 23% by weight of total solids; (b) glycine in an amount of about 0.75% to about 4.25% by w 'eight;(c) L-histidine in an amount of about 2.55% to about 7.65% by weight; and(d) mannitol in an amount of about 72.9% to about 78.9% by weight.

[0371] In some embodiments, the pharmaceutical composition comprises:(a) apraglutide in an amount of about 10% to about 23% by weight of total solids; (b) glycine in an amount of about 0.75% to about 4.25% by weight;(c) L-histidine in an amount of about 2,55% to about 7.65% by weight; and(d) mannitol in an amount of about 74.9% to about 76.9% by weight.

[0372] In some embodiments, the pharmaceutical composition comprises:(a) apraglutide in an amount of about 10% to about 23% by weight of total solids;VECT-007 / 001WO (43765-02067)(b) glycine in an amount of about 0.75% to about 4.25% by weight;(c) L-histidine in an amount of about 2.55% to about 7.65% by weight; and(d) mannitol in an amount of about 75.9% by weight.

[0373] In some embodiments, the pharmaceutical composition comprises:(a) apraglutide in an amount of about 14% to about 19% by weight of total solids; (b) glycine in an amount of about 0.75% to about 4.25% by weight;(c) L-histidine in an amount of about 2.55% to about 7.65% by weight; and(d) mannitol in an amount of about 69.15% to about 82.65% by weight.

[0374] In some embodiments, the pharmaceutical composition comprises:(a) apraglutide in an amount of about 14% to about 19% by weight of total solids; (b) glycine in an amount of about 0.75% to about 4.25% by weight;(c) L-histidine in an amount of about 2.55% to about 7.65% by weight; and(d) mannitol in an amount of about 72.9% to about 78.9% by weight.

[0375] In some embodiments, the pharmaceutical composition comprises:(a) apraglutide in an amount of about 14% to about 19% by weight of total solids; (b) glycine in an amount of about 0.75% to about 4.25% by weight;(c) L-histidine in an amount of about 2,55% to about 7.65% by weight; and(d) mannitol in an amount of about 74.9% to about 76.9% by weight.

[0376] In some embodiments, the pharmaceutical composition comprises:(a) apraglutide in an amount of about 14% to about 19% by weight of total solids; (b) glycine in an amount of about 0.75% to about 4.25% by weight;(c) L-histidine in an amount of about 2.55% to about 7.65% by weight; and(d) mannitol in an amount of about 75.9% by weight.

[0377] In some embodiments, the pharmaceutical composition comprises:(a) apraglutide in an amount of about 15.5% to about 17.5% by weight of total solids; (b) glycine in an amount of about 0.75% to about 4.25% by weight;(c) L-histidine in an amount of about 2.55% to about 7,65% by weight; and(d) mannitol in an amount of about 69.15% to about 82.65% by weight.

[0378] In some embodiments, the pharmaceutical composition comprises:(a) apraglutide in an amount of about 15.5% to about 17.5% by weight of total solids; (b) glycine in an amount of about 0.75% to about 4.25% by weight;(c) L-histidine in an amount of about 2.55% to about 7.65% by weight; and(d) mannitol in an amount of about 72.9% to about 78.9% by weight.

[0379] In some embodiments, the pharmaceutical composition comprises:VECT-007 / 001WO (43765-02067)(a) apraglutide in an amount of about 15.5% to about 17.5% by weight of total solids; (b) glycine in an amount of about 0.75% to about 4.25% by weight;(c) L-histidine in an amount of about 2.55% to about 7.65% by weight; and(d) mannitol in an amount of about 74.9% to about 76.9% by weight.

[0380] In some embodiments, the pharmaceutical composition comprises:(a) apraglutide in an amount of about 15.5% to about 17.5% by weight of total solids; (b) glycine in an amount of about 0.75% to about 4.25% by weight;(c) L-histidine in an amount of about 2.55% to about 7.65% by weight; and(d) mannitol in an amount of about 75.9% by weight.

[0381] In some embodiments, the pharmaceutical composition comprises:(a) apraglutide in an amount of about 16.5% by weight of total solids;(b) glycine in an amount of about 0.75% to about 4.25% by weight;(c) L-histidine in an amount of about 2.55% to about 7,65% by weight; and(d) mannitol in an amount of about 69.15% to about 82.65% by weight.

[0382] In some embodiments, the pharmaceutical composition comprises:(a) apraglutide in an amount of about 16.5% by weight of total solids;(b) glycine in an amount of about 0.75% to about 4.25% by weight;(c) L-histidine in an amount of about 2.55% to about 7.65% by weight; and(d) mannitol in an amount of about 72.9% to about 78.9% by weight.

[0383] In some embodiments, the pharmaceutical composition comprises:(a) apraglutide in an amount of about 16.5% by weight of total solids;(b) glycine in an amount of about 0.75% to about 4.25% by weight;(c) L-histidine in an amount of about 2.55% to about 7.65% by weight; and(d) mannitol in an amount of about 74.9% to about 76.9% by weight,

[0384] In some embodiments, the pharmaceutical composition comprises:(a) apraglutide in an amount of about 16.5% by weight of total solids;(b) glycine in an amount of about 0.75% to about 4.25% by weight;(c) L-histidine in an amount of about 2.55% to about 7.65% by weight; and(d) mannitol in an amount of about 75.9% by weight.

[0385] In some embodiments, the pharmaceutical composition comprises:(a) apraglutide in an amount of about 0.4 mol% to about 1.4 mol%;(b) a buffering agent in an amount of about 3.39 mol% to about 10.16 mol%;(c) a stabilizing agent in an amount of about 3.39 mol% to about 10.16 mol%; and (d) a bulking agent in an amount of about 77.99 mol% to about 93.16 mol%.VECT-007 / 001WO (43765-02067)

[0386] In some embodiments, the pharmaceutical composition comprises:(a) apraglutide in an amount of about 0.5 mol% to about 1.3 mol%;(b) a buffering agent in an amount of about 3.39 mol% to about 10.16 mol%;(c) a stabilizing agent in an amount of about 3.39 mol% to about 10.16 mol%; and (d) a bulking agent in an amount of about 77.99 mol% to about 93.16 mol%.

[0387] In some embodiments, the pharmaceutical composition comprises:(a) apraglutide in an amount of about 0.7 mol% to about 1.1 mol%;(b) a buffering agent in an amount of about 3.39 mol% to about 10.16 mol%;(c) a stabilizing agent in an amount of about 3.39 mol% to about 10.16 mol%; and (d) a bulking agent in an amount of about 77.99 mol% to about 93.16 mol%.

[0388] In some embodiments, the pharmaceutical composition comprises:(a) apraglutide in an amount of about 0.8 mol% to about 1.0 mol%;(b) a buffering agent in an amount of about 3.39 mol% to about 10.16 mol%;(c) a stabilizing agent in an amount of about 3.39 mol% to about 10.16 mol%; and (d) a bulking agent in an amount of about 77.99 mol% to about 93.16 mol%.

[0389] In some embodiments, the pharmaceutical composition comprises:(a) apraglutide in an amount of about 0.9 mol%;(b) a buffering agent in an amount of about 3.39 mol% to about 10.16 mol%;(c) a stabilizing agent in an amount of about 3.39 mol% to about 10.16 mol%; and (d) a bulking agent in an amount of about 77.99 mol% to about 93.16 mol%.

[0390] In some embodiments, the pharmaceutical composition comprises:(a) apraglutide in an amount of about 0.4 mol% to about 1.4 mol%;(b) a buffering agent in an amount of about 4.77 mol% to about 8.77 mol%;(c) a stabilizing agent in an amount of about 3.39 mol% to about 10,16 mol%; and (d) a bulking agent in an amount of about 77.99 mol% to about 93.16 mol%.

[0391] In some embodiments, the pharmaceutical composition comprises:(a) apraglutide in an amount of about 0.4 mol% to about 1,4 mol%;(b) a buffering agent in an amount of about 5.77 mol% to about 7.77 mol%;(c) a stabilizing agent in an amount of about 3.39 mol% to about 10.16 mol%; and (d) a bulking agent in an amount of about 77.99 mol% to about 93.16 mol%.

[0392] In some embodiments, the pharmaceutical composition comprises:(a) apraglutide in an amount of about 0.4 mol% to about 1.4 mol%;(b) a buffering agent in an amount of about 6.47 mol% to about 7.07 mol%;(c) a stabilizing agent in an amount of about 3.39 mol% to about 10.16 mol%; andVECT-007 / 001WO (43765-02067)(d) a bulking agent in an amount of about 77.99 mol% to about 93.16 mol%.

[0393] In some embodiments, the pharmaceutical composition comprises:(a) apraglutide in an amount of about 0.4 mol% to about 1.4 mol%;(b) a buffering agent in an amount of about 6.77 mol%;(c) a stabilizing agent in an amount of about 3.39 mol% to about 10.16 mol%; and (d) a bulking agent in an amount of about 77.99 mol% to about 93.16 mol%.

[0394] In some embodiments, the pharmaceutical composition comprises:(a) apraglutide in an amount of about 0.5 mol% to about 1.3 mol%;(b) a buffering agent in an amount of about 4.77 mol% to about 8.77 mol%;(c) a stabilizing agent in an amount of about 3.39 mol% to about 10.16 mol%; and (d) a bulking agent in an amount of about 77.99 mol% to about 93.16 mol%.

[0395] In some embodiments, the pharmaceutical composition comprises:(a) apraglutide in an amount of about 0.5 mol% to about 1.3 mol%;(b) a buffering agent in an amount of about 5.77 mol% to about 7.77 mol%;(c) a stabilizing agent in an amount of about 3.39 mol% to about 10.16 mol%; and (d) a bulking agent in an amount of about 77.99 mol% to about 93.16 mol%.

[0396] In some embodiments, the pharmaceutical composition comprises:(a) apraglutide in an amount of about 0.5 mol% to about 1.3 mol%;(b) a buffering agent in an amount of about 6.47 mol% to about 7.07 mol%;(c) a stabilizing agent in an amount of about 3.39 mol% to about 10.16 mol%; and (d) a bulking agent in an amount of about 77.99 mol% to about 93.16 mol%.

[0397] In some embodiments, the pharmaceutical composition comprises:(a) apraglutide in an amount of about 0.5 mol% to about 1.3 mol%;(b) a buffering agent in an amount of about 6.77 mol%;(c) a stabilizing agent in an amount of about 3.39 mol% to about 10.16 mol%; and (d) a bulking agent in an amount of about 77.99 mol% to about 93.16 mol%.

[0398] In some embodiments, the pharmaceutical composition comprises:(a) apraglutide in an amount of about 0.7 mol% to about 1.1 mol%;(b) a buffering agent in an amount of about 4.77 mol% to about 8.77 mol%;(c) a stabilizing agent in an amount of about 3.39 mol% to about 10.16 mol%; and (d) a bulking agent in an amount of about 77.99 mol% to about 93.16 mol%.

[0399] In some embodiments, the pharmaceutical composition comprises:(a) apraglutide in an amount of about 0.7 mol% to about 1.1 mol%;(b) a buffering agent in an amount of about 5.77 mol% to about 7.77 mol%;VECT-007 / 001WO (43765-02067)(c) a stabilizing agent in an amount of about 3.39 mol% to about 10.16 mol%; and (d) a bulking agent in an amount of about 77.99 mol% to about 93.16 mol%.

[0400] In some embodiments, the pharmaceutical composition comprises:(a) apraglutide in an amount of about 0.7 mol% to about 1.1 mol%;(b) a buffering agent in an amount of about 6.47 mol% to about 7.07 mol%;(c) a stabilizing agent in an amount of about 3.39 mol% to about 10.16 mol%; and (d) a bulking agent in an amount of about 77.99 mol% to about 93.16 mol%.

[0401] In some embodiments, the pharmaceutical composition comprises:(a) apraglutide in an amount of about 0.7 mol% to about 1.1 mol%;(b) a buffering agent in an amount of about 6.77 mol%;(c) a stabilizing agent in an amount of about 3.39 mol% to about 10.16 mol%; and (d) a bulking agent in an amount of about 77.99 mol% to about 93.16 mol%.

[0402] In some embodiments, the pharmaceutical composition comprises:(a) apraglutide in an amount of about 0.8 mol% to about 1.0 mol%;(b) a buffering agent in an amount of about 4.77 mol% to about 8.77 mol%;(c) a stabilizing agent in an amount of about 3.39 mol% to about 10.16 mol%; and (d) a bulking agent in an amount of about 77.99 mol% to about 93.16 mol%.

[0403] In some embodiments, the pharmaceutical composition comprises:(a) apraglutide in an amount of about 0.8 mol% to about 1.0 mol%;(b) a buffering agent in an amount of about 5.77 mol% to about 7.77 mol%;(c) a stabilizing agent in an amount of about 3.39 mol% to about 10.16 mol%; and (d) a bulking agent in an amount of about 77.99 mol% to about 93.16 mol%.

[0404] In some embodiments, the pharmaceutical composition comprises:(a) apraglutide in an amount of about 0.8 mol% to about 1.0 mol%;(b) a buffering agent in an amount of about 6.47 mol% to about 7.07 mol%;(c) a stabilizing agent in an amount of about 3.39 mol% to about 10.16 mol%; and (d) a bulking agent in an amount of about 77.99 mol% to about 93.16 mol%.

[0405] In some embodiments, the pharmaceutical composition comprises:(a) apraglutide in an amount of about 0.8 mol% to about 1.0 mol%;(b) a buffering agent in an amount of about 6.77 mol%;(c) a stabilizing agent in an amount of about 3.39 mol% to about 10.16 mol%; and (d) a bulking agent in an amount of about 77.99 mol% to about 93.16 mol%.

[0406] In some embodiments, the pharmaceutical composition comprises:(a) apraglutide in an amount of about 0.9 mol%;VECT-007 / 001WO (43765-02067)(b) a buffering agent in an amount of about 4.77 mol% to about 8.77 mol%;(c) a stabilizing agent in an amount of about 3.39 mol% to about 10.16 mol%; and (d) a bulking agent in an amount of about 77.99 mol% to about 93.16 mol%.

[0407] In some embodiments, the pharmaceutical composition comprises:(a) apraglutide in an amount of about 0.9 mol%;(b) a buffering agent in an amount of about 5.77 mol% to about 7.77 mol%;(c) a stabilizing agent in an amount of about 3.39 mol% to about 10.16 mol%; and (d) a bulking agent in an amount of about 77.99 mol% to about 93.16 mol%.

[0408] In some embodiments, the pharmaceutical composition comprises:(a) apraglutide in an amount of about 0.9 mol%;(b) a buffering agent in an amount of about 6.47 mol% to about 7.07 mol%;(c) a stabilizing agent in an amount of about 3.39 mol% to about 10.16 mol%; and (d) a bulking agent in an amount of about 77.99 mol% to about 93.16 mol%.

[0409] In some embodiments, the pharmaceutical composition comprises:(a) apraglutide in an amount of about 0.9 mol%;(b) a buffering agent in an amount of about 6.77 mol%;(c) a stabilizing agent in an amount of about 3.39 mol% to about 10.16 mol%; and (d) a bulking agent in an amount of about 77.99 mol% to about 93.16 mol%.

[0410] In some embodiments, the pharmaceutical composition comprises:(a) apraglutide in an amount of about 0.4 mol% to about 1.4 mol%;(b) a buffering agent in an amount of about 3.39 mol% to about 10.16 mol%;(c) a stabilizing agent in an amount of about 4.76 mol% to about 8.76 mol%; and (d) a bulking agent in an amount of about 77.99 mol% to about 93.16 mol%.

[0411] In some embodiments, the pharmaceutical composition comprises:(a) apraglutide in an amount of about 0.4 mol% to about 1.4 mol%;(b) a buffering agent in an amount of about 3.39 mol% to about 10.16 mol%;(c) a stabilizing agent in an amount of about 5.76 mol% to about 7.76 mol%; and (d) a bulking agent in an amount of about 77.99 mol% to about 93.16 mol%.

[0412] In some embodiments, the pharmaceutical composition comprises:(a) apraglutide in an amount of about 0.4 mol% to about 1.4 mol%;(b) a buffering agent in an amount of about 3.39 mol% to about 10.16 mol%;(c) a stabilizing agent in an amount of about 6.46 mol% to about 7.06 mol%; and (d) a bulking agent in an amount of about 77.99 mol% to about 93.16 mol%.

[0413] In some embodiments, the pharmaceutical composition comprises:VECT-007 / 001WO (43765-02067)(a) apraglutide in an amount of about 0.4 mol%to about 1.4 mol%;(b) a buffering agent in an amount of about 3.39 mol% to about 10.16 mol%;(c) a stabilizing agent in an amount of about 6.76 mol%; and(d) a bulking agent in an amount of about 77.99 mol% to about 93.16 mol%.

[0414] In some embodiments, the pharmaceutical composition comprises:(a) apraglutide in an amount of about 0.5 mol% to about 1.3 mol%;(b) a buffering agent in an amount of about 3.39 mol% to about 10.16 mol%;(c) a stabilizing agent in an amount of about 4.76 mol% to about 8.76 mol%; and (d) a bulking agent in an amount of about 77.99 mol% to about 93.16 mol%.

[0415] In some embodiments, the pharmaceutical composition comprises:(a) apraglutide in an amount of about 0.5 mol% to about 1.3 mol%;(b) a buffering agent in an amount of about 3.39 mol% to about 10.16 mol%;(c) a stabilizing agent in an amount of about 5.76 mol% to about 7.76 mol%; and (d) a bulking agent in an amount of about 77.99 mol% to about 93.16 mol%.

[0416] In some embodiments, the pharmaceutical composition comprises:(a) apraglutide in an amount of about 0.5 mol% to about 1.3 mol%;(b) a buffering agent in an amount of about 3.39 mol% to about 10.16 mol%;(c) a stabilizing agent in an amount of about 6.46 mol% to about 7.06 mol%; and (d) a bulking agent in an amount of about 77.99 mol% to about 93.16 mol%.

[0417] In some embodiments, the pharmaceutical composition comprises:(a) apraglutide in an amount of about 0.5 mol% to about 1.3 mol%;(b) a buffering agent in an amount of about 3.39 mol% to about 10.16 mol%;(c) a stabilizing agent in an amount of about 6.76 mol%; and(d) a bulking agent in an amount of about 77.99 mol% to about 93.16 mol%.

[0418] In some embodiments, the pharmaceutical composition comprises:(a) apraglutide in an amount of about 0.7 mol% to about 1.1 mol%;(b) a buffering agent in an amount of about 3.39 mol% to about 10.16 mol%;(c) a stabilizing agent in an amount of about 4.76 mol% to about 8.76 mol%; and (d) a bulking agent in an amount of about 77.99 mol%to about 93.16 mol%.

[0419] In some embodiments, the pharmaceutical composition comprises:(a) apraglutide in an amount of about 0.7 mol% to about 1.1 mol%;(b) a buffering agent in an amount of about 3.39 mol% to about 10.16 mol%;(c) a stabilizing agent in an amount of about 5.76 mol% to about 7.76 mol%; and (d) a bulking agent in an amount of about 77.99 mol% to about 93.16 mol%.VECT-007 / 001WO (43765-02067)

[0420] In some embodiments, the pharmaceutical composition comprises:(a) apraglutide in an amount of about 0.7 mol% to about 1.1 mol%;(b) a buffering agent in an amount of about 3.39 mol% to about 10.16 mol%;(c) a stabilizing agent in an amount of about 6.46 mol% to about 7.06 mol%; and (d) a bulking agent in an amount of about 77.99 mol% to about 93.16 mol%.

[0421] In some embodiments, the pharmaceutical composition comprises:(a) apraglutide in an amount of about 0.7 mol% to about 1.1 mol%;(b) a buffering agent in an amount of about 3.39 mol% to about 10.16 mol%;(c) a stabilizing agent in an amount of about 6.76 mol%; and(d) a bulking agent in an amount of about 77.99 mol% to about 93.16 mol%.

[0422] In some embodiments, the pharmaceutical composition comprises:(a) apraglutide in an amount of about 0.8 mol% to about 1.0 mol%;(b) a buffering agent in an amount of about 3.39 mol% to about 10.16 mol%;(c) a stabilizing agent in an amount of about 4.76 mol% to about 8.76 mol%; and (d) a bulking agent in an amount of about 77.99 mol%to about 93.16 mol%.

[0423] In some embodiments, the pharmaceutical composition comprises:(a) apraglutide in an amount of about 0.8 mol% to about 1.0 mol%;(b) a buffering agent in an amount of about 3.39 mol% to about 10.16 mol%;(c) a stabilizing agent in an amount of about 5.76 mol% to about 7.76 mol%; and (d) a bulking agent in an amount of about 77.99 mol% to about 93.16 mol%.

[0424] In some embodiments, the pharmaceutical composition comprises:(a) apraglutide in an amount of about 0.8 mol% to about 1.0 mol%;(b) a buffering agent in an amount of about 3.39 mol% to about 10.16 mol%;(c) a stabilizing agent in an amount of about 6.46 mol% to about 7.06 mol%; and (d) a bulking agent in an amount of about 77.99 mol% to about 93.16 mol%.

[0425] In some embodiments, the pharmaceutical composition comprises:(a) apraglutide in an amount of about 0.8 mol% to about 1.0 mol%;(b) a buffering agent in an amount of about 3.39 mol% to about 10.16 mol%;(c) a stabilizing agent in an amount of about 6.76 mol%; and(d) a bulking agent in an amount of about 77.99 mol% to about 93.16 mol%.

[0426] In some embodiments, the pharmaceutical composition comprises:(a) apraglutide in an amount of about 0.9 mol%;(b) a buffering agent in an amount of about 3.39 mol% to about 10.16 mol%;(c) a stabilizing agent in an amount of about 4.76 mol% to about 8.76 mol%; andVECT-007 / 001WO (43765-02067)(d) a bulking agent in an amount of about 77.99 mol% to about 93.16 mol%.

[0427] In some embodiments, the pharmaceutical composition comprises:(a) apraglutide in an amount of about 0.9 mol%;(b) a buffering agent in an amount of about 3.39 mol% to about 10.16 mol%;(c) a stabilizing agent in an amount of about 5.76 mol% to about 7.76 mol%; and (d) a bulking agent in an amount of about 77.99 mol% to about 93.16 mol%.

[0428] In some embodiments, the pharmaceutical composition comprises:(a) apraglutide in an amount of about 0.9 mol%;(b) a buffering agent in an amount of about 3.39 mol% to about 10.16 mol%;(c) a stabilizing agent in an amount of about 6.46 mol% to about 7.06 mol%; and (d) a bulking agent in an amount of about 77.99 mol% to about 93.16 mol%.

[0429] In some embodiments, the pharmaceutical composition comprises:(a) apraglutide in an amount of about 0.9 mol%;(b) a buffering agent in an amount of about 3.39 mol% to about 10.16 mol%;(c) a stabilizing agent in an amount of about 6.76 mol%; and(d) a bulking agent in an amount of about 77.99 mol% to about 93.16 mol%.

[0430] In some embodiments, the pharmaceutical composition comprises:(a) apraglutide in an amount of about 0.4 mol% to about 1.4 mol%;(b) a buffering agent in an amount of about 3.39 mol% to about 10.16 mol%;(c) a stabilizing agent in an amount of about 3.39 mol% to about 10.16 mol%; and (d) a bulking agent in an amount of about 81.57 mol% to about 89.57 mol%.

[0431] In some embodiments, the pharmaceutical composition comprises:(a) apraglutide in an amount of about 0.4 mol% to about 1.4 mol%;(b) a buffering agent in an amount of about 3.39 mol% to about 10.16 mol%;(c) a stabilizing agent in an amount of about 3.39 mol% to about 10.16 mol%; and (d) a bulking agent in an amount of about 83.57 mol% to about 87.57 mol%.

[0432] In some embodiments, the pharmaceutical composition comprises:(a) apraglutide in an amount of about 0.4 mol% to about 1.4 mol%;(b) a buffering agent in an amount of about 3.39 mol% to about 10.16 mol%;(c) a stabilizing agent in an amount of about 3.39 mol% to about 10.16 mol%; and (d) a bulking agent in an amount of about 84.90 mol% to about 86.27 mol%.

[0433] In some embodiments, the pharmaceutical composition comprises:(a) apraglutide in an amount of about 0.4 mol% to about 1.4 mol%;(b) a buffering agent in an amount of about 3.39 mol% to about 10.16 mol%;VECT-007 / 001WO (43765-02067)(c) a stabilizing agent in an amount of about 3.39 mol% to about 10.16 mol%; and (d) a bulking agent in an amount of about 85.57 mol%.

[0434] In some embodiments, the pharmaceutical composition comprises:(a) apraglutide in an amount of about 0.5 mol% to about 1.3 mol%;(b) a buffering agent in an amount of about 3.39 mol% to about 10.16 mol%;(c) a stabilizing agent in an amount of about 3.39 mol% to about 10.16 mol%; and (d) a bulking agent in an amount of about 81.57 mol% to about 89.57 mol%.

[0435] In some embodiments, the pharmaceutical composition comprises:(a) apraglutide in an amount of about 0.5 mol% to about 1.3 mol%;(b) a buffering agent in an amount of about 3.39 mol% to about 10.16 mol%;(c) a stabilizing agent in an amount of about 3.39 mol% to about 10.16 mol%; and (d) a bulking agent in an amount of about 83.57 mol% to about 87.57 mol%.

[0436] In some embodiments, the pharmaceutical composition comprises:(a) apraglutide in an amount of about 0.5 mol% to about 1.3 mol%;(b) a buffering agent in an amount of about 3.39 mol% to about 10.16 mol%;(c) a stabilizing agent in an amount of about 3.39 mol% to about 10.16 mol%; and (d) a bulking agent in an amount of about 84.90 mol% to about 86.27 mol%,

[0437] In some embodiments, the pharmaceutical composition comprises:(a) apraglutide in an amount of about 0.5 mol% to about 1.3 mol%;(b) a buffering agent in an amount of about 3.39 mol% to about 10.16 mol%;(c) a stabilizing agent in an amount of about 3.39 mol% to about 10.16 mol%; and (d) a bulking agent in an amount of about 85.57 mol%.

[0438] In some embodiments, the pharmaceutical composition comprises:(a) apraglutide in an amount of about 0.7 mol% to about 1.1 mol%;(b) a buffering agent in an amount of about 3.39 mol% to about 10.16 mol%;(c) a stabilizing agent in an amount of about 3.39 mol% to about 10.16 mol%; and (d) a bulking agent in an amount of about 81.57 mol% to about 89.57 mol%.

[0439] In some embodiments, the pharmaceutical composition comprises:(a) apraglutide in an amount of about 0.7 mol% to about 1.1 mol%;(b) a buffering agent in an amount of about 3.39 mol% to about 10.16 mol%;(c) a stabilizing agent in an amount of about 3.39 mol% to about 10.16 mol%; and (d) a bulking agent in an amount of about 83.57 mol% to about 87.57 mol%.

[0440] In some embodiments, the pharmaceutical composition comprises:(a) apraglutide in an amount of about 0.7 mol% to about 1.1 mol%;VECT-007 / 001WO (43765-02067)(b) a buffering agent in an amount of about 3.39 mol% to about 10.16 mol%;(c) a stabilizing agent in an amount of about 3.39 mol% to about 10.16 mol%; and (d) a bulking agent in an amount of about 84.90 mol% to about 86.27 mol%.

[0441] In some embodiments, the pharmaceutical composition comprises:(a) apraglutide in an amount of about 0.7 mol% to about 1.1 mol%;(b) a buffering agent in an amount of about 3.39 mol% to about 10.16 mol%;(c) a stabilizing agent in an amount of about 3.39 mol% to about 10.16 mol%; and (d) a bulking agent in an amount of about 85.57 mol%.

[0442] In some embodiments, the pharmaceutical composition comprises:(a) apraglutide in an amount of about 0.8 mol% to about 1.0 mol%;(b) a buffering agent in an amount of about 3.39 mol% to about 10.16 mol%;(c) a stabilizing agent in an amount of about 3.39 mol% to about 10.16 mol%; and (d) a bulking agent in an amount of about 81.57 mol% to about 89.57 mol%.

[0443] In some embodiments, the pharmaceutical composition comprises:(a) apraglutide in an amount of about 0.8 mol% to about 1.0 mol%;(b) a buffering agent in an amount of about 3.39 mol% to about 10.16 mol%;(c) a stabilizing agent in an amount of about 3.39 mol% to about 10.16 mol%; and (d) a bulking agent in an amount of about 83.57 mol% to about 87.57 mol%.

[0444] In some embodiments, the pharmaceutical composition comprises:(a) apraglutide in an amount of about 0.8 mol% to about 1.0 mol%;(b) a buffering agent in an amount of about 3.39 mol% to about 10.16 mol%;(c) a stabilizing agent in an amount of about 3.39 mol% to about 10.16 mol%; and (d) a bulking agent in an amount of about 84.90 mol% to about 86.27 mol%.

[0445] In some embodiments, the pharmaceutical composition comprises:(a) apraglutide in an amount of about 0.8 mol% to about 1.0 mol%;(b) a buffering agent in an amount of about 3.39 mol% to about 10.16 mol%;(c) a stabilizing agent in an amount of about 3.39 mol% to about 10.16 mol%; and (d) a bulking agent in an amount of about 85.57 mol%.

[0446] In some embodiments, the pharmaceutical composition comprises:(a) apraglutide in an amount of about 0.9 mol%;(b) a buffering agent in an amount of about 3.39 mol% to about 10.16 mol%;(c) a stabilizing agent in an amount of about 3.39 mol% to about 10.16 mol%; and (d) a bulking agent in an amount of about 81.57 mol% to about 89.57 mol%.

[0447] In some embodiments, the pharmaceutical composition comprises:VECT-007 / 001WO (43765-02067)(a) apraglutide in an amount of about 0.9 mol%;(b) a buffering agent in an amount of about 3.39 mol% to about 10.16 mol%;(c) a stabilizing agent in an amount of about 3.39 mol% to about 10.16 mol%; and (d) a bulking agent in an amount of about 83.57 mol% to about 87.57 mol%.

[0448] In some embodiments, the pharmaceutical composition comprises:(a) apraglutide in an amount of about 0.9 mol%;(b) a buffering agent in an amount of about 3.39 mol% to about 10.16 mol%;(c) a stabilizing agent in an amount of about 3.39 mol% to about 10.16 mol%; and (d) a bulking agent in an amount of about 84.90 mol% to about 86.27 mol%.

[0449] In some embodiments, the pharmaceutical composition comprises:(a) apraglutide in an amount of about 0.9 mol%;(b) a buffering agent in an amount of about 3.39 mol% to about 10.16 mol%;(c) a stabilizing agent in an amount of about 3.39 mol% to about 10.16 mol%; and (d) a bulking agent in an amount of about 85.57 mol%.

[0450] In some embodiments, the pharmaceutical composition comprises:(a) apraglutide in an amount of about 0.4 mol% to about 1.4 mol%;(b) glycine in an amount of about 3.39 mol% to about 10.16 mol%;(c) L-histidine in an amount of about 3.39 mol% to about 10.16 mol%; and(d) mannitol in an amount of about 77.99 mol% to about 93.16 mol%.

[0451] In some embodiments, the pharmaceutical composition comprises:(a) apraglutide in an amount of about 0.5 mol% to about 1.3 mol%;(b) glycine in an amount of about 3.39 mol% to about 10.16 mol%;(c) L-histidine in an amount of about 3.39 mol% to about 10.16 mol%; and(d) mannitol in an amount of about 77.99 mol% to about 93.16 mol%.

[0452] In some embodiments, the pharmaceutical composition comprises:(a) apraglutide in an amount of about 0.7 mol% to about 1.1 mol%;(b) glycine in an amount of about 3.39 mol% to about 10.16 mol%;(c) L-histidine in an amount of about 3.39 mol% to about 10.16 mol%; and(d) mannitol in an amount of about 77.99 mol% to about 93.16 mol%.

[0453] In some embodiments, the pharmaceutical composition comprises:(a) apraglutide in an amount of about 0.8 mol% to about 1.0 mol%;(b) glycine in an amount of about 3.39 mol% to about 10.16 mol%;(c) L-histidine in an amount of about 3.39 mol% to about 10.16 mol%; and(d) mannitol in an amount of about 77.99 mol% to about 93.16 mol%.VECT-007 / 001WO (43765-02067)

[0454] In some embodiments, the pharmaceutical composition comprises:(a) apraglutide in an amount of about 0.9 mol%;(b) glycine in an amount of about 3.39 mol% to about 10.16 mol%;(c) L-histidine in an amount of about 3.39 mol% to about 10.16 mol%; and(d) mannitol in an amount of about 77.99 mol% to about 93.16 mol%.

[0455] In some embodiments, the pharmaceutical composition comprises:(a) apraglutide in an amount of about 0.4 mol% to about 1.4 mol%;(b) glycine in an amount of about 4.77 mol% to about 8.77 mol%;(c) L-histidine in an amount of about 3.39 mol% to about 10.16 mol%; and(d) mannitol in an amount of about 77.99 mol% to about 93.16 mol%.

[0456] In some embodiments, the pharmaceutical composition comprises:(a) apraglutide in an amount of about 0.4 mol% to about 1.4 mol%;(b) glycine in an amount of about 5.77 mol% to about 7.77 mol%;(c) L-histidine in an amount of about 3.39 mol% to about 10.16 mol%; and(d) mannitol in an amount of about 77.99 mol% to about 93.16 mol%.

[0457] In some embodiments, the pharmaceutical composition comprises:(a) apraglutide in an amount of about 0.4 mol% to about 1.4 mol%;(b) glycine in an amount of about 6.47 mol% to about 7.07 mol%;(c) L-histidine in an amount of about 3.39 mol% to about 10.16 mol%; and(d) mannitol in an amount of about 77.99 mol% to about 93.16 mol%.

[0458] In some embodiments, the pharmaceutical composition comprises:(a) apraglutide in an amount of about 0.4 mol% to about 1.4 mol%;(b) glycine in an amount of about 6.77 mol%;(c) L-histidine in an amount of about 3.39 mol% to about 10.16 mol%; and(d) mannitol in an amount of about 77.99 mol% to about 93.16 mol%.

[0459] In some embodiments, the pharmaceutical composition comprises:(a) apraglutide in an amount of about 0.5 mol% to about 1.3 mol%;(b) glycine in an amount of about 4.77 mol% to about 8.77 mol%;(c) L-histidine in an amount of about 3.39 mol% to about 10.16 mol%; and(d) mannitol in an amount of about 77.99 mol% to about 93.16 mol%.

[0460] In some embodiments, the pharmaceutical composition comprises:(a) apraglutide in an amount of about 0.5 mol% to about 1.3 mol%;(b) glycine in an amount of about 5.77 mol% to about 7.77 mol%;(c) L-histidine in an amount of about 3.39 mol% to about 10.16 mol%; andVECT-007 / 001WO (43765-02067)(d) mannitol in an amount of about 77.99 mol% to about 93.16 mol%.

[0461] In some embodiments, the pharmaceutical composition comprises:(a) apraglutide in an amount of about 0.5 mol% to about 1.3 mol%;(b) glycine in an amount of about 6.47 mol% to about 7.07 mol%;(c) L-histidine in an amount of about 3.39 mol% to about 10.16 mol%; and(d) mannitol in an amount of about 77.99 mol% to about 93.16 mol%.

[0462] In some embodiments, the pharmaceutical composition comprises:(a) apraglutide in an amount of about 0.5 mol% to about 1.3 mol%;(b) glycine in an amount of about 6.77 mol%;(c) L-histidine in an amount of about 3.39 mol% to about 10.16 mol%; and(d) mannitol in an amount of about 77.99 mol% to about 93.16 mol%.

[0463] In some embodiments, the pharmaceutical composition comprises:(a) apraglutide in an amount of about 0.7 mol% to about 1.1 mol%;(b) glycine in an amount of about 4.77 mol% to about 8.77 mol%;(c) L-histidine in an amount of about 3.39 mol% to about 10.16 mol%; and(d) mannitol in an amount of about 77.99 mol% to about 93.16 mol%.

[0464] In some embodiments, the pharmaceutical composition comprises:(a) apraglutide in an amount of about 0.7 mol% to about 1.1 mol%;(b) glycine in an amount of about 5.77 mol% to about 7.77 mol%;(c) L-histidine in an amount of about 3.39 mol% to about 10.16 mol%; and(d) mannitol in an amount of about 77.99 mol% to about 93.16 mol%.

[0465] In some embodiments, the pharmaceutical composition comprises:(a) apraglutide in an amount of about 0.7 mol% to about 1.1 mol%;(b) glycine in an amount of about 6.47 mol% to about 7.07 mol%;(c) L-histidine in an amount of about 3.39 mol% to about 10.16 mol%; and(d) mannitol in an amount of about 77.99 mol% to about 93.16 mol%.

[0466] In some embodiments, the pharmaceutical composition comprises:(a) apraglutide in an amount of about 0.7 mol% to about 1.1 mol%;(b) glycine in an amount of about 6.77 mol%;(c) L-histidine in an amount of about 3.39 mol% to about 10.16 mol%; and(d) mannitol in an amount of about 77.99 mol% to about 93.16 mol%.

[0467] In some embodiments, the pharmaceutical composition comprises:(a) apraglutide in an amount of about 0.8 mol% to about 1.0 mol%;(b) glycine in an amount of about 4.77 mol% to about 8.77 mol%;VECT-007 / 001WO (43765-02067)(c) L-histidine in an amount of about 3.39 mol% to about 10.16 mol%; and(d) mannitol in an amount of about 77.99 mol% to about 93.16 mol%.

[0468] In some embodiments, the pharmaceutical composition comprises:(a) apraglutide in an amount of about 0.8 mol% to about 1.0 mol%;(b) glycine in an amount of about 5.77 mol% to about 7.77 mol%;(c) L-histidine in an amount of about 3.39 mol% to about 10.16 mol%; and(d) mannitol in an amount of about 77.99 mol% to about 93.16 mol%.

[0469] In some embodiments, the pharmaceutical composition comprises:(a) apraglutide in an amount of about 0.8 mol% to about 1.0 mol%;(b) glycine in an amount of about 6.47 mol% to about 7.07 mol%;(c) L-histidine in an amount of about 3.39 mol% to about 10.16 mol%; and(d) mannitol in an amount of about 77.99 mol% to about 93.16 mol%.

[0470] In some embodiments, the pharmaceutical composition comprises:(a) apraglutide in an amount of about 0.8 mol% to about 1.0 mol%;(b) glycine in an amount of about 6.77 mol%;(c) L-histidine in an amount of about 3.39 mol% to about 10.16 mol%; and(d) mannitol in an amount of about 77.99 mol% to about 93.16 mol%.

[0471] In some embodiments, the pharmaceutical composition comprises:(a) apraglutide in an amount of about 0.9 mol%;(b) glycine in an amount of about 4.77 mol% to about 8.77 mol%;(c) L-histidine in an amount of about 3.39 mol% to about 10.16 mol%; and(d) mannitol in an amount of about 77.99 mol% to about 93.16 mol%.

[0472] In some embodiments, the pharmaceutical composition comprises:(a) apraglutide in an amount of about 0.9 mol%;(b) glycine in an amount of about 5.77 mol% to about 7.77 mol%;(c) L-histidine in an amount of about 3.39 mol% to about 10.16 mol%; and(d) mannitol in an amount of about 77.99 mol% to about 93.16 mol%.

[0473] In some embodiments, the pharmaceutical composition comprises:(a) apraglutide in an amount of about 0.9 mol%;(b) glycine in an amount of about 6.47 mol% to about 7.07 mol%;(c) L-histidine in an amount of about 3.39 mol% to about 10.16 mol%; and(d) mannitol in an amount of about 77.99 mol% to about 93.16 mol%.

[0474] In some embodiments, the pharmaceutical composition comprises:(a) apraglutide in an amount of about 0.9 mol%;VECT-007 / 001WO (43765-02067)(b) glycine in an amount of about 6.77 mol%;(c) L-histidine in an amount of about 3.39 mol% to about 10.16 mol%; and(d) mannitol in an amount of about 77.99 mol% to about 93.16 mol%.

[0475] In some embodiments, the pharmaceutical composition comprises:(a) apraglutide in an amount of about 0.4 mol% to about 1.4 mol%;(b) glycine in an amount of about 3.39 mol% to about 10.16 mol%;(c) L-histidine in an amount of about 4.77 mol% to about 8.77 mol%; and(d) mannitol in an amount of about 77.99 mol% to about 93.16 mol%.

[0476] In some embodiments, the pharmaceutical composition comprises:(a) apraglutide in an amount of about 0.4 mol% to about 1.4 mol%;(b) glycine in an amount of about 3.39 mol% to about 10.16 mol%;(c) L-histidine in an amount of about 5.77 mol% to about 7.77 mol%; and(d) mannitol in an amount of about 77.99 mol% to about 93.16 mol%.

[0477] In some embodiments, the pharmaceutical composition comprises:(a) apraglutide in an amount of about 0.4 mol% to about 1.4 mol%;(b) glycine in an amount of about 3.39 mol% to about 10.16 mol%;(c) L-histidine in an amount of about 6.47 mol% to about 7.07 mol%; and(d) mannitol in an amount of about 77.99 mol% to about 93.16 mol%.

[0478] In some embodiments, the pharmaceutical composition comprises:(a) apraglutide in an amount of about 0.4 mol% to about 1.4 mol%;(b) glycine in an amount of about 3.39 mol% to about 10.16 mol%;(c) L-histidine in an amount of about 6.77 mol%; and(d) mannitol in an amount of about 77.99 mol% to about 93.16 mol%.

[0479] In some embodiments, the pharmaceutical composition comprises:(a) apraglutide in an amount of about 0.5 mol% to about 1.3 mol%;(b) glycine in an amount of about 3.39 mol% to about 10.16 mol%;(c) L-histidine in an amount of about 4.77 mol% to about 8.77 mol%; and(d) mannitol in an amount of about 77.99 mol% to about 93.16 mol%.

[0480] In some embodiments, the pharmaceutical composition comprises:(a) apraglutide in an amount of about 0.5 mol% to about 1.3 mol%;(b) glycine in an amount of about 3.39 mol% to about 10.16 mol%;(c) L-histidine in an amount of about 5.77 mol% to about 7.77 mol%; and(d) mannitol in an amount of about 77.99 mol% to about 93.16 mol%.

[0481] In some embodiments, the pharmaceutical composition comprises:VECT-007 / 001WO (43765-02067)(a) apraglutide in an amount of about 0.5 mol% to about 1.3 mol%;(b) glycine in an amount of about 3.39 mol% to about 10.16 mol%;(c) L-histidine in an amount of about 6.47 mol% to about 7.07 mol%; and(d) mannitol in an amount of about 77.99 mol% to about 93.16 mol%.

[0482] In some embodiments, the pharmaceutical composition comprises:(a) apraglutide in an amount of about 0.5 mol% to about 1.3 mol%;(b) glycine in an amount of about 3.39 mol% to about 10.16 mol%;(c) L-histidine in an amount of about 6.77 mol%; and(d) mannitol in an amount of about 77.99 mol% to about 93.16 mol%.

[0483] In some embodiments, the pharmaceutical composition comprises:(a) apraglutide in an amount of about 0.7 mol% to about 1.1 mol%;(b) glycine in an amount of about 3.39 mol% to about 10.16 mol%;(c) L-histidine in an amount of about 4.77 mol% to about 8.77 mol%; and(d) mannitol in an amount of about 77.99 mol% to about 93.16 mol%.

[0484] In some embodiments, the pharmaceutical composition comprises:(a) apraglutide in an amount of about 0.7 mol% to about 1.1 mol%;(b) glycine in an amount of about 3.39 mol% to about 10.16 mol%;(c) L-histidine in an amount of about 5.77 mol% to about 7.77 mol%; and(d) mannitol in an amount of about 77.99 mol% to about 93.16 mol%.

[0485] In some embodiments, the pharmaceutical composition comprises:(a) apraglutide in an amount of about 0.7 mol% to about 1.1 mol%;(b) glycine in an amount of about 3.39 mol% to about 10.16 mol%;(c) L-histidine in an amount of about 6.47 mol% to about 7.07 mol%; and(d) mannitol in an amount of about 77.99 mol% to about 93.16 mol%.

[0486] In some embodiments, the pharmaceutical composition comprises:(a) apraglutide in an amount of about 0.7 mol% to about 1.1 mol%;(b) glycine in an amount of about 3.39 mol% to about 10.16 mol%;(c) L-histidine in an amount of about 6.77 mol%; and(d) mannitol in an amount of about 77.99 mol% to about 93.16 mol%.

[0487] In some embodiments, the pharmaceutical composition comprises:(a) apraglutide in an amount of about 0.8 mol% to about 1.0 mol%;(b) glycine in an amount of about 3.39 mol% to about 10.16 mol%;(c) L-histidine in an amount of about 4.77 mol% to about 8.77 mol%; and(d) mannitol in an amount of about 77.99 mol% to about 93.16 mol%.VECT-007 / 001WO (43765-02067)

[0488] In some embodiments, the pharmaceutical composition comprises:(a) apraglutide in an amount of about 0.8 mol% to about 1.0 mol%;(b) glycine in an amount of about 3.39 mol% to about 10.16 mol%;(c) L-histidine in an amount of about 5.77 mol% to about 7.77 mol%; and(d) mannitol in an amount of about 77.99 mol% to about 93.16 mol%.

[0489] In some embodiments, the pharmaceutical composition comprises:(a) apraglutide in an amount of about 0.8 mol% to about 1.0 mol%;(b) glycine in an amount of about 3.39 mol% to about 10.16 mol%;(c) L-histidine in an amount of about 6.47 mol% to about 7.07 mol%; and(d) mannitol in an amount of about 77.99 mol% to about 93.16 mol%.

[0490] In some embodiments, the pharmaceutical composition comprises:(a) apraglutide in an amount of about 0.8 mol% to about 1.0 mol%;(b) glycine in an amount of about 3.39 mol% to about 10.16 mol%;(c) L-histidine in an amount of about 6.77 mol%; and(d) mannitol in an amount of about 77.99 mol% to about 93.16 mol%.

[0491] In some embodiments, the pharmaceutical composition comprises:(a) apraglutide in an amount of about 0.9 mol%;(b) glycine in an amount of about 3.39 mol% to about 10.16 mol%;(c) L-histidine in an amount of about 4.77 mol% to about 8.77 mol%; and(d) mannitol in an amount of about 77.99 mol% to about 93.16 mol%.

[0492] In some embodiments, the pharmaceutical composition comprises:(a) apraglutide in an amount of about 0.9 mol%;(b) glycine in an amount of about 3.39 mol% to about 10.16 mol%;(c) L-histidine in an amount of about 5.77 mol% to about 7.77 mol%; and(d) mannitol in an amount of about 77.99 mol% to about 93.16 mol%.

[0493] In some embodiments, the pharmaceutical composition comprises:(a) apraglutide in an amount of about 0.9 mol%;(b) glycine in an amount of about 3.39 mol% to about 10.16 mol%;(c) L-histidine in an amount of about 6.47 mol% to about 7.07 mol%; and(d) mannitol in an amount of about 77.99 mol% to about 93.16 mol%.

[0494] In some embodiments, the pharmaceutical composition comprises:(a) apraglutide in an amount of about 0.9 mol%;(b) glycine in an amount of about 3.39 mol% to about 10.16 mol%;(c) L-histidine in an amount of about 6.77 mol%; andVECT-007 / 001WO (43765-02067)(d) mannitol in an amount of about 77.99 mol% to about 93.16 mol%.

[0495] In some embodiments, the pharmaceutical composition comprises:(a) apraglutide in an amount of about 0.4 mol% to about 1.4 mol%;(b) glycine in an amount of about 3.39 mol% to about 10.16 mol%;(c) L-histidine in an amount of about 3.39 mol% to about 10.16 mol%; and(d) mannitol in an amount of about 81.57 mol% to about 89.57 mol%.

[0496] In some embodiments, the pharmaceutical composition comprises:(a) apraglutide in an amount of about 0.4 mol% to about 1.4 mol%;(b) glycine in an amount of about 3.39 mol% to about 10.16 mol%;(c) L-histidine in an amount of about 3.39 mol% to about 10.16 mol%; and(d) mannitol in an amount of about 83.57 mol% to about 87.57 mol%.

[0497] In some embodiments, the pharmaceutical composition comprises:(a) apraglutide in an amount of about 0.4 mol% to about 1.4 mol%;(b) glycine in an amount of about 3.39 mol% to about 10.16 mol%;(c) L-histidine in an amount of about 3.39 mol% to about 10.16 mol%; and(d) mannitol in an amount of about 84.90 mol% to about 86.27 mol%.

[0498] In some embodiments, the pharmaceutical composition comprises:(a) apraglutide in an amount of about 0.4 mol% to about 1.4 mol%;(b) glycine in an amount of about 3.39 mol% to about 10.16 mol%;(c) L-histidine in an amount of about 3.39 mol% to about 10.16 mol%; and(d) mannitol in an amount of about 85.57 mol%.

[0499] In some embodiments, the pharmaceutical composition comprises:(a) apraglutide in an amount of about 0.5 mol% to about 1.3 mol%;(b) glycine in an amount of about 3.39 mol% to about 10.16 mol%;(c) L-histidine in an amount of about 3.39 mol% to about 10.16 mol%; and(d) mannitol in an amount of about 81.57 mol% to about 89.57 mol%.

[0500] In some embodiments, the pharmaceutical composition comprises:(a) apraglutide in an amount of about 0.5 mol% to about 1.3 mol%;(b) glycine in an amount of about 3.39 mol% to about 10.16 mol%;(c) L-histidine in an amount of about 3.39 mol% to about 10.16 mol%; and(d) mannitol in an amount of about 83.57 mol% to about 87.57 mol%.

[0501] In some embodiments, the pharmaceutical composition comprises:(a) apraglutide in an amount of about 0.5 mol% to about 1.3 mol%;(b) glycine in an amount of about 3.39 mol% to about 10.16 mol%;VECT-007 / 001WO (43765-02067)(c) L-histidine in an amount of about 3.39 mol% to about 10.16 mol%; and(d) mannitol in an amount of about 84.90 mol% to about 86.27 mol%.

[0502] In some embodiments, the pharmaceutical composition comprises:(a) apraglutide in an amount of about 0.5 mol% to about 1.3 mol%;(b) glycine in an amount of about 3.39 mol% to about 10.16 mol%;(c) L-histidine in an amount of about 3.39 mol% to about 10.16 mol%; and(d) mannitol in an amount of about 85.57 mol%.

[0503] In some embodiments, the pharmaceutical composition comprises:(a) apraglutide in an amount of about 0.7 mol% to about 1.1 mol%;(b) glycine in an amount of about 3.39 mol% to about 10.16 mol%;(c) L-histidine in an amount of about 3.39 mol% to about 10.16 mol%; and(d) mannitol in an amount of about 81.57 mol% to about 89.57 mol%.

[0504] In some embodiments, the pharmaceutical composition comprises:(a) apraglutide in an amount of about 0.7 mol% to about 1.1 mol%;(b) glycine in an amount of about 3.39 mol% to about 10.16 mol%;(c) L-histidine in an amount of about 3.39 mol% to about 10.16 mol%; and(d) mannitol in an amount of about 83.57 mol% to about 87.57 mol%.

[0505] In some embodiments, the pharmaceutical composition comprises:(a) apraglutide in an amount of about 0.7 mol% to about 1.1 mol%;(b) glycine in an amount of about 3.39 mol% to about 10.16 mol%;(c) L-histidine in an amount of about 3.39 mol% to about 10.16 mol%; and(d) mannitol in an amount of about 84.90 mol% to about 86.27 mol%.

[0506] In some embodiments, the pharmaceutical composition comprises:(a) apraglutide in an amount of about 0.7 mol% to about 1.1 mol%;(b) glycine in an amount of about 3.39 mol% to about 10.16 mol%;(c) L-histidine in an amount of about 3.39 mol% to about 10.16 mol%; and(d) mannitol in an amount of about 85.57 mol%.

[0507] In some embodiments, the pharmaceutical composition comprises:(a) apraglutide in an amount of about 0.8 mol% to about 1.0 mol%;(b) glycine in an amount of about 3.39 mol% to about 10.16 mol%;(c) L-histidine in an amount of about 3.39 mol% to about 10.16 mol%; and(d) mannitol in an amount of about 81.57 mol% to about 89.57 mol%.

[0508] In some embodiments, the pharmaceutical composition comprises:(a) apraglutide in an amount of about 0.8 mol% to about 1.0 mol%;VECT-007 / 001WO (43765-02067)(b) glycine in an amount of about 3.39 mol% to about 10.16 mol%;(c) L-histidine in an amount of about 3.39 mol% to about 10.16 mol%; and(d) mannitol in an amount of about 83.57 mol% to about 87.57 mol%.

[0509] In some embodiments, the pharmaceutical composition comprises:(a) apraglutide in an amount of about 0.8 mol% to about 1.0 mol%;(b) glycine in an amount of about 3.39 mol% to about 10.16 mol%;(c) L-histidine in an amount of about 3.39 mol% to about 10.16 mol%; and(d) mannitol in an amount of about 84.90 mol% to about 86.27 mol%.

[0510] In some embodiments, the pharmaceutical composition comprises:(a) apraglutide in an amount of about 0.8 mol% to about 1.0 mol%;(b) glycine in an amount of about 3.39 mol% to about 10.16 mol%;(c) L-histidine in an amount of about 3.39 mol% to about 10.16 mol%; and(d) mannitol in an amount of about 85.57 mol%.

[0511] In some embodiments, the pharmaceutical composition comprises:(a) apraglutide in an amount of about 0.9 mol%;(b) glycine in an amount of about 3.39 mol% to about 10.16 mol%;(c) L-histidine in an amount of about 3.39 mol% to about 10.16 mol%; and(d) mannitol in an amount of about 81.57 mol% to about 89.57 mol%.

[0512] In some embodiments, the pharmaceutical composition comprises:(a) apraglutide in an amount of about 0.9 mol%;(b) glycine in an amount of about 3.39 mol% to about 10.16 mol%;(c) L-histidine in an amount of about 3.39 mol% to about 10.16 mol%; and(d) mannitol in an amount of about 83.57 mol% to about 87.57 mol%.

[0513] In some embodiments, the pharmaceutical composition comprises:(a) apraglutide in an amount of about 0.9 mol%;(b) glycine in an amount of about 3.39 mol% to about 10.16 mol%;(c) L-histidine in an amount of about 3.39 mol% to about 10.16 mol%; and(d) mannitol in an amount of about 84.90 mol% to about 86.27 mol%.

[0514] In some embodiments, the pharmaceutical composition comprises:(a) apraglutide in an amount of about 0.9 mol%;(b) glycine in an amount of about 3.39 mol% to about 10.16 mol%;(c) L-histidine in an amount of about 3.39 mol% to about 10.16 mol%; and(d) mannitol in an amount of about 85.57 mol%.VECT-007 / 001WO (43765-02067)Pharmaceutical Composition Numbered “A ” Embodiments

[0515] Embodiment Al. A pharmaceutical composition comprising: (a) apraglutide in an amount of about 15.5 % to about 17.5 % by weight of total solids; (b) glycine in an amount of about 1.25 % to about 3.75 % by weight of total solids; (c) L-histidine in an amount of about 2.55 % to about 7.65 % by weight of total solids; and (d) mannitol in an amount of about 63,15 % to about 88,65 % by weight of total solids,

[0516] Embodiment A2. The pharmaceutical composition according to Embodiment Al. wherein glycine is present in an amount of about 1.98 % to about 2.98 % by weight of total solids.

[0517] Embodiment A3. The pharmaceutical composition according to any one of Embodiments Al or A2, wherein glycine is present in an amount of about 2.28 % to about 2.68 % by weight of total solids.

[0518] Embodiment A4. The pharmaceutical composition according to any one of Embodiments A1-A3, wherein glycine is present in an amount of about 2.48 % by weight of total solids.

[0519] Embodiment A5. The pharmaceutical composition according to Embodiment Al, wherein mannitol is present in an amount of about 69, 15 % to about 82,65 % by weight of total solids.

[0520] Embodiment A6. The pharmaceutical composition according to any one of Embodiments A1 or A5, wherein mannitol is present in an amount of about 72.92 % to about 78.92 % by weight of total solids.

[0521] Embodiment A7. The pharmaceutical composition according to any one of Embodiments Al, A5 or A6, wherein mannitol is present in an amount of about 74.92 % to about 76.92 % by weight of total solids,

[0522] Embodiment A8. The pharmaceutical composition according to any one of Embodiments A1--A7, wherein mannitol is present in an amount of about 75.92 % by weight of total solids,

[0523] Embodiment A9. The pharmaceutical composition according to Embodiment Al, wherein L-histidine is present in an amount of about 3.50 % to about 6.70 % by weight of total solids.

[0524] Embodiment A 10. The pharmaceutical composition according to any one of Embodiments Al or A9, wherein L-histidine is present in an amount of about 4.35 % to about 5.85 % by weight of total solids.

[0525] Embodiment A11. The pharmaceutical composition according to any one ofVECT-007 / 001WO (43765-02067)Embodiments Al, A9 or A10, wherein L-histidine is present in an amount of about 4.90 % to about 5.30 % by weight of total solids.

[0526] Embodiment A12. The pharmaceutical composition according to any one of Embodiments Al - Al 1, wherein L-histidine is present in an amount of about 5.10 % by weight of total solids.

[0527] Embodiment A13. The pharmaceutical composition according to Embodiment Al, wherein apraglutide is present in an amount of about 16.5 % by weight of total solids.

[0528] Embodiment A14. The pharmaceutical composition according to any one of Embodiments A1-A13, wherein apraglutide is present in an amount of about 15.5 % to about 17.5 % by weight in combination with glycine at about 2.48 %, L-histidine at about 5.10 %, and mannitol at about 75.92 % by weight of total solids.

[0529] Embodiment A15. The pharmaceutical composition according to any one of Embodiments A1-A13, wherein apraglutide is present in an amount of about 15.5 %to about 17.5 % by weight in combination with glycine at about 2.48 %, L-histidine at about 4.90 % to about 5.30 %, and mannitol at about 74.92 % to about 76.92 % by weight of total solids.

[0530] Embodiment A 16. The pharmaceutical composition according to any one of Embodiments A 1-Al 5, wherein the composition is in lyophilized form.

[0531] Embodiment A 17. The pharmaceutical composition according to any one of Embodiments A 1-Al 6, wherein glycine serves as a buffering agent, L-histidine serves as a stabilizing agent, and mannitol serves as a bulking agent,

[0532] Embodiment Al 8. The pharmaceutical composition according to any one of Embodiments A1-A17, wherein apraglutide is present as the sodium salt.

[0533] Embodiment A 19. The pharmaceutical composition according to any one of Embodiments A1-A18, wherein mannitol is crystalline.

[0534] Embodiment A20. The pharmaceutical composition according to any one of Embodiments Al -A19, wherein the components are combined in aqueous solution prior to lyophilization.

[0535] Embodiment A21. A pharmaceutical composition comprising: (a) apraglutide in an amount of about 15.5 % to about 17.5 % by weight of total solids; (b) a buffering agent in an amount of about 1.25 % to about 3.75 % by weight of total solids; (c) a stabilizing agent in an amount of about 2,55 % to about 7.65 % by weight of total solids; (d) a bulking agent in an amount of about 63.15 % to about 88.65 % by weight of total solids.

[0536] Embodiment A22. The pharmaceutical composition according to Embodiment A21, wherein the buffering agent comprises glycine.VECT-007 / 001WO (43765-02067)

[0537] Embodiment A23. The pharmaceutical composition according to any one of Embodiments A21 or K 1, wherein the stabilizing agent comprises L-histidine.

[0538] Embodiment A24. The pharmaceutical composition according to any one of Embodiments A21–A23, wherein the bulking agent comprises mannitol.

[0539] Embodiment A25. The pharmaceutical composition according to any one of Embodiments A21–A24, wherein the buffering agent is present in an amount of about 1.98 % to about 2.98 % by weight of total solids.

[0540] Embodiment A26. The pharmaceutical composition according to any one of Embodiments A21–A25, wherein the buffering agent is present in an amount of about 2.28 % to about 2.68 % by weight of total solids.

[0541] Embodiment A27. The pharmaceutical composition according to any one of Embodiments A21–A26, wherein the buffering agent is present in an amount of about 2.48 % by weight of total solids.

[0542] Embodiment A28. The pharmaceutical composition according to any one of Embodiments A21–A27, wherein the stabilizing agent is present in an amount of about 3.50 % to about 6.70 % by weight of total solids.

[0543] Embodiment A29. The pharmaceutical composition according to any one of Embodiments A21–A28, wherein the stabilizing agent is present in an amount of about 4.35 % to about 5.85 % by weight of total solids.

[0544] Embodiment A30. The pharmaceutical composition according to any one of Embodiments A21–A29, wherein the stabilizing agent is present in an amount of about 4.90 % to about 5.30 % by weight of total solids.

[0545] Embodiment A31. The pharmaceutical composition according to any one of Embodiments A21–A30, wherein the stabilizing agent is present in an amount of about 5.10 % by weight of total solids.

[0546] Embodiment A32. The pharmaceutical composition according to any one of Embodiments A21–A31, wherein the bulking agent is present in an amount of about 69.15 % to about 82.65 % by weight of total solids.

[0547] Embodiment A33. The pharmaceutical composition according to any one of Embodiments A21–A32, wherein the bulking agent is present in an amount of about 72.92 % to about 78.9 % by weight of total solids.

[0548] Embodiment A34. The pharmaceutical composition according to any one of Embodiments A21–A33, wherein the bulking agent is present in an amount of about 74.92 % to about 76.92 % by weight of total solids.VECT-007 / 001WO (43765-02067)

[0549] Embodiment A35. The pharmaceutical composition according to any one of Embodiments A21–A34, wherein the bulking agent is present in an amount of about 75.92% by weight of total solids.

[0550] Embodiment A36. The pharmaceutical composition according to any one of Embodiments A21–A35, wherein apraglutide is present as a sodium salt.

[0551] Embodiment A37. The pharmaceutical composition according to any one of Embodiments A21–A36, wherein the composition is lyophilized.

[0552] Embodiment A38. The pharmaceutical composition according to any one of Embodiments A21–A37, wherein the bulking agent is crystalline mannitol.

[0553] Embodiment A39. The pharmaceutical composition according to any one of Embodiments A21–A38, wherein the components are dissolved in aqueous solution prior to lyophilization.

[0554] Embodiment A40. The pharmaceutical composition according to any one of Embodiments A21–A39, wherein the buffering agent and stabilizing agent are present in molar ratios between about 1:1 and about 1:2.

[0555] Embodiment A41. A pharmaceutical composition comprising: (a) apraglutide in an amount of about 0.4 mol % to about 1.4 mol %; (b) a buffering agent in an amount of about 3.38 mol % to about 10.14 mol %; (c) a stabilizing agent in an amount of about 3.38 mol % to about 10.14 mol %; (d) a bulking agent in an amount of about 77.97 mol % to about 93.17 mol %.

[0556] Embodiment A42. The pharmaceutical composition according to Embodiment A41, wherein the buffering agent comprises glycine.

[0557] Embodiment A43. The pharmaceutical composition according to any one of Embodiments A41 or A42, wherein the stabilizing agent comprises L-histidine.

[0558] Embodiment A44. The pharmaceutical composition according to any one of Embodiments A41–A43, wherein the bulking agent comprises mannitol.

[0559] Embodiment A45. The pharmaceutical composition according to any one of Embodiments A41–A44, wherein apraglutide is present in an amount of about 0.5 mol % to about 1.3 mol %.

[0560] Embodiment A46. The pharmaceutical composition according to any one of Embodiments A41–A45, wherein apraglutide is present in an amount of about 0.7 mol % to about 1.1 mol %.

[0561] Embodiment A47. The pharmaceutical composition according to any one of Embodiments A41–A46, wherein apraglutide is present in an amount of about 0.8 mol % toVECT-007 / 001WO (43765-02067)about 1.0 mol %.

[0562] Embodiment A48. The pharmaceutical composition according to any one of Embodiments A41–A47, wherein apraglutide is present in an amount of about 0.9 mol °A>.

[0563] Embodiment A49. The pharmaceutical composition according to any one of Embodiments A41-A44, wherein the buffering agent is present in an amount of about 4.77 mol % to about 8.77 mol %;4.77 mol % to about 8,77 mol %.

[0564] Embodiment A50. The pharmaceutical composition according to any one of Embodiments A41-A49, wherein the buffering agent is present in an amount of about 5.77 mol % to about 7.77 mol %;5.77 mol % to about 7.77 mol %.

[0565] Embodiment A51. The pharmaceutical composition according to any one of Embodiments A41–A50, wherein the buffering agent is present in an amount of about 6.47 mol % to about 7.07 mol %.

[0566] Embodiment A52. Tire pharmaceutical composition according to any one of Embodiments A41-A51, wherein the buffering agent is present in an amount of about 6.77 mol %.

[0567] Embodiment A53. The pharmaceutical composition according to any one of Embodiments A41–A44, wherein the stabilizing agent is present in an amount of about 4.77 mol % to about 8.77 mol %;4.77 mol % to about 8.77 mol %.

[0568] Embodiment A54. The pharmaceutical composition according to any one of Embodiments A41–A53, wherein the stabilizing agent is present in an amount of about 5.77 mol % to about 7.77 mol %;5.77 mol % to about 7.77 mol %.

[0569] Embodiment A55. The pharmaceutical composition according to any one of Embodiments A41-A54, wherein the stabilizing agent is present in an amount of about 6.47 mol % to about 7.07 mol %.

[0570] Embodiment A56. The pharmaceutical composition according to any one of Embodiments A41–A55, wherein the stabilizing agent is present in an amount of about 6.77 mol %.

[0571] Embodiment A57. The pharmaceutical composition according to any one of Embodiments A41–A44, wherein the bulking agent is present in an amount of about 81.57 mol % to about 89.57 mol %.

[0572] Embodiment A58. The pharmaceutical composition according to any one of Embodiments A41–A57, wherein the bulking agent is present in an amount of about 83.57 mol % to about 87.57 mol %.

[0573] Embodiment A59. The pharmaceutical composition according to any one of Embodiments A41–A58, wherein the bulking agent is present in an amount of about 84.87 mol % to about 86.27 mol %.

[0574] Embodiment A60. The pharmaceutical composition according to any one of Embodiments A41–A59, wherein the bulking agent is present in an amount of about 85.57 mol %.

[0575] Embodiment A61. A pharmaceutical composition comprising: (a) apraglutide in an amount of about 0.4 mol % to about 1.4 mol %; (b) glycine in an amount of about 3.38 mol % to about 10.14 mol %; (c) L-histidine in an amount of about 3.38 mol % to about 10.14 mol %; (d) mannitol in an amount of about 77.97 mol % to about 93.17 mol %.

[0576] Embodiment A62. The pharmaceutical composition according to Embodiment A61, wherein apraglutide is present in an amount of about 0.5 mol % to about 1.3 mol %.

[0577] Embodiment A63. The pharmaceutical composition according to any one of Embodiments A61 or A62, wherein apraglutide is present in an amount of about 0.7 mol % to about 1.1 mol %.

[0578] Embodiment A64. The pharmaceutical composition according to any one of Embodiments A61–A63, wherein apraglutide is present in an amount of about 0.8 mol % to about 1.0 mol %.

[0579] Embodiment A65. The pharmaceutical composition according to any one of Embodiments A61–A64, wherein apraglutide is present in an amount of about 0.9 mol %.

[0580] Embodiment A66. The pharmaceutical composition according to Embodiment A61, wherein glycine is present in an amount of about 4.77 mol % to about 8.77 mol %; 4.77 mol % to about 8.77 mol %.

[0581] Embodiment A67. The pharmaceutical composition according to any one of Embodiments A61 or A66, wherein glycine is present in an amount of about 5.77 mol % to about 7.77 mol %; 5.77 mol % to about 7.77 mol %.

[0582] Embodiment A68. The pharmaceutical composition according to any one of Embodiments A61, A66 or A67, wherein glycine is present in an amount of about 6.47 mol % to about 7.07 mol %.

[0583] Embodiment A69. The pharmaceutical composition according to any one of Embodiments A61–A68, wherein glycine is present in an amount of about 6.77 mol %.

[0584] Embodiment A70. The pharmaceutical composition according to Embodiment A61, wherein L-histidine is present in an amount of about 4.77 mol % to about 8.77 mol4.77 mol % to about 8.77 mol %.VECT-007 / 001WO (43765-02067)

[0585] Embodiment A71. The pharmaceutical composition according to any one of Embodiments A61 or A70, wherein L-histidine is present in an amount of about 5.77 mol %to about 7.77 mol %; 5.77 mol % to about 7.77 mol ° >.

[0586] Embodiment A72. The pharmaceutical composition according to any one of Embodiments A61, A70 or A71, wherein L-histidine is present in an amount of about 6.47 mol % to about 7.07 mol %.

[0587] Embodiment A73. The pharmaceutical composition according to any one of Embodiments A61–A72, wherein L-histidine is present in an amount of about 6.77 mol %.

[0588] Embodiment A74. The pharmaceutical composition according to Embodiment A61, wherein mannitol is present in an amount of about 81.57 mol % to about 89.57 mol %.

[0589] Embodiment A75. The pharmaceutical composition according to any one of Embodiments A61 or A74, wherein mannitol is present in an amount of about 83.57 mol % to about 87.57 mol %.

[0590] Embodiment A76. The pharmaceutical composition according to any one of Embodiments A61, A74 or A75, wherein mannitol is present in an amount of about 84.87 mol % to about 86.27 mol %.

[0591] Embodiment A77. The pharmaceutical composition according to any one of Embodiments A61–A76, wherein mannitol is present in an amount of about 85.57 mol %.

[0592] Embodiment A78. The pharmaceutical composition according to any one of Embodiments A61–A77, wherein apraglutide is present as a sodium salt,

[0593] Embodiment A79. The pharmaceutical composition according to any one of Embodiments A61–A78, wherein the composition is lyophilized.

[0594] Embodiment A80. The pharmaceutical composition according to any one of Embodiments A61–A79, wherein the components are dissolved in aqueous solution prior to lyophilization.

[0595] Embodiment A81. A pharmaceutical composition comprising: (a) apraglutide in an amount of about 15.5 % to about 17.5 % by weight of total solids; (b) a buffering agent in an amount of about 4.77 mol % to about 8.77 mol %;; (c) a stabilizing agent in an amount of about 5.77 mol % to about 7.77 mol %;; (d) mannitol in an amount of about 72.92 % to about 78.92 % by weight of total solids.

[0596] Embodiment A82. The pharmaceutical composition according to Embodiment A81, wherein the buffering agent comprises glycine.

[0597] Embodiment A83. The pharmaceutical composition according to any one of Embodiments A81 or A82, wherein the buffering agent is present in an amount of aboutVECT-007 / 001WO (43765-02067)5.77 mol % to about 7.77 mol %;5.77 mol % to about 7.77 mol %.

[0598] Embodiment A84. The pharmaceutical composition according to any one of Embodiments A81–A83, wherein the buffering agent is present in an amount of about 6.47 mol % to about 7.07 mol %.

[0599] Embodiment A85. The pharmaceutical composition according to any one of Embodiments A81–A84, wherein the buffering agent is present in an amount of about 6.77 mol %.

[0600] Embodiment A86. The pharmaceutical composition according to any one of Embodiments A81-A85, wherein the stabilizing agent comprises L-histidine.

[0601] Embodiment A87. The pharmaceutical composition according to any one of Embodiments A81–A86, wherein the stabilizing agent is present in an amount of about 4.77 mol % to about 8.77 mol %; 4.77 mol % to about 8.77 mol %.

[0602] Embodiment A88. The pharmaceutical composition according to any one of Embodiments A81–A87, wherein the stabilizing agent is present in an amount of about 6.47 mol % to about 7.07 mol %.

[0603] Embodiment A89. The pharmaceutical composition according to any one of Embodiments A81–A88, wherein the stabilizing agent is present in an amount of about 6.77 mol %.

[0604] Embodiment A90. The pharmaceutical composition according to any one of Embodiments A81–A89, wherein apraglutide is present in an amount of about 16.5 % by weight of total solids.

[0605] Embodiment A91. The pharmaceutical composition according to any one of Embodiments A81–A90, wherein mannitol is present in an amount of about 74.92 % to about 76.92 % by weight of total solids.

[0606] Embodiment A92. The pharmaceutical composition according to any one of Embodiments A81–A91, wherein mannitol is crystalline.

[0607] Embodiment A93. The pharmaceutical composition according to any one of Embodiments A81–A92, wherein apraglutide is present as a sodium salt.

[0608] Embodiment A94. The pharmaceutical composition according to any one of Embodiments A81–A93, wherein the composition is lyophilized.

[0609] Embodiment A95. The pharmaceutical composition according to any one of Embodiments A81–A94, wherein the components are combined in aqueous solution prior to lyophilization.

[0610] Embodiment A96. A pharmaceutical composition comprising:VECT-007 / 001WO (43765-02067)(a) apraglutide in an amount of about 0.8 mol % to about 1.0 mol %; (b) glycine in an amount of about 2.48 % by weight of total solids; (c) a stabilizing agent in an amount of about 4.90 mol % to about 5.30 mol %; (d) mannitol in an amount of about 75.92 % by weight of total solids.

[0611] Embodiment A97. The pharmaceutical composition according to Embodiment A96, wherein the stabilizing agent comprises L-histidine.

[0612] Embodiment A98. The pharmaceutical composition according to any one of Embodiments A96 or A97, wherein the stabilizing agent is present in an amount of about 6.47 mol % to about 7.07 mol %.

[0613] Embodiment A99. The pharmaceutical composition according to any one of Embodiments A96–A98, wherein the stabilizing agent is present in an amount of about 6.77 mol %.

[0614] Embodiment A100. The pharmaceutical composition according to any one of Embodiments A96–A99, wherein mannitol is crystalline.

[0615] Embodiment A101. The pharmaceutical composition according to any one of Embodiments A96–A100, wherein apraglutide is present as a sodium salt.

[0616] Embodiment A102. The pharmaceutical composition according to any one of Embodiments A96–A101, wherein the composition is lyophilized.

[0617] Embodiment A103. The pharmaceutical composition according to any one of Embodiments A96–A102, wherein the components are dissolved in aqueous solution prior to lyophilization.

[0618] Exemplary pharmaceutical compositions of the present disclosure are provided in Tables 1A-G,Table 1A-1. Exemplary pharmaceutical compositions comprising apraglutide5.2 mg / vial Pre-lyophilization Function Solution (mg / mL) ComponentQuantity ReconstitutedQuantity Quantity(mole Solution(mg / vial) (wt %) ’%) (nig / mL)3Apraglutide Drug 5.2b16.5% 0.9% 21.0 10.0 (Free acid) substanceBuffering 1.50 Glycine 0.78 2.48% 6.77% 3.1agentStabilizing 3.10 L-Histidine 1.61 5.11% 6.76% 6.4agentBulking 46.0 Mannitol 23.92 75.91% 85.57% 95.0agentVECT-007 / 001WO (43765-02067)5,2 mg / vial Pre-lyophilization Function Solution (mg / mL) ComponentQuantity ReconstitutedQuantity Quantity’(mole Solution(mg / vial) (wt %)%) (mg / mL)aSodium pH q.s. to — — — q.s. to pH 8.3 Hydroxide adjustment pH 8.3Water for q.s. to 1.0 mL injection q.s. toSolvent ““ ““0.52 mL(WFI)°ProcessingNitrogend— — — ““aidEffectiveSterile water added — 0.23 mLfor injection Reconstitution VolumeaReconstituted concentration based on a displacement volume of 0,69 mL / g of lyophilized cake and the mass of lyophilized cake. Cake weight for 5.2 mg is 0.03151g, and cake weight for 10.4 mg is 0.06302 g.bThe quantity of drug substance to be used is calculated based on the apraglutide content in the corresponding drug substance batch.0Component used during the manufacture that does not appear in the final product,dUsed as inert overlay in the finished product.Table 1A-2 Exemplary pharmaceutical compositions comprising apraglutide10.4 mg / vial Pre-lyophilization Solution (mg / mL) Component FunctionReconstitutedQuantity Quantity Quantity Solution(mg / vial) (wt %) (mole %) (mg / mL)aApraglutide Drug 10.4b10.016.5% 0.9% 21.0(Free acid) substanceBuffering 1.50 Glycine 1.56 2.48% 6.77% 3.2agentStabilizing 3.10 L-Histidine 3.22 5.11% 6.76% 6.5agentBulking 46.0 Mannitol 47.84 75.91% 85.57% 97.0agentpHSodium q.s. to pH 8.3 adjustmen q.s. to pH ““ ““ ““Hydroxide 8.3tWater for q.s. to 1.0 mL injection q.s. toSolvent ““ ““(WFI)C1.04 mLProcessingNitrogend— — —aidEffectiveaddedSterile water — — 0,45 mLfor injection ReconstitutionVolumeVECT-007 / 001WO (43765-02067)aReconstituted concentration based on a displacement volume of 0.69 mL / g of lyophilized cake and the mass of lyophilized cake. Cake weight for 5.2 mg is 0.03151g, and cake weight for 10.4 mg is 0.06302 g,bThe quantity of drag substance to be used is calculated based on the apraglutide content in the corresponding drug substance batch.cComponent used during the manufacture that does not appear in the final product.dUsed as inert overlay in the finished product.Table 1B. Exemplary pharmaceutical compositions comprising apraglutide5.4 mg / vialPre- Lyophilizati Component FunctionQua ReconstitutedQuantity Quantity ntity’ on Solution,Solution(mg / vial) (wt %) (mole %) mg / mL (mg / mL)aApraglutide(as free Active 5.4b16.5% 0.9% 8.8 10.0 acid)BufferingGlycine 0.81 2.48% 6.77% 1.3 1.5 AgentStabilizingL-Histidine 1.67 5.10% 6.76% 2.7 3.1 AgentMannitol Bulking Agent 24.84 75.92% 85.57% 40.6 46.0 Sodium q.s. to q.s. to pH pH Modifier — — - Hydroxide pH8.3 8.3 Water for q.s. to q.s. to 1.0 mL Solvent — -- - Injection 0.54 mL mL NitrogendProcessing Aid - — — - Sterile EffectiveWater for added ““ 0.59Injection, ReconstitutionmL VolumeaReconstituted concentration based on a displacement volume of 0.69 mL / g of lyophilized cake and the mass of lyophilized cake. Cake weight for 5.4 mg is 0.03272g.bThe quantity of drug substance to be used is calculated based on the apraglutide content in the corresponding drug substance batch.cComponent used during the manufacture that does not appear in the final product.dUsed as inert overlay in the finished product.Table 1C. Exemplary pharmaceutical compositions comprising apraglutide Component Function 5.4 mg / vial PreLyophilization Quantity Quantity Quantity Reconstituted Solution, (mg / vial) (wt %) (mole Solution mg / mL %) (mg / mL)aApraglutide Active 5.4b16.5% 0.9% 17.3 10.0(as free acid)VECT-007 / 001WO (43765-02067)Glycine Buffering 0.81 2.6 1.5Agent 2.48% 6.77%L-Histidine Stabilizing 1.67 5.3 3.1Agent 5.10% 6.76%Mannitol Bulking Agent 24.84 75.92% 85.57% 79.5 46.0 Sodium pH Modifier q.s. to - q.s. to pH 8.3 Hydroxide pH8.3Water for Solvent q.s. to - - - q.s, to 1.0 mL Injection00.54 mLNitrogendProcessing Aid - - Sterile Water Effective added 0.29for Injection, ReconstitutionmL VolumeaReconstituted concentration based on a displacement volume of 0.69 mL / g of lyophilized cake and the mass of lyophilized cake. Cake weight for 5,4 mg is 0.03272g.bThe quantity of drag substance to be used is calculated based on the apraglutide content in the corresponding drag substance batch.cComponent used during the manufacture that does not appear in the final product.dUsed as inert overlay in the finished productTable 1D. Exemplary pharmaceutical compositions comprising apraglutide Component Function 5.4 mg / vial Pre-Lyophilizatio Quantity Quantity Quantity Reconstitute n Solution, (mg / vial) (wt %) (mole d Solution mg / mL %) (mg / mL)aApraglutide Active 5.4b16.5% 0.9% 14.1 10.0(as free acid)Glycine Buffering 0.81 2.1 1.5Agent 2.48% 6.77%L-Histidine Stabilizing 1.67 4.4 3.1Agent 5.10% 6.76%Mannitol Bulking 24.84 64.9 46.075.92% 85.57%AgentSodium pH Modifier q.s. to pH - - - q.s. to pH 8.3 Hydroxide 8.3Water for Solvent q.s. to - - q.s. to 1.0 mL Injection00,54 mLNitrogendProcessing - - - AidSterile Effective 0.36Water for addedInjection, ReconstitutemL, n VolumeaReconstituted concentration based on a displacement volume of 0.69 mL / g of lyophilized cake and the mass of lyophilized cake. Cake weight for 10.4 mg is 0.06302 g.VECT-007 / 001WO (43765-02067)bThe quantity of drug substance to be used is calculated based on the apraglutide content in the corresponding drug substance batch.cComponent used during the manufacture that does not appear in the final product.dUsed as inert overlay in the finished productTable IE. Exemplary pharmaceutical compositions comprising apraglutide Component Function 10.4 mg / vial Pre- Lyophilization Quantity Quantity’ Quantity Reconstituted Solution, (mg / vial) (wt %) (mole %) Solution mg / mL (mg / mL)aApraglutide Active 10.4b16.5% 0.9% 17.5 10.0 (as free acid)Glycine Buffering 1.56 2.6 1.5Agent 2.48% 6.77%L-Histidine Stabilizing 3.22 5.4 3.1Agent 5.10% 6.76%Mannitol Bulking Agent 47.84 75.92% 85.57% 80.6 46.0 Sodium pH Modifier q.s. to pH - q.s. to pH 8.3 Hydroxide 8.3Water for Solvent q.s. to - - - q.s. to 1.0 mL Injectionc1.04 mLNitrogendProcessing Aid - - - - 0.55 Sterile Water Effective addedfor Injection, Reconstitutionml. VolumeaReconstituted concentration based on a displacement volume of 0.69 mL / g of lyophilized cake and the mass of lyophilized cake. Cake weight for 10.4 mg is 0.06302 g.bThe quantity of drug substance to be used is calculated based on the apraglutide content in the corresponding drag substance batch.cComponent used during the manufacture that does not appear in the final product.dUsed as inert overlay in the finished productTable IF. Exemplary pharmaceutical compositions comprising apraglutide10.4 mg / vialPreReconstituted Component Function Quantity Quantity Quantity Lyophilization Solution(mg / vial) (wt %) (mole %) Solution (mg / mL)a(mg / mL) Apraglutide Drug 10.4b16.5% 0.9% 20.6(Free acid) substanceBuffering1.56 2.48% 6.77% 3.1 1.5 Glycine AgentStabilizing3,22 5.10% 6.76% 6.4 3.1 L-HistidineAgentBulking47.84 75.92% 85.57% 95.0 46.0 MannitolAgentVECT-007 / 001WO (43765-02067)SodiumpH Modifier q.s. to - - - q.s. to pH 8.3 Hydroxide pH 8,3Water forSolvent q.s. to - - q.s. to 1.0 mL Injectionc1.04 mLProcessingNitrogen11- - - - - AidEffectiveSterileaddedWater for - 0.45 mL ReconstitutionInjectionVolumeaReconstitution concentration based on a displacement volume of 0.69 mL / g of lyophilized cake and the mass of lyophilized cake. Cake weight for 10.4 mg is 0.06302 g.bThe quantity of drug substance to be used is calculated based on the apraglutide content in the corresponding drug substance batch.cComponent used during the manufacture that does not appear in the final product.dUsed as inert overlay in the finished product.Table 1G. Exemplary pharmaceutical compositions comprising apraglutidePreLyophilization 10.4 mg / vial Solution (mg / mL) Component FunctionReconstitutedQuantity Quantity QuantitySolution(mg / vial) (wt %) (mole %) (nig / mL)aDrag Apraglutide10.4 16.5% 0.9% 20.3 10.0 (Free acid) substancebBuffering1.56 2.48% 6.77% 3.0 1.5 Glycine AgentStabilizing3.22 5.10% 6.76% 6.3 3.1 L-HistidineAgentBulking47.84 75.92% 85.57% 93.2 46.0 Mannitol AgentSodium q.s. to pH Modifier - - - q.s. to pH 8,3 pH 8,3 HydroxideWater for q.s. to Solvent - q.s. to 1.0 mL Injectionc1.04 mLProcessing- - - - - NitrogendAidEffectiveSterileadded Water for - - 0.45 mL ReconstitutionInjectionVolumeaReconstitution concentration based on a displacement volume of 0.69 mL / g of lyophilized cake and the mass of lyophilized cake. Cake weight for 10.4 mg is 0.06302 g.bThe quantity of drug substance to be used is calculated based on the apraglutide content in the corresponding drug substance batch.cComponent used during the manufacture that does not appear in the final product.VECT-007 / 001WO (43765-02067)dUsed as inert overlay in the finished product.

[0619] A pharmaceutical composition of the present disclosure may be provided as one of the embodiments provided in Tables A-V.Table A. Exemplary dose combinations of the present disclosure.Effective added Injection API Dose Apraglutide reconstitution volume [mg / vial] [mg] concentration volume [mL] [mL] [mg / mL] Embodiment A 0.59 0.40 5.4 3.5 8.80.59 0.25 5.4 2.2 8.8 Embodiment B 0.29 0.20 5.4 3.5 17.30.29 0.13 5.4 2.2 17.3 Embodiment C 0.36 0.25 5.4 3.5 14.10.36 0.15 5.4 2.1 14.1 Embodiment D 0.55 0.20 10.4 3.5 17.50.55 0.12 10.4 2.1 17.5Table B. Exemplary' dose combinationsEffective added Injection API Dose Apraglutide reconstitution volume volume [mL] [mg / vial] [mg] concentration [mL] [mg / mL] 0.36 0.25 5.4 3.5 14.10.36 0.16 5.4 2.3 14.10.36 0.15 5.4 2.1 14.10.44 0.30 5.4 3.5 11.70.44 0.20 5.4 2.3 11.70.44 0.19 5.4 2.2 11.70.44 0.18 5.4 2.1 11.70.51 0.35 5.4 3.5 10.10.51 0.20 5.4 2.0 10.10.59 0.40 5.4 3.5 8.80.59 0.25 5.4 2.2 8.8Table C. Exemplary dose combinationsEffective added Injection API Dose Apraglutide reconstitution volume [mg / vial] [mg] concentration [mg / mL] volume [mL] [mL]0.35 0.25 5.4 3.6 14.50.35 0.16 5.4 2.3 14.50.35 0.15 5.4 2.2 14.5VECT-007 / 001WO (43765-02067)0.43 0.30 5.4 3.6 11.90.43 0.19 5.4 2.3 11.90.43 0.18 5.4 2.1 11.90.50 0.35 5.4 3.6 10.30.50 0.20 5.4 2.1 10.30.57 0.40 5.4 3.6 9.10.57 0.25 5.4 2.3 9.10.58 0.40 5.4 3.6 9.00.58 0.25 5.4 2.2 9.0Table D. Exemplary dose combinationsEffective added Injection API Dose Apraglutide reconstitution volume [mg / vial] [mg] concentrationvolume [mL] [mL] [mg / mL]0.41 0.30 5.4 3.7 12.50.41 0.18 5.4 2.2 12.50.41 0.17 5.4 2.1 12.50.42 0.30 5.4 3.7 12.20.42 0.19 5.4 2.3 12.20.42 0.18 5.4 2.2 12.20.42 0.17 5.4 2.1 12.20.49 0.35 5.4 3.7 10.50.49 0.20 5.4 2.1 10.50.56 0.40 5.4 3.7 9.30.56 0.25 5.4 2.3 9.3Table E. Exemplary dose combinationsEffective added Injection API Dose Apraglutide reconstitution volume [mg / vial] [mg] concentrationvolume [mL] [mL] [mg / mL]0.40 0.30 5.4 3.8 12.80.40 0.18 5.4 2.3 12.80.40 0.17 5.4 2.2 12.80.47 0.35 5.4 3.8 11.00.47 0.20 5.4 2.2 11.00.47 0.19 5.4 2.1 11.00.48 0.35 5.4 3.8 10.70.48 0.20 5.4 2.1 10.70.54 0.40 5.4 3.8 9.60.54 0.25 5.4 2.4 9.60.55 0.40 5.4 3.8 9.40.55 0.25 5.4 2.4 9.4VECT-007 / 001WO (43765-02067)Table F. Exemplary dose combinationsEffective added Injection API Dose Apraglutide reconstitution volume [mg / vial] [mg] concentrationvolume [mL] [mL] [mg / mL]0.39 0.30 5.4 3.9 13.10.39 0.17 5.4 2.2 13.10.39 0.16 5.4 2.1 13.10.46 0.35 5.4 3.9 11.20.46 0.20 5.4 2.2 11.20.46 0.19 5.4 2.1 11.20.53 0.40 5.4 3.9 9.80.53 0.25 5.4 2.4 9.8Table G, Exemplary’ dose combinationsEffective added Injection API Dose Apraglutide reconstitution [mL] [mg / vial] [mg] concentrationvolume [mL] [mg / mL]0.38 0.30 5.4 4.0 13.40.38 0.17 5.4 2.3 13.40.38 0.16 5.4 2.1 13.40.45 0.35 5.4 4.0 11.40.45 0.20 5.4 2.3 11.40.45 0.19 5.4 2.2 11.40.45 0.18 5.4 2.1 11.40.58 0.45 5.4 4.0 9.00.58 0.25 5.4 2.2 9.00.59 0.45 5.4 4.0 8.80.59 0.25 5.4 2.2 8.8Table H. Exemplary dose combinationsEffective added Injection API Dose Apraglutide reconstitution volume [mg / vial] [mg] concentrationvolume [mL] [mL] [mg / mL]0.24 0.17 5.4 3.5 20.60.24 0.11 5.4 2.3 20.60.24 0.10 5.4 2.1 20.60.27 0.19 5.4 3.5 18.50.27 0.12 5.4 2.2 18.50.29 0.20 5.4 3.5 17.30.29 0.13 5.4 2.2 17.30.29 0.12 5.4 2.1 17.3VECT-007 / 001WO (43765-02067)Table I. Exemplary dose combinationsEffective added Injection API Dose Apraglutide reconstitution volume [mg / vial] [mg] concentrationvolume [mL] [mL] [mg / mL]0.25 0.18 5.4 3.6 19.80.25 0.11 5.4 2.2 19.80.26 0.19 5.4 3.6 19.10.26 0.12 5.4 2.3 19.10.26 0.11 5.4 2.1 19.10.28 0.20 5.4 3.6 17.80.28 0.13 5.4 2.3 17.80.28 0.12 5.4 2.1 17.8Table J. Exemplary dose combinationsEffective added Injection API Dose Apraglutide reconstitution volume [mg / vial] [mg] concentrationvolume [mL] [mL] [mg / mL]0.24 0.18 5.4 3.7 20.60.24 0.11 5.4 2.3 20.60.24 0.10 5.4 2.1 20.60.27 0.20 5.4 3.7 18.50.27 0.12 5.4 2.2 18.50.34 0.25 5.4 3.7 14.90.34 0.15 5.4 2.2 14.90.34 0.14 5.4 2.1 14.9Table K. Exemplary dose combinationsEffective added Injection API Dose Apraglutide reconstitution volume [mg / vial] [mg] concentrationvolume [mL] [mL] [mg / mL]0.25 0.19 5.4 3.8 19.80.25 0.11 5.4 2.2 19.80.26 0.20 5.4 3.8 19.10.26 0.11 5.4 2.1 19.10.26 0.12 5.4 2.3 19.10.33 0.25 5.4 3.8 15.30.33 0.15 5.4 2.3 15.30.33 0.14 5.4 2.1 15.3VECT-007 / 001WO (43765-02067)Table L. Exemplary dose combinationsEffective added Injection API Dose Apraglutide reconstitution volume [mg / vial] [mg] concentrationvolume [mL] [mL] [mg / mL]0.24 0.19 5.4 3.9 20.60.24 0.11 5.4 2.3 20.60.24 0.10 5.4 2.1 20.60.32 0.25 5.4 3.9 15.80.32 0.14 5.4 2.2 15.8Table M. Exemplary dose combinationsEffective added Injection API Dose Apraglutide reconstitution volume [mg / vial] [mg] concentrationvolume [mL] [mL] [mg / mL]0.25 0.20 5.4 4.0 19.80.25 0.11 5.4 2.2 19.8Table N. Exemplary dose combinationsEffective added Injection API Dose Apraglutide reconstitution volume [mg / vial] [mg] concentrationvolume [mL] [mL] [mg / mL]0.49 0.18 10.4 3.5 19.50.49 0.12 10.4 2.3 19.50.49 0.11 10.4 2.1 19.50.52 0.19 10.4 3.5 18.50.52 0.12 10.4 2.2 18.50.55 0.20 10.4 3.5 17.50.55 0.13 10.4 2.3 17.50.55 0.12 10.4 2.1 17.50.69 0.25 10.4 3.5 14.20.69 0.16 10.4 2.3 14.20.69 0.15 10.4 2.1 14.20.70 0.25 10.4 3.5 14.00.70 0.16 10.4 2.2 14.00.70 0.15 10.4 2.1 14.00.71 0.25 10.4 3.5 13.80.71 0.17 10.4 2.3 13.80.71 0.16 10.4 2.2 13.80.84 0.30 10.4 3.5 11.80.84 0.19 10.4 2.2 11.80.84 0.18 10.4 2.1 11.80.85 0.30 10.4 3.5 11.6VECT-007 / 001WO (43765-02067)0.85 0.20 10.4 2.3 11.60.85 0.19 10.4 2.2 11.60.85 0.18 10.4 2.1 11.60.86 0.30 10.4 3.5 11.50.86 0.20 10.4 2.3 11.50.86 0.19 10.4 2.2 11.50.86 0.18 10.4 2.1 11.51.13 0.40 10.4 3.5 8.91.13 0.25 10.4 2.2 8.91.14 0.40 10.4 3.5 8.81.14 0.25 10.4 2.2 8.8Table O. Exemplary dose combinationsEffective added Injection API Dose Apraglutide reconstitution volume [mg / vial] [mg] concentrationvolume [mL] [mL] [mg / mL]0.47 0.18 10.4 3.6 20.30.47 0.11 10.4 2.2 20.30.48 0.18 10.4 3.6 19.90.48 0.11 10.4 2.2 19.90.50 0.19 10.4 3.6 19.10.50 0.12 10.4 2.3 19.10.50 0.11 10.4 2.1 19.10.51 0.19 10.4 3.6 18.80.51 0.12 10.4 2.3 18.80.51 0.11 10.4 2.1 18.80.53 0.20 10.4 3.6 18.10.53 0.12 10.4 2.2 18.10.54 0.20 10.4 3.6 17.80.54 0.13 10.4 2.3 17.80.54 0.12 10.4 2.1 17.80.67 0.25 10.4 3.6 14.60.67 0.16 10.4 2.3 14.60.67 0.15 10.4 2.2 14.60.68 0.25 10.4 3.6 14.40.68 0.16 10.4 2.3 14.40.68 0.15 10.4 2.2 14.40.82 0.30 10.4 3.6 12.00.82 0.19 10.4 2.3 12.00.82 0.18 10.4 2.2 12.00.83 0.30 10.4 3.6 11.90.83 0.19 10.4 2.3 11.90.83 0.18 10.4 2.1 11.9VECT-007 / 001WO (43765-02067)0.96 0.35 10.4 3.6 10.40.96 0.20 10.4 2.1 10.40.97 0.35 10.4 3.6 10.30.97 0.20 10.4 2.1 10.31.10 0.40 10.4 3.6 9.11.10 0.25 10.4 2.3 9.11.11 0.40 10.4 3.6 9.01.11 0.25 10.4 2.3 9.01.12 0.40 10.4 3.6 8.91.12 0.25 10.4 2.2 8.9Table P. Exemplary dose combinationsEffective added Injection API Dose Apraglutide reconstitution volume [mg / vial] [mg] concentrationvolume [mL] [mL] [mg / mL]0.49 0.19 10.4 3.7 19.50.49 0.12 10.4 2.3 19.50.49 0.11 10.4 2.1 19.50.52 0.20 10.4 3.7 18.50.52 0.12 10.4 2.2 18.50.65 0.25 10.4 3.7 15.00.65 0.15 10.4 2.2 15.00.65 0.14 10.4 2.1 15.00.66 0.25 10.4 3.7 14.80.66 0.15 10.4 2.2 14.80.66 0.14 10.4 2.1 14.80.79 0.30 10.4 3.7 12.50.79 0.18 10.4 2.2 12.50.79 0.17 10.4 2.1 12.50.80 0.30 10.4 3.7 12.30.80 0.19 10.4 2.3 12.30.80 0.18 10.4 2.2 12.30.80 0.17 10.4 2.1 12.30.81 0.30 10.4 3.7 12.20.81 0.19 10.4 2.3 12.20.81 0.18 10.4 2.2 12.20.81 0.17 10.4 2.1 12.20.93 0.35 10.4 3.7 10.70.93 0.20 10.4 2.1 10.70.94 0.35 10.4 3.7 10.60.94 0.20 10.4 2.1 10.60.95 0.35 10.4 3.7 10.50.95 0.20 10.4 2.1 10.5VECT-007 / 001WO (43765-02067)1.07 0.40 10.4 3.7 9.31.07 0.25 10.4 2.3 9.31.08 0.40 10.4 3.7 9.31.08 0.25 10.4 2.3 9.31.09 0.40 10.4 3.7 9.21.09 0.25 10.4 2.3 9.2Table Q. Exemplary dose combinationsEffective added Injection API Dose Apraglutide reconstitution volume [mg / vial] [mg] concentrationvolume [mL] [mL] [mg / mL]0.47 0.19 10.4 3.8 20.30.47 0.11 10.4 2.2 20.30.48 0.19 10.4 3.8 19.90.48 0.11 10.4 2.2 19.90.50 0.20 10.4 3.8 19.10.50 0.12 10.4 2.3 19.10.50 0.11 10.4 2.1 19.10.51 0.20 10.4 3.8 18.80.51 0.12 10.4 2.3 18.80.51 0.11 10.4 2.1 18.80.64 0.25 10.4 3.8 15.20.64 0.15 10.4 2.3 15.20.64 0.14 10.4 2.1 15.20.78 0.30 10.4 3.8 12.60.78 0.18 10.4 2.3 12.60.78 0.17 10.4 2.1 12.60.91 0.35 10.4 3.8 10.90.91 0.20 10.4 2.2 10.90.91 0.19 10.4 2.1 10.90.92 0.35 10.4 3.8 10.80.92 0.20 10.4 2.2 10.80.92 0.19 10.4 2.1 10.8Table R. Exemplary dose combinationsEffective added Injection API Dose Apraglutide reconstitution volume [mg / vial] [mg] concentrationvolume [mL] [mL] [mg / mL]0.49 0.20 10.4 3.9 19.50.49 0.12 10.4 2.3 19.50.49 0.11 10.4 2.1 19.50.62 0.25 10.4 3.9 15.70.62 0.14 10.4 2.2 15.7VECT-007 / 001WO (43765-02067)0.63 0.25 10.4 3.9 15.40.63 0.15 10.4 2.3 15.40.63 0.14 10.4 2.2 15.40.75 0.30 10.4 3.9 13.10.75 0.17 10.4 2.2 13.10.75 0.16 10.4 2.1 13.10.76 0.30 10.4 3.9 12.90.76 0.18 10.4 2.3 12.90.76 0.17 10.4 2.2 12.90.76 0.16 10.4 2.1 12.90.88 0.35 10.4 3.9 11.30.88 0.20 10.4 2.3 11.30.88 0.19 10.4 2.1 11.30.89 0.35 10.4 3.9 11.10.89 0.20 10.4 2.2 11.10.89 0.19 10.4 2.1 11.10.90 0.35 10.4 3.9 11.00.90 0.20 10.4 2.2 11.00.90 0.19 10.4 2.1 11.0Table S. Exemplary dose combinationsEffective added Injection API Dose Apraglutide reconstitution volume [mL] [mg / vial] [mg] concentrationvolume [mL] [mg / mL]0.48 0.20 10.4 4.0 19.90.48 0.11 10.4 2.2 19.90.60 0.25 10.4 4.0 16.20.60 0.14 10.4 2.3 16.20.60 0.13 10.4 2.1 16.20.61 0.25 10.4 4.0 15.90.61 0.14 10.4 2.2 15.90.61 0.13 10.4 2.1 15.90.73 0.30 10.4 4.0 13.40.73 0.17 10.4 2.3 13.40.73 0.16 10.4 2.2 13.40.74 0.30 10.4 4.0 13.30.74 0.17 10.4 2.3 13.30.74 0.16 10.4 2.1 13.30.86 0.35 10.4 4.0 11.50.86 0.20 10.4 2.3 11.50.86 0.19 10.4 2.2 11.50.86 0.18 10.4 2.1 11.50.87 0.35 10.4 4.0 11.40.87 0.20 10.4 2.3 11.4VECT-007 / 001WO (43765-02067)0.87 0.19 10.4 2.2 11.41.12 0.45 10.4 4.0 8.91.12 0.25 10.4 2.2 8.91.13 0.45 10.4 4.0 8.91.13 0.25 10.4 2.2 8.91.14 0.45 10.4 4.0 8.81.14 0.25 10.4 2.2 8.8Table T. Exemplary dose combinationsEffective added Injection API Dose Apraglutide reconstitution volume [mg / vial] [mg] concentrationvolume [mL] [mL] [mg / mL]0.59 0.45 5.4 4.0 8.81.14 0.45 10.4 4.0 8.80.59 0.50 5.4 4.4 8.81.14 0.50 10.4 4.4 8.80.59 0.55 5.4 4.8 8.81.14 0.55 10.4 4.8 8.81.14 0.60 10.4 5.3 8.81.14 0.65 10.4 5.7 8.81.14 0.70 10.4 6.2 8.81.14 0.75 10.4 6.6 8.81.14 0.80 10.4 7.0 8.81.14 0.85 10.4 7.5 8.8Table U. Exemplary dose combinationsEffective added Injection API Dose [mg] Apraglutide reconstitution volume [mL] [mg / vial] concentrationvolume [mL] [mg / mL]0.25 0.20 5.4 4.0 19.80.28 0.25 5.4 4.5 17.80.34 0.30 5.4 4.5 14.90.38 0.30 5.4 4.0 13.40.40 0.35 5.4 4.5 12.80.45 0.35 5.4 4.0 11.40.46 0.40 5.4 4.5 11.20.52 0.45 5.4 4.5 10.00.52 0.40 5.4 4.0 10.00.58 0.50 5.4 4.5 9.00.58 0.45 5.4 4.0 9.00.59 0.45 5.4 4.0 8.8VECT-007 / 001WO (43765-02067)Table V. Exemplary dose combinationEffective added Injection API Dose Apraglutide reconstitution volume[mL] [mg / vial] [mg] concentrationvolume [mL] [mg / mL]0.48 0.35 10.4 7.0 19.90.48 0.30 10.4 6.0 19.90.48 0.25 10.4 5.0 19.90.48 0.20 10.4 4.0 19.90.51 0.40 10.4 7.5 18.80.52 0.35 10.4 6.5 18.50.52 0.30 10.4 5.5 18.50.53 0.25 10.4 4.5 18.10.54 0.25 10.4 4.5 17.80.55 0.40 10.4 7.0 17.50.56 0.35 10.4 6.0 17.20.58 0.45 10.4 7.5 16.70.58 0.30 10.4 5.0 16.70.60 0.40 10.4 6.5 16.20.60 0.25 10.4 4.0 16.20.61 0.25 10.4 4.0 15.90.62 0.35 10.4 5.5 15.70.65 0.50 10.4 7.5 15.00.65 0.40 10.4 6.0 15.00.65 0.30 10.4 4.5 15.00.68 0.45 10.4 6.5 14.40.68 0.35 10.4 5.0 14.40.69 0.35 10.4 5.0 14.20.70 0.50 10.4 7.0 14.00.71 0.40 10.4 5.5 13.80.72 0.55 10.4 7.5 13.60.73 0.30 10.4 4.0 13.40.74 0.45 10.4 6.0 13.30.74 0.30 10.4 4.0 13.30.76 0.50 10.4 6.5 12.90.76 0.35 10.4 4.5 12.90.77 0.55 10.4 7.0 12.80.77 0.35 10.4 4.5 12.80.79 0.60 10.4 7.5 12.50.79 0.40 10.4 5.0 12.50.80 0.45 10.4 5.5 12.30.81 0.45 10.4 5.5 12.20.82 0.50 10.4 6.0 12.00.83 0.55 10.4 6.5 11.90.83 0.50 10.4 6.0 11.9VECT-007 / 001WO (43765-02067)11.811.611.511.511.411.311.111.111.011.010.910.910.910.810.810.710.110.110.110.110.110.110.110.110.010.010.010.010.010.010.010.09.49.39.39.39.39.39.29.29.29.19.19.1VECT-007 / 001WO (43765-02067)1.11 0.55 10.4 5.0 9.01.11 0.50 10.4 4.5 9.01.12 0.50 10.4 4.5 8.91.12 0.45 10.4 4.0 8.91.13 0.85 10.4 7.5 8.91.13 0.45 10.4 4.0 8.91.14 0.85 10.4 7.5 8.81.14 0.80 10.4 7.0 8.81.14 0.45 10.4 4.0 8.8

[0620] In some embodiments, the concentration of apraglutide in the drug product concentration is about 8.8 mg / mL or more, about 10.0 mg / mL or more, about 12.0 mg / mL or more, about 15.0 mg / mL or more, or about 18.0 mg / mL or more. In some embodiments, the concentration of apraglutide in the drag product is about 20.6 mg / mL or less, about 20.0 mg / mL or less, about 18.0 mg / mL or less, about 15.0 mg / mL or less, or about 12.0 mg / mL or less. In some embodiments, the concentration of apraglutide in the drug product ranges from about 8.8 mg / mL to about 20.6 mg / mL.

[0621] In some embodiments, the administered dose is about 2.1 mg or more, about 2.2 mg or more, about 2.3 mg or more, about 2.5 mg or more, about 3.0 mg or more, about 3.5 mg or more, about 4.0 mg or more, about 4.5 mg or more, about 5.0 mg or more, about 5.5 mg or more, about 6,0 mg or more, about 6.5 mg or more, or about 7.0 mg or more. In some embodiments, the administered dose is about 7.5 mg or less, about 7.0 mg or less, about 6.5 mg or less, about 6.0 mg or less, about 5.5 mg or less, about 5.0 mg or less, about 4.5 mg or less, or about 4.0 mg or less.

[0622] In some embodiments, the administered dose ranges from about 2.1 mg to about 2.3 mg. In some embodiments, the administered dose ranges from about 3.5 mg to about 4.0 mg. In some embodiments, the administered dose ranges from about 4.0 mg to about 7.5 mg. In some embodiments, doses within the range of about 4,0 mg to about 7.5 mg are provided in increments of about 0.5 mg (e.g., about 4.0 mg, about 4.5 mg, about 5.0 mg, about 5.5 mg, about 6.0 mg, about 6.5 mg, about 7.0 mg, or about 7.5 mg).

[0623] In some embodiments, the apraglutide concentration in the reconstituted formulation is about 8.8 mg / mL, about 8.9 mg / mL, about 9.0 mg / mL, about 9, 1 mg / mL, about 9.2 mg / mL, about 9.3 mg / mL, about 9.4 mg / mL, about 9.5 mg / mL, about 9.6 mg / mL, about 9.7 mg / mL, about 9.8 mg / mL, about 9.9 mg / mL, about 10.0 mg / mL, about 10.1 mg / mL, about 10.2 mg / mL, about 10.3 mg / mL, about 10.4 mg / mL, about 10.5 mg / mL, about 10.6 mg / mL,VECT-007 / 001WO (43765-02067)about 10.7 mg / mL, about 10.8 mg / mL, about 10.9 mg / mL, about 11.0 mg / mL, about 11.1 mg / mL, about 11.2 mg / mL, about 11.3mg / mL, about 11.4 mg / mL, about 11.5 mg / mL, about 11.6 mg / mL, about 11.7 mg / mL, about 11.8 mg / mL, about 11.9 mg / mL, about 12.0 mg / mL, about 12.1 mg / mL, about 12.2 mg / mL, about 12.3 mg / mL, about 12.4 mg / mL, about 12.5 mg / mL, about 12.6 mg / mL, about 12.7 mg / mL, about 12.8 mg / mL, about 12.9mg / mL, about 13,0mg / mL, about 13.1 mg / mL, about 13.2 mg / mL, about 13,3 mg / mL, about 13.4 mg / mL, about 13.5 mg / mL, about 13.6mg / mL, about 13.7 mg / mL, about 13.8 mg / mL, about 13.9 mg / mL, about 14.0 mg / mL, about 14.1 mg / mL, about 14.2 mg / mL, about 14.3 mg / mL, about 14.4 mg / mL, about 14.5 mg / mL, about 14.6 mg / mL, about 14.7mg / mL, about 14.8 mg / mL, about 14.9 mg / mL, about 15.0mg / mL, about 15.1 mg / mL, about 15.2 mg / mL, about 15.3 mg / mL, about 15.4 mg / mL, about 15.5 mg / mL, about 15.6 mg / mL, about 15.7 mg / mL, about 15.8 mg / mL, about 15.9 mg / mL, about 16.0 mg / mL, about 16.1 mg / mL, about 16.2mg / mL, about 16.3 mg / mL, about 16,4 mg / mL, about 16.5 mg / mL, about 16.6 mg / mL, about 16.7 mg / mL, about 16.8 mg / mL, about 16.9 mg / mL, about 17.0 mg / mL, about 17.1 mg / mL, about 17.2 mg / mL, about 17.3 mg / mL, about 17.4 mg / mL, about 17.5 mg / mL, about 17.6 mg / mL, about 17.7 mg / mL, about 17.8 mg / mL, about 17,9 mg / mL, about 18.0 mg / mL, about 18.1 mg / mL, about 18.2 mg / mL, about 18.3 mg / mL, about 18.4 mg / mL, about 18.5 mg / mL, about 18.6 mg / mL, about 18.7 mg / mL, about 18.8 mg / mL, about 18.9 mg / mL, about 19.0 mg / mL, about 19.1 mg / mL, about 19.2 mg / mL, about 19,3 mg / mL, about 19.4 mg / mL, about 19.5 mg / mL, about 19,6 mg / mL, about 19.7 mg / mL, about 19.8 mg / mL, about 19.9 mg / mL, about 20.0 mg / mL, about 20.1 mg / mL, about 20.2 mg / mL, about 20.3 mg / mL, about 20.4 mg / mL, about 20.5 mg / mL, or about 20.6 mg / mL.

[0624] In some embodiments, a 5.4 mg / vial formulation is reconstituted with an effective added reconstitution volume of about 0.59 mL and an injection volume of about 0.40 mL is administered, resulting in an apraglutide concentration of about 8.8 mg / mL and an administered dose of about 3.5 mg.

[0625] In some embodiments, the pharmaceutical composition comprises a vial load of about 5.4 mg per vial, an effective added reconstitution volume of about 0.59 mL, an injection volume of about 0.40 mL, an administered dose of about 3.5 mg, and an apraglutide concentration of about 8.8 mg / mL.

[0626] In some embodiments, the pharmaceutical composition comprises a vial load of about 5.4 mg per vial, an effective added reconstitution volume of about 0.59 mL, an injectionVECT-007 / 001WO (43765-02067)volume of about 0.25 mL, an administered dose of about 2.2 mg, and an apraglutide concentration of about 8.8 mg / mL.

[0627] In some embodiments, the pharmaceutical composition comprises a vial load of about 5.4 mg per vial, an effective added reconstitution volume of about 0.29 mL, an injection volume of about 0.20 mL, an administered dose of about 3.5 mg, and an apraglutide concentration of about 17.3 mg / mL,

[0628] In some embodiments, the pharmaceutical composition comprises a vial load of about 5.4 mg per vial, an effective added reconstitution volume of about 0.29 mL, an injection volume of about 0.13 mL, an administered dose of about 2.2 mg, and an apraglutide concentration of about 17.3 mg / mL.

[0629] In some embodiments, the pharmaceutical composition comprises a vial load of about 5.4 mg per vial, an effective added reconstitution volume of about 0.36 mL, an injection volume of about 0.25 mL, an administered dose of about 3,5 mg, and an apraglutide concentration of about 14.1 mg / mL.

[0630] In some embodiments, the pharmaceutical composition comprises a vial load of about 5.4 mg per vial, an effective added reconstitution volume of about 0.36 mL, an injection volume of about 0.15 mL, an administered dose of about 2.1 mg, and an apraglutide concentration of about 14.1 mg / mL.

[0631] In some embodiments, the pharmaceutical composition comprises a vial load of about 10.4 mg per vial, an effective added reconstitution volume of about 0.55 mL, an injection volume of about 0.20 mL, an administered dose of about 3.5 mg, and an apraglutide concentration of about 17.5 mg / mL.

[0632] In some embodiments, the pharmaceutical composition comprises a vial load of about 10.4 mg per vial, an effective added reconstitution volume of about 0.55 mL, an injection volume of about 0.12 mL, an administered dose of about 2.1 mg, and an apraglutide concentration of about 17.5 mg / mL.

[0633] In some embodiments, the pharmaceutical composition comprises a vial load of about 5.4 mg per vial, an effective added reconstitution volume of about 0.36 mL, an injection volume of about 0.16 mL, an administered dose of about 2.3 mg, and an apraglutide concentration of about 14.1 mg / mL.

[0634] In some embodiments, the pharmaceutical composition comprises a vial load of about 5.4 mg per vial, an effective added reconstitution volume of about 0.44 mL, an injection volume of about 0.30 mL, an administered dose of about 3.5 mg, and an apraglutide concentration of about 11.7 mg / mL.VECT-007 / 001WO (43765-02067)

[0635] In some embodiments, the pharmaceutical composition comprises a vial load of about 5.4 mg per vial, an effective added reconstitution volume of about 0.44 mL, an injection volume of about 0.20 mL, an administered dose of about 2.3 mg, and an apraglutide concentration of about 11.7 mg / mL.

[0636] In some embodiments, the pharmaceutical composition comprises a vial load of about 5.4 mg per vial, an effective added reconstitution volume of about 0.44 mL, an injection volume of about 0.19 mL, an administered dose of about 2.2 mg, and an apraglutide concentration of about 11.7 mg / mL.

[0637] In some embodiments, the pharmaceutical composition comprises a vial load of about 5.4 mg per vial, an effective added reconstitution volume of about 0.44 mL, an injection volume of about 0.18 mL, an administered dose of about 2.1 mg, and an apraglutide concentration of about 11.7 mg / mL.

[0638] In some embodiments, the pharmaceutical composition comprises a vial load of about 5.4 mg per vial, an effective added reconstitution volume of about 0.51 mL, an injection volume of about 0.35 mL, an administered dose of about 3.5 mg, and an apraglutide concentration of about 10.1 mg / mL.

[0639] In some embodiments, the pharmaceutical composition comprises a vial load of about 5.4 mg per vial, an effective added reconstitution volume of about 0.51 mL, an injection volume of about 0.20 mL, an administered dose of about 2.0 mg, and an apraglutide concentration of about 10.1 mg / mL,

[0640] In some embodiments, the pharmaceutical composition comprises a vial load of about 5.4 mg per vial, an effective added reconstitution volume of about 0.35 mL, an injection volume of about 0.25 mL, an administered dose of about 3.6 mg, and an apraglutide concentration of about 14,5 mg / mL.

[0641] In some embodiments, the pharmaceutical composition comprises a vial load of about 5.4 mg per vial, an effective added reconstitution volume of about 0.35 mL, an injection volume of about 0.16 mL, an administered dose of about 2,3 mg, and an apraglutide concentration of about 14.5 mg / mL.

[0642] In some embodiments, the pharmaceutical composition comprises a vial load of about 5.4 mg per vial, an effective added reconstitution volume of about 0.35 mL, an injection volume of about 0.15 mL, an administered dose of about 2.2 mg, and an apraglutide concentration of about 14.5 mg / mL.

[0643] In some embodiments, the pharmaceutical composition comprises a vial load of about 5.4 mg per vial, an effective added reconstitution volume of about 0.43 mL, an injectionVECT-007 / 001WO (43765-02067)volume of about 0.30 mL, an administered dose of about 3.6 mg, and an apraglutide concentration of about 11.9 mg / mL.

[0644] In some embodiments, the pharmaceutical composition comprises a vial load of about 5.4 mg per vial, an effective added reconstitution volume of about 0.43 mL, an injection volume of about 0.19 mL, an administered dose of about 2.3 mg, and an apraglutide concentration of about 11.9 mg / mL,

[0645] In some embodiments, the pharmaceutical composition comprises a vial load of about 5.4 mg per vial, an effective added reconstitution volume of about 0.43 mL, an injection volume of about 0.18 mL, an administered dose of about 2.1 mg, and an apraglutide concentration of about 11.9 mg / mL.

[0646] In some embodiments, the pharmaceutical composition comprises a vial load of about 5.4 mg per vial, an effective added reconstitution volume of about 0.5 mL, an injection volume of about 0.35 mL, an administered dose of about 3,6 mg, and an apraglutide concentration of about 10.3 mg / mL.

[0647] In some embodiments, the pharmaceutical composition comprises a vial load of about 5.4 mg per vial, an effective added reconstitution volume of about 0.5 mL, an injection volume of about 0.20 mL, an administered dose of about 2.1 mg, and an apraglutide concentration of about 10.3 mg / mL.

[0648] In some embodiments, the pharmaceutical composition comprises a vial load of about 5.4 mg per vial, an effective added reconstitution volume of about 0.57 mL, an injection volume of about 0.40 mL, an administered dose of about 3.6 mg, and an apraglutide concentration of about 9.1 mg / mL.

[0649] In some embodiments, the pharmaceutical composition comprises a vial load of about 5,4 mg per vial, an effective added reconstitution volume of about 0.57 mL, an injection volume of about 0.25 mL, an administered dose of about 2.3 mg, and an apraglutide concentration of about 9.1 mg / mL.

[0650] In some embodiments, the pharmaceutical composition comprises a vial load of about 5.4 mg per vial, an effective added reconstitution volume of about 0.58 mL, an injection volume of about 0.40 mL, an administered dose of about 3.6 mg, and an apraglutide concentration of about 9.0 mg / mL.

[0651] In some embodiments, the pharmaceutical composition comprises a vial load of about 5.4 mg per vial, an effective added reconstitution volume of about 0.58 mL, an injection volume of about 0.25 mL, an administered dose of about 2.2 mg, and an apraglutide concentration of about 9.0 mg / mL.VECT-007 / 001WO (43765-02067)

[0652] In some embodiments, the pharmaceutical composition comprises a vial load of about 5.4 mg per vial, an effective added reconstitution volume of about 0.41 mL, an injection volume of about 0.30 mL, an administered dose of about 3.7 mg, and an apraglutide concentration of about 12.5 mg / mL.

[0653] In some embodiments, the pharmaceutical composition comprises a vial load of about 5.4 mg per vial, an effective added reconstitution volume of about 0.41 mL, an injection volume of about 0.18 mL, an administered dose of about 2.2 mg, and an apraglutide concentration of about 12.5 mg / mL.

[0654] In some embodiments, the pharmaceutical composition comprises a vial load of about 5.4 mg per vial, an effective added reconstitution volume of about 0.41 mL, an injection volume of about 0.17 mL, an administered dose of about 2.1 mg, and an apraglutide concentration of about 12.5 mg / mL.

[0655] In some embodiments, the pharmaceutical composition comprises a vial load of about 5.4 mg per vial, an effective added reconstitution volume of about 0.42 mL, an injection volume of about 0.30 mL, an administered dose of about 3.7 mg, and an apraglutide concentration of about 12.2 mg / mL.

[0656] In some embodiments, the pharmaceutical composition comprises a vial load of about 5.4 mg per vial, an effective added reconstitution volume of about 0.42 mL, an injection volume of about 0.19 mL, an administered dose of about 2.3 mg, and an apraglutide concentration of about 12.2 mg / mL,

[0657] In some embodiments, the pharmaceutical composition comprises a vial load of about 5.4 mg per vial, an effective added reconstitution volume of about 0.42 mL, an injection volume of about 0.18 mL, an administered dose of about 2.2 mg, and an apraglutide concentration of about 12,2 mg / mL.

[0658] In some embodiments, the pharmaceutical composition comprises a vial load of about 5.4 mg per vial, an effective added reconstitution volume of about 0.42 mL, an injection volume of about 0.17 mL, an administered dose of about 2,1 mg, and an apraglutide concentration of about 12.2 mg / mL.

[0659] In some embodiments, the pharmaceutical composition comprises a vial load of about 5.4 mg per vial, an effective added reconstitution volume of about 0.49 mL, an injection volume of about 0.35 mL, an administered dose of about 3.7 mg, and an apraglutide concentration of about 10.5 mg / mL.

[0660] In some embodiments, the pharmaceutical composition comprises a vial load of about 5.4 mg per vial, an effective added reconstitution volume of about 0.49 mL, an injectionVECT-007 / 001WO (43765-02067)volume of about 0.20 mL, an administered dose of about 2.1 mg, and an apraglutide concentration of about 10.5 mg / mL.

[0661] In some embodiments, the pharmaceutical composition comprises a vial load of about 5.4 mg per vial, an effective added reconstitution volume of about 0.56 mL, an injection volume of about 0.40 mL, an administered dose of about 3.7 mg, and an apraglutide concentration of about 9.3 mg / mL.

[0662] In some embodiments, the pharmaceutical composition comprises a vial load of about 5.4 mg per vial, an effective added reconstitution volume of about 0.56 mL, an injection volume of about 0.25 mL, an administered dose of about 2.3 mg, and an apraglutide concentration of about 9.3 mg / mL.

[0663] In some embodiments, the pharmaceutical composition comprises a vial load of about 5.4 mg per vial, an effective added reconstitution volume of about 0.40 mL, an injection volume of about 0.30 mL, an administered dose of about 3.8 mg, and an apraglutide concentration of about 12.8 mg / mL.

[0664] In some embodiments, the pharmaceutical composition comprises a vial load of about 5.4 mg per vial, an effective added reconstitution volume of about 0.40 mL, an injection volume of about 0.18 mL, an administered dose of about 2.3 mg, and an apraglutide concentration of about 12.8 mg / mL.

[0665] In some embodiments, the pharmaceutical composition comprises a vial load of about 5.4 mg per vial, an effective added reconstitution volume of about 0.40 mL, an injection volume of about 0.17 mL, an administered dose of about 2.2 mg, and an apraglutide concentration of about 12.8 mg / mL.

[0666] In some embodiments, the pharmaceutical composition comprises a vial load of about 5.4 mg per vial, an effective added reconstitution volume of about 0.47 mL, an injection volume of about 0.35 mL, an administered dose of about 3.8 mg, and an apraglutide concentration of about 11.0 mg / mL.

[0667] In some embodiments, the pharmaceutical composition comprises a vial load of about 5.4 mg per vial, an effective added reconstitution volume of about 0.47 mL, an injection volume of about 0.20 mL, an administered dose of about 2.2 mg, and an apraglutide concentration of about 11.0 mg / mL.

[0668] In some embodiments, the pharmaceutical composition comprises a vial load of about 5.4 mg per vial, an effective added reconstitution volume of about 0.47 mL, an injection volume of about 0.19 mL, an administered dose of about 2.1 mg, and an apraglutide concentration of about 11.0 mg / mL.VECT-007 / 001WO (43765-02067)

[0669] In some embodiments, the pharmaceutical composition comprises a vial load of about 5.4 mg per vial, an effective added reconstitution volume of about 0.48 mL, an injection volume of about 0.35 mL, an administered dose of about 3.8 mg, and an apraglutide concentration of about 10.7 mg / mL.

[0670] In some embodiments, the pharmaceutical composition comprises a vial load of about 5.4 mg per vial, an effective added reconstitution volume of about 0.48 mL, an injection volume of about 0.20 mL, an administered dose of about 2.1 mg, and an apraglutide concentration of about 10.7 mg / mL.

[0671] In some embodiments, the pharmaceutical composition comprises a vial load of about 5.4 mg per vial, an effective added reconstitution volume of about 0.54 mL, an injection volume of about 0.40 mL, an administered dose of about 3.8 mg, and an apraglutide concentration of about 9.6 mg / mL.

[0672] In some embodiments, the pharmaceutical composition comprises a vial load of about 5.4 mg per vial, an effective added reconstitution volume of about 0.54 mL, an injection volume of about 0.25 mL, an administered dose of about 2.4 mg, and an apraglutide concentration of about 9.6 mg / mL.

[0673] In some embodiments, the pharmaceutical composition comprises a vial load of about 5.4 mg per vial, an effective added reconstitution volume of about 0.55 mL, an injection volume of about 0.40 mL, an administered dose of about 3.8 mg, and an apraglutide concentration of about 9.4 mg / mL.

[0674] In some embodiments, the pharmaceutical composition comprises a vial load of about 5.4 mg per vial, an effective added reconstitution volume of about 0.55 mL, an injection volume of about 0.25 mL, an administered dose of about 2.4 mg, and an apraglutide concentration of about 9.4 mg / mL.

[0675] In some embodiments, the pharmaceutical composition comprises a vial load of about 5.4 mg per vial, an effective added reconstitution volume of about 0.39 mL, an injection volume of about 0.30 mL, an administered dose of about 3.9 mg, and an apraglutide concentration of about 13.1 mg / mL.

[0676] In some embodiments, the pharmaceutical composition comprises a vial load of about 5.4 mg per vial, an effective added reconstitution volume of about 0.39 mL, an injection volume of about 0.17 mL, an administered dose of about 2.2 mg, and an apraglutide concentration of about 13.1 mg / mL.

[0677] In some embodiments, the pharmaceutical composition comprises a vial load of about 5.4 mg per vial, an effective added reconstitution volume of about 0.39 mL, an injectionVECT-007 / 001WO (43765-02067)volume of about 0.16 mL, an administered dose of about 2.1 mg, and an apraglutide concentration of about 13.1 mg / mL.

[0678] In some embodiments, the pharmaceutical composition comprises a vial load of about 5.4 mg per vial, an effective added reconstitution volume of about 0.46 mL, an injection volume of about 0.35 mL, an administered dose of about 3.9 mg, and an apraglutide concentration of about 11.2 mg / mL.

[0679] In some embodiments, the pharmaceutical composition comprises a vial load of about 5.4 mg per vial, an effective added reconstitution volume of about 0.46 mL, an injection volume of about 0.20 mL, an administered dose of about 2.2 mg, and an apraglutide concentration of about 11.2 mg / mL.

[0680] In some embodiments, the pharmaceutical composition comprises a vial load of about 5.4 mg per vial, an effective added reconstitution volume of about 0.46 mL, an injection volume of about 0.19 mL, an administered dose of about 2.1 mg, and an apraglutide concentration of about 11.2 mg / mL.

[0681] In some embodiments, the pharmaceutical composition comprises a vial load of about 5.4 mg per vial, an effective added reconstitution volume of about 0.53 mL, an injection volume of about 0.40 mL, an administered dose of about 3.9 mg, and an apraglutide concentration of about 9.8 mg / mL.

[0682] In some embodiments, the pharmaceutical composition comprises a vial load of about 5.4 mg per vial, an effective added reconstitution volume of about 0.53 mL, an injection volume of about 0.25 mL, an administered dose of about 2.4 mg, and an apraglutide concentration of about 9.8 mg / mL.

[0683] In some embodiments, the pharmaceutical composition comprises a vial load of about 5.4 mg per vial, an effective added reconstitution volume of about 0.38 mL, an injection volume of about 0.30 mL, an administered dose of about 4.0 mg, and an apraglutide concentration of about 13.4 mg / mL.

[0684] In some embodiments, the pharmaceutical composition comprises a vial load of about 5.4 mg per vial, an effective added reconstitution volume of about 0.38 mL, an injection volume of about 0.17 mL, an administered dose of about 2.3 mg, and an apraglutide concentration of about 13.4 mg / mL.

[0685] In some embodiments, the pharmaceutical composition comprises a vial load of about 5.4 mg per vial, an effective added reconstitution volume of about 0.38 mL, an injection volume of about 0.16 mL, an administered dose of about 2.1 mg, and an apraglutide concentration of about 13.4 mg / mL.VECT-007 / 001WO (43765-02067)

[0686] In some embodiments, the pharmaceutical composition comprises a vial load of about 5.4 mg per vial, an effective added reconstitution volume of about 0.45 mL, an injection volume of about 0.35 mL, an administered dose of about 4.0 mg, and an apraglutide concentration of about 11.4 mg / mL.

[0687] In some embodiments, the pharmaceutical composition comprises a vial load of about 5.4 mg per vial, an effective added reconstitution volume of about 0.45 mL, an injection volume of about 0.20 mL, an administered dose of about 2.3 mg, and an apraglutide concentration of about 11.4 mg / mL.

[0688] In some embodiments, the pharmaceutical composition comprises a vial load of about 5.4 mg per vial, an effective added reconstitution volume of about 0.45 mL, an injection volume of about 0.19 mL, an administered dose of about 2.2 mg, and an apraglutide concentration of about 11.4 mg / mL.

[0689] In some embodiments, the pharmaceutical composition comprises a vial load of about 5.4 mg per vial, an effective added reconstitution volume of about 0.45 mL, an injection volume of about 0.18 mL, an administered dose of about 2.1 mg, and an apraglutide concentration of about 11.4 mg / mL.

[0690] In some embodiments, the pharmaceutical composition comprises a vial load of about 5.4 mg per vial, an effective added reconstitution volume of about 0.58 mL, an injection volume of about 0.45 mL, an administered dose of about 4.0 mg, and an apraglutide concentration of about 9.0 mg / mL.

[0691] In some embodiments, the pharmaceutical composition comprises a vial load of about 5.4 mg per vial, an effective added reconstitution volume of about 0.58 mL, an injection volume of about 0.25 mL, an administered dose of about 2.2 mg, and an apraglutide concentration of about 9.0 mg / mL.

[0692] In some embodiments, the pharmaceutical composition comprises a vial load of about 5.4 mg per vial, an effective added reconstitution volume of about 0.59 mL, an injection volume of about 0.45 mL, an administered dose of about 4.0 mg, and an apraglutide concentration of about 8.8 mg / mL.

[0693] In some embodiments, the pharmaceutical composition comprises a vial load of about 5.4 mg per vial, an effective added reconstitution volume of about 0.59 mL, an injection volume of about 0.25 mL, an administered dose of about 2.2 mg, and an apraglutide concentration of about 8.8 mg / mL.

[0694] In some embodiments, the pharmaceutical composition comprises a vial load of about 5.4 mg per vial, an effective added reconstitution volume of about 0.24 mL, an injectionVECT-007 / 001WO (43765-02067)volume of about 0.17 mL, an administered dose of about 3.5 mg. and an apraglutide concentration of about 20.6 mg / mL.

[0695] In some embodiments, the pharmaceutical composition comprises a vial load of about 5.4 mg per vial, an effective added reconstitution volume of about 0.24 mL, an injection volume of about 0.11 mL, an administered dose of about 2.3 mg, and an apraglutide concentration of about 20.6 mg / mL,

[0696] In some embodiments, the pharmaceutical composition comprises a vial load of about 5.4 mg per vial, an effective added reconstitution volume of about 0.24 mL, an injection volume of about 0.10 mL, an administered dose of about 2.1 mg, and an apraglutide concentration of about 20.6 mg / mL.

[0697] In some embodiments, the pharmaceutical composition comprises a vial load of about 5.4 mg per vial, an effective added reconstitution volume of about 0.27 mL, an injection volume of about 0.19 mL, an administered dose of about 3.5 mg, and an apraglutide concentration of about 18.5 mg / mL.

[0698] In some embodiments, the pharmaceutical composition comprises a vial load of about 5.4 mg per vial, an effective added reconstitution volume of about 0.27 mL, an injection volume of about 0.12 mL, an administered dose of about 2.2 mg, and an apraglutide concentration of about 18.5 mg / mL.

[0699] In some embodiments, the pharmaceutical composition comprises a vial load of about 5.4 mg per vial, an effective added reconstitution volume of about 0.29 mL, an injection volume of about 0.12 mL, an administered dose of about 2.1 mg, and an apraglutide concentration of about 17.3 mg / mL.

[0700] In some embodiments, the pharmaceutical composition comprises a vial load of about 5.4 mg per vial, an effective added reconstitution volume of about 0.25 mL, an injection volume of about 0.18 mL, an administered dose of about 3.6 mg, and an apraglutide concentration of about 19.8 mg / mL.

[0701] In some embodiments, the pharmaceutical composition comprises a vial load of about 5.4 mg per vial, an effective added reconstitution volume of about 0.25 mL, an injection volume of about 0.11 mL, an administered dose of about 2.2 mg, and an apraglutide concentration of about 19.8 mg / mL.

[0702] In some embodiments, the pharmaceutical composition comprises a vial load of about 5.4 mg per vial, an effective added reconstitution volume of about 0.26 mL, an injection volume of about 0.19 mL, an administered dose of about 3.6 mg, and an apraglutide concentration of about 19.1 mg / mL.VECT-007 / 001WO (43765-02067)

[0703] In some embodiments, the pharmaceutical composition comprises a vial load of about 5.4 mg per vial, an effective added reconstitution volume of about 0.26 mL, an injection volume of about 0.12 mL, an administered dose of about 2.3 mg, and an apraglutide concentration of about 19.1 mg / mL.

[0704] In some embodiments, the pharmaceutical composition comprises a vial load of about 5.4 mg per vial, an effective added reconstitution volume of about 0.26 mL, an injection volume of about 0.11 mL, an administered dose of about 2.1 mg, and an apraglutide concentration of about 19.1 mg / mL.

[0705] In some embodiments, the pharmaceutical composition comprises a vial load of about 5.4 mg per vial, an effective added reconstitution volume of about 0.28 mL, an injection volume of about 0.20 mL, an administered dose of about 3.6 mg, and an apraglutide concentration of about 17.8 mg / mL.

[0706] In some embodiments, the pharmaceutical composition comprises a vial load of about 5.4 mg per vial, an effective added reconstitution volume of about 0.28 mL, an injection volume of about 0.13 mL, an administered dose of about 2.3 mg, and an apraglutide concentration of about 17.8 mg / mL.

[0707] In some embodiments, the pharmaceutical composition comprises a vial load of about 5.4 mg per vial, an effective added reconstitution volume of about 0.28 mL, an injection volume of about 0.12 mL, an administered dose of about 2.1 mg, and an apraglutide concentration of about 17.8 mg / mL,

[0708] In some embodiments, the pharmaceutical composition comprises a vial load of about 5.4 mg per vial, an effective added reconstitution volume of about 0.24 mL, an injection volume of about 0.18 mL, an administered dose of about 3.7 mg, and an apraglutide concentration of about 20.6 mg / mL.

[0709] In some embodiments, the pharmaceutical composition comprises a vial load of about 5.4 mg per vial, an effective added reconstitution volume of about 0.27 mL, an injection volume of about 0.20 mL, an administered dose of about 3.7 mg, and an apraglutide concentration of about 18.5 mg / mL.

[0710] In some embodiments, the pharmaceutical composition comprises a vial load of about 5.4 mg per vial, an effective added reconstitution volume of about 0.34 mL, an injection volume of about 0.25 mL, an administered dose of about 3.7 mg, and an apraglutide concentration of about 14.9 mg / mL.

[0711] In some embodiments, the pharmaceutical composition comprises a vial load of about 5.4 mg per vial, an effective added reconstitution volume of about 0.34 mL, an injectionVECT-007 / 001WO (43765-02067)volume of about 0.15 mL, an administered dose of about 2.2 mg, and an apraglutide concentration of about 14.9 mg / mL.

[0712] In some embodiments, the pharmaceutical composition comprises a vial load of about 5.4 mg per vial, an effective added reconstitution volume of about 0.34 mL, an injection volume of about 0.14 mL, an administered dose of about 2.1 mg, and an apraglutide concentration of about 14.9 mg / mL,

[0713] In some embodiments, the pharmaceutical composition comprises a vial load of about 5.4 mg per vial, an effective added reconstitution volume of about 0.25 mL, an injection volume of about 0.19 mL, an administered dose of about 3.8 mg, and an apraglutide concentration of about 19.8 mg / mL.

[0714] In some embodiments, the pharmaceutical composition comprises a vial load of about 5.4 mg per vial, an effective added reconstitution volume of about 0.26 mL, an injection volume of about 0.20 mL, an administered dose of about 3.8 mg, and an apraglutide concentration of about 19.1 mg / mL.

[0715] In some embodiments, the pharmaceutical composition comprises a vial load of about 5.4 mg per vial, an effective added reconstitution volume of about 0.33 mL, an injection volume of about 0.25 mL, an administered dose of about 3.8 mg, and an apraglutide concentration of about 15.3 mg / mL.

[0716] In some embodiments, the pharmaceutical composition comprises a vial load of about 5.4 mg per vial, an effective added reconstitution volume of about 0.33 mL, an injection volume of about 0.15 mL,...

Claims

VECT-007 / 001WO (43765-02067)CLAIMSWhat is claimed is:

1. A method of treating short bowel syndrome (SBS) in a subject, the method comprising administering apraglutide, or a pharmaceutically acceptable salt thereof, to the subject once weekly, wherein:the subject has a body weight of 50 kg or greater, and the apraglutide or the pharmaceutically acceptable salt thereof is administered at a dose of about 3.5 mg; or the subject has a body weight less than 50 kg, and the apraglutide or the pharmaceutically acceptable salt thereof is administered at a dose of about 2,2 mg.

2. The method of claim 1, wherein the subject is 18 years or older.

3. Tlie method of claim 1 or 2, wherein the subject is dependent on parenteral support (PS).

4. The method of any one of claims 1-3, wherein the apraglutide or the pharmaceutically acceptable salt thereof is administered by subcutaneous injection.

5. The method of any one of claims 1-4, wherein the method comprises more than one dose of the apraglutide or pharmaceutically salt thereof, and the administration results in an increased plasma citrulline level in the subject, as measured at least 10 days after a last dose of the administration.

6. Tire method of any one of claims 1-5, wherein tire administration of apraglutide or pharmaceutically acceptable salt thereof results in:i) an increased intestinal absorption of dietary intake wet weight of the subject; ii) a decreased fecal output of the subject;iii) an increased absolute urine volume output of the subject, and / oriv) an increased intestinal absorption of energy of the subject.

7. The method of any one of claims 1-6, wherein a sodium salt of apraglutide is administered.

8. Tlie method of claim 7, wherein the sodium salt of apraglutide has a purity of no lessVECT-007 / 001WO (43765-02067)than about 94.0% as determined by high-performance liquid chromatography (HPLC).

9. Tire method of claim 7 or 8, wherein the sodium salt of apraglutide comprises no more than about 6.0% of the total amount of one or more impurities which may include Des-Gly4+ Aspartimide3, Asp33-OH, Des-Ser7, D-Asp3, P-Asp3, D-His1, or unspecified impurities as determined by HPLC.

10. Tire method of any one of claims 7-9, -wherein the sodium salt of apraglutide comprises no more than about 2.0% of P-Asp3as determined by HPLC.

11. The method of any one of claims 7-10, wherein the sodium salt of apraglutide comprises no more than about 2.0% of Des-Gly4+ Aspartimide3as determined by HPLC.

12. Tire method of any one of claims 7-11, wherein the sodium salt of apraglutide comprises no more than about 1.0% of D-Asp3as determined by HPLC.

13. The method of any one of claims 7-12, wherein the sodium salt of apraglutide comprises no more than about 1.0% of Des-Ser7as determined by HPLC.

14. Tlie method of any one of claims 7-13, wherein the sodium salt of apraglutide comprises no more than about 1.5% of Asp33-OH as determined by HPLC.

15. The method of any one of claims 7-14, wherein the sodium salt of apraglutide comprises no more than about 1.2% of D-His1as determined by HPLC,16. The method of any one of claims 7-15, wherein the sodium salt of apraglutide comprises:a) no more than about 2,0% of P-Asp3as determined by HPLC;b) no more than about 2.0% of Des-Gly4+ Aspartimide3as determined by HPLC; c) no more than about 1.0% of Des-Ser7as determined by HPLC;d) no more than about 1.5% of Asp33-OH as determined by HPLC;e) no more than about 1.0% of D-Asp3as determined by HPLC, and / orf) no more than about 1.2% of D-His1as determined by HPLC,VECT-007 / 001WO (43765-02067)provided that the total amount of the β-Asp3Des-Gly4+ Aspartimide’, Des-Ser', Asp33-OH, D-Asp3, D-His’, and unspecified apraglutide impurities is no more than about 6.0% as determined by HPLC.

17. The method of any one of claims 7-16, wherein the sodium salt of apraglutide comprises no more than about 0.5% of any unspecified impurity as determined by HPLC.

18. The method of any one of claims 7-17, wherein the sodium salt of apraglutide comprises no more than about 6.0% total impurities as determined by HPLC.

19. The method of any one of claims 7-18, wherein the sodium salt of apraglutide comprises no more than about 5 EU / mg of bacterial endotoxins.

20. Tire method of any one of claims 7-19, wherein a pharmaceutical composition comprising the apraglutide or the sodium salt thereof is administered.

21. The method of claim 20, wherein the pharmaceutical composition further comprises glycine, L-histidine, and mannitol.

22. The method of claim 20 or 21, wherein the pharmaceutical composition is a solution.

23. The method of any one of claims 20-22, wherein the pharmaceutical composition is suitable for subcutaneous injection.

24. The method of any one of claims 20-23, wherein the solution is prepared by reconstituting a lyophilized powder comprising the sodium salt of apraglutide with sterile water.

25. Tire method of any one of claims 20-24, wherein the pharmaceutical composition has a pH value ranging from about 8.0 to about 8.5.

26. The method of any one of claims 20-25, wherein the pharmaceutical composi tion has a pH value of about 8.3.

27. Tire method of claim 25 or 26, wherein:a) less than about 1.0% of apraglutide present in the pharmaceutical composition is an apraglutide dimer, andVECT-007 / 001WO (43765-02067)b) the pharmaceutical composition comprises apraglutide, or the sodium salt thereof, at a purity of more than 92.5%,as determined at 28 days storage of the pharmaceutical composition.

28. The method of any one of claims 20-27, wherein the pharmaceutical composition is administered via a syringe.

29. A pharmaceutical composition comprising:a sodium salt of apraglutide,glycine;L-histidine; andmannitol,wherein glycine, L-histidine and mannitol are in a w / w ratio (as measured to the corresponding weight of the free acid of apraglutide) as follows:glycine, present at a w / w ratio of about 0.15:1;L-histidine, present at a w / w ratio of about 0.31:1, andmannitol, present at a w / w ratio of about 4.6: 1.

30. The pharmaceutical composition of claim 29, comprising:about 16.5% w7w of the free acid of apraglutide;about 2.48% w7w of glycine;about 5,10% w / w of L-histidine; andabout 75.92% w / w of mannitol.

31. The pharmaceutical composition of claim 29, comprising:the sodium salt of apraglutide, wherein the corresponding weight of the free acid of apraglutide is about 5.2 mg,about 0,78 mg of glycine,about 1.61 mg of L-histidine, andabout 23.92 mg of mannitol.

32. The pharmaceutical composition of claim 29, comprising:the sodium salt of apraglutide, wherein the corresponding weight of the free acid of apraglutide is about 10.4 mg,about 1,56 mg of glycine.VECT-007 / 001WO (43765-02067)about 3.22 mg of L-histidine, andabout 47.84 mg of mannitol.

33. The pharmaceutical composition of claim 29, comprising:a) about 21.0 mg / ml ofthe free acid of apraglutide, about 3.1 mg / ml of glycine, about 6.4 mg / ml of L-histidine, about 95.0 mg / ml of mannitol, and sterile water;b) about 21.0 mg / ml of the free acid of apraglutide, about 3.2 mg / ml of glycine, about 6.5 mg / ml of L-histidine, about 97.0 mg / ml of mannitol, and sterile water; orc) about 10.0 mg / ml of the free acid of apraglutide, about 1.5 mg / ml of glycine, about 3.1 mg / ml of L-histidine, about 46.0 mg / ml mannitol, and sterile water.

34. A kit comprising:a lyophilized powder comprising a sodium salt of apraglutide, glycine, L-histidine, and mannitol, andsterile water.

35. A vial comprising a lyophilized powder, comprising:a) a sodium salt of apraglutide, wherein the corresponding weight of the free acid of apraglutide is about 5,2 mg;about 0.78 mg of glycine,about 1.61 mg of L-histidine, andabout 23.92 mg of mannitol, orb) a sodium salt of apraglutide, wherein the corresponding weight of the free acid of apraglutide is about 10.4 mg,about 1.56 mg of gly cine,about 3.22 mg of L-histidine, andabout 47.84 mg of mannitol.VECT-007 / 001WO (43765-02067)36. The pharmaceutical composition of claim 29, comprising: the sodium salt of apraglutide, wherein the corresponding weight of the free acid of apraglutide is about 5.4 mg, about 0.81 mg of glycine, about 1.67 mg of L-histidine, and about 24.84 mg of mannitol.

37. The pharmaceutical composition of claim 36, wherein, when reconstituted, the pharmaceutical composition comprises apraglutide at about 17.3 mg / mL, glycine at about 2.6 mg / mL, L-histidine at about 5.3 mg / mL, and mannitol at about 79.5 mg / mL, and wherein the effective added reconstitution volume is about 0.29 mL.

38. The pharmaceutical composition of claim 36, wherein, when reconstituted, the pharmaceutical composition comprises apraglutide at about 14.1 mg / mL, glycine at about 2.1 mg / mL, L-histidine at about 4.4 mg / mL, and mannitol at about 64.9 mg / mL, and wherein the effective added reconstitution volume is about 0.36 mL.

39. Tire pharmaceutical composition of claim 32, wherein, when reconstituted, the pharmaceutical composition comprises apraglutide at about 17.5 mg / mL, glycine at about 2.6 mg / mL, L-histidine at about 5.4 mg / mL, and mannitol at about 80.6 mg / mL, and wherein the effective added reconstitution volume is about 0.55 mL.

40. The pharmaceutical composition of any one of claims 29-33 or 36-39, wherein the reconstituted concentration is based on a displacement volume of about 0.69 mL per gram of lyophilized cake comprising apraglutide.

41. The pharmaceutical composition of any one of claims 29-33 or 36-40, wherein the pharmaceutical composition has a pH value of about 8.3.

42. The pharmaceutical composition of claim 41, wherein:a) less than or equal to about 1.0% of apraglutide present in the pharmaceutical composition is an apraglutide dimer, andb) tire pharmaceutical composition comprises apraglutide, or the sodium salt thereof, at a purity of more than 92.5%, as determined at 28 days storage of the pharmaceutical composition as a liquid,43. A method of treating short bowel syndrome (SBS) in a subject, the method comprising administering a pharmaceutical composition according to any one of claims 29-33 to theVECT-007 / 001WO (43765-02067)subject once weekly.

44. Tlie method of claim 43, wherein the pharmaceutical composition is administered by subcutaneous injection.

45. The method of claim 43 or 44, wherein the subject has a body weight of 50 kg or greater, and tire pharmaceutical composition comprises an administered dose of about 3.0 mg to about 4.0 mg of apraglutide.

46. The method of claim 43 or 44, wherein the subject has a body weight of 50 kg or greater, and the pharmaceutical composition comprises an administered dose of about 3.2 mg to about 3.6 mg of apraglutide.

47. Tire method of claim 43 or 44, wherein the subject has a body weight of 50 kg or greater, and the pharmaceutical composition comprises an administered dose of about 3.2 mg to about 3.5 mg of apraglutide.

48. The method of claim 43 or 44, wherein the subject has a body weight of 50 kg or greater, and the pharmaceutical composition comprises an administered dose of about 3.4 mg of apraglutide.

49. The method of claim 43 or 44, wherein the subject has a body weight of 50 kg or greater, and the pharmaceutical composition comprises an administered dose of about 3.5 mg of apraglutide.

50. Tlie method of claim 43 or 44, wherein the subject has a body weight less than 50 kg, and the pharmaceutical composition comprises an administered dose of about 1.0 mg to about 3.0 mg of apraglutide.

51. The method of claim 43 or 44, wherein the subject has a body weight less than 50 kg, and the pharmaceutical composition comprises an administered dose of about 1.0 mg to about 2.0 mg of apraglutide.

52. The method of claim 43 or 44, wherein the subject has a body weight less than 50 kg, and tire pharmaceutical composition comprises an administered dose of about 1.4 mg of apraglutide.

53. The method of claim 43 or 44, wherein the subject has a body weight less than 50 kg,VECT-007 / 001WO (43765-02067)and the pharmaceutical composition comprises an administered dose of about 2.0 mg to about 3.0 mg of apraglutide.

54. The method of claim 43 or 44, wherein the subject has a body weight less than 50 kg, and the pharmaceutical composition comprises an administered dose of about 2,5 mg of apraglutide.

55. Tire method of claim 43 or 44, wherein the subject has a body weight less than 50 kg, and the pharmaceutical composition comprises an administered dose of about 2.2 mg of apraglutide.

56. The method of any one of claims 43-55, wherein the pharmaceutical composition comprises a vial load of about 5.4 mg per vial or about 10.4 mg per vial.

57. The method of any one of claims 43-56, wherein the pharmaceutical composition comprises an apraglutide concentration from about 8.8 mg / mL to about 20,6 mg / mL.

58. The method of any one of claims 43-57, wherein the pharmaceutical composition comprises an effective added reconstitution volume from about 0,24 mL to about 1, 14 mL.

59. The method of any one of claims 43-58, wherein the pharmaceutical composition comprises an injection volume from about 0.1 mL to about 0.85 mL,60. The method of any one of claims 43-59, wherein the pharmaceutical composition is prepared by reconstituting a lyophilized powder comprising the sodium salt of apraglutide, glycine, L-histidine, and mannitol with sterile water for injection.

61. A kit comprising: a vial containing a composition according to any one of claims 29-33 or 36-42, wherein the composition is a lyophilized powder; and a container of sterile water for injection.

62. The kit of claim 61, further comprising a first syringe for transferring steri le water into the vial to reconstitute the lyophilized powder.

63. The kit of claim 62, further comprising a second syringe for withdrawing and administering the reconstituted solution.

64. The kit of claim 63, w'herein the first syringe has a capacity of about 1 mL andVECT-007 / 001WO (43765-02067)comprises low dead space, and the second syringe has a capacity of about 0.2 mL and comprises zero dead space.

65. The kit of any one of claims 61-64, further comprising a vial adapter configured to attach to the vial and pierce a septum of the vial.

66. The kit of claim 65, wherein the vial adapter comprises a female Luer-lock connection.

67. The kit of any one of claims 61-66, further comprising a needle for subcutaneous injection.

68. The kit of any one of claims 61-67, comprising supplies for administration of one dose, two doses, three doses, four doses, or more than four doses.

69. A pharmaceutical composition comprising:a vial load of about 5.4 mg per vial or about 10.4 mg per vial of apraglutide or a pharmaceutically acceptable salt thereof; glycine; L-histidine; and mannitol, and wherein the pharmaceutical composition is reconstituted with an effective added reconstitution volume ranging from about 0.24 mL to about 1.14 mL to provide an apraglutide concentration ranging from about 8.8 mg / mL to about 20.6 mg / mL.

70. Tire pharmaceutical composition of claim 69, wherein an injection volume ranging from about 0.1 mL to about 0.85 mL of the reconstituted pharmaceutical composition provides an administered apraglutide dose ranging from about 2.0 mg to about 7.5 mg.

71. The pharmaceutical composition of claim 69 or 70, wherein the administered dose of apraglutide is about 2.0 mg, about 2.1 mg, about 2.2 mg, about 2.3 mg, about 2.4 mg, about 3.5 mg, about 3.6 mg, about 3.7 mg, about 3.8 mg, about 3.9 mg, about 4.0 mg, about 4.4 mg, about 4.5 mg, about 4.8 mg, about 5.0 mg, about 5.3 mg, about 5.5 mg, about 5.7 mg, about 6.0 mg, about 6.2 mg, about 6.5 mg, about 6,6 mg, about 7.0 mg, or about 7,5 mg,72. The pharmaceutical composition of any one of claims 69-71, wherein the apraglutide concentration is about 8,8 mg / mL, about 8.9 mg / mL, about 9.0 mg / mL, about 9.1 mg / mL, about 9.2 mg / mL, about 9.3 mg / mL, about 9.4 mg / mL, about 9.6 mg / mL, about 9.8 mg / mL, about 10.0 mg / mL, about 10.1 mg / mL, about 10.3 mg / mL, about 10.4 mg / mL, about 10.5 mg / mL, about 10.6 mg / mL, about 10.7 mg / mL, about 10.8 mg / mL, about 10.9 mg / mL, aboutVECT-007 / 001WO (43765-02067)11.0 mg / mL, about 11.1 mg / mL, about 11.2 mg / mL, about 11.3 mg / mL, about 11.4 mg / mL, about 11.5 mg / mL, about 11.6 mg / mL, about 11.7 mg / mL, about 11.8 mg / mL, about 11.9 mg / mL, about 12.0 mg / mL, about 12.2 mg / mL, about 12.3 mg / mL, about 12.5 mg / mL, about 12.6 mg / mL, about 12.8 mg / mL, about 12.9 mg / mL, about 13.1 mg / mL, about 13.3 mg / mL, about 13.4 mg / mL, about 13.5 mg / mL, about 13.6 mg / mL, about 13.8 mg / mL, about 14.0 mg / mL, about 14.1 mg / mL, about 14.2 mg / mL, about 14.4 mg / mL, about 14.5 mg / mL, about 14.6 mg / mL, about 14.8 mg / mL, about 14.9 mg / mL, about 15.0 mg / mL, about 15.2 mg / mL, about 15.3 mg / mL, about 15.4 mg / mL, about 15.7 mg / mL, about 15.8 mg / mL, about 15.9 mg / mL, about 16.2 mg / mL, about 16.7 mg / mL, about 17.2 mg / mL, about 17.3 mg / mL, about 17.5 mg / mL, about 17.8 mg / mL, about 17.9 mg / mL, about 18.1 mg / mL, about 18.5 mg / mL, about 18.8 mg / mL, about 19.1 mg / mL, about 19.5 mg / mL, about 19.8 mg / mL, about 19.9 mg / mL, about 20.3 mg / mL, or about 20.6 mg / mL.

73. The pharmaceutical composition of any one of claims 69-72, wherein the effective added reconstitution volume is about 0.24 mL, about 0.25 mL, about 0.26 mL, about 0.27 mL, about 0.28 mL, about 0.29 mL, about 0.32 mL, about 0.33 mL, about 0.34 mL, about 0.35 mL, about 0.36 mL, about 0.38 mL, about 0.39 mL, about 0.40 mL, about 0.41 mL, about 0.42 mL, about 0.43 mL, about 0.44 mL, about 0.45 mL, about 0.46 mL, about 0.47 mL, about 0.48 mL, about 0.49 mL, about 0.50 mL, about 0.51 mL, about 0.52 mL, about 0.53 mL, about 0.54 mL, about 0.55 mL, about 0.56 mL, about 0.57 mL, about 0.58 mL, about 0.59 mL, about 0.60 mL, about 0.61 mL, about 0.62 mL, about 0.63 mL, about 0.64 mL, about 0.65 mL, about 0.66 mL, about 0.67 mL, about 0.68 mL, about 0.69 mL, about 0.70 mL, about 0.71 mL, about 0.72 mL, about 0.73 mL, about 0.74 mL, about 0.75 mL, about 0.76 mL, about 0.77 mL, about 0.78 mL, about 0.79 mL, about 0.80 mL, about 0.81 mL, about 0.82 mL, about 0.83 mL, about 0.84 mL, about 0.85 mL, about 0.86 mL, about 0.87 mL, about 0.88 mL, about 0.89 mL, about 0.90 mL, about 0.91 mL, about 0.92 mL, about 0.93 mL, about 0.94 mL, about 0.95 mL, about 0.96 mL, about 0.97 mL, about 0.99 mL, about 1.0 mL, about 1.06 mL, about 1.07 mL, about 1.08 mL, about 1.09 mL, about 1.10 mL, about 1.11 mL, about 1.12 mL, about 1.13 mL, or about 1.14 mL.

74. The pharmaceutical composition of any one of claims 69-73, wherein the injection volume is about 0.10 mL, about 0.11 mL, about 0.12 mL, about 0.13 mL, about 0.14 mL, about 0.15 mL, about 0.16 mL, about 0.17 mL, about 0.18 mL, about 0.19 mL, about 0.20 mL, about 0.25 mL, about 0.30 mL, about 0.35 mL, about 0.40 mL, about 0.45 mL, about 0.50 mL, aboutVECT-007 / 001WO (43765-02067)0.55 mL, about 0.60 mL, about 0.65 mL, about 0.70 mL, about 0.75 mL, about 0.80 mL, or about 0.85 mL.

75. A pharmaceutical composition for treating short bowel syndrome in a subject, the composition comprising:a vial load of about 5.4 mg per vial of apraglutide or a pharmaceutically acceptable salt thereof; glycine; L-histidine; and mannitol, wherein the pharmaceutical composition is reconstituted with an effective added reconstitution volume of about 0.59 mL, and wherein an injection volume of about 0.40 mL provides an administered dose of about 3.5 mg with an apraglutide concentration of about 8.8 mg / mL.

76. A pharmaceutical composition for treating short bowel syndrome in a subject, the composition comprising:a vial load of about 10.4 mg per vial of apraglutide or a pharmaceutically acceptable salt thereof; glycine; L-histidine; and mannitol, wherein the pharmaceutical composition is reconstituted with an effective added reconstitution volume of about 1.14 mL, and wherein an injection volume of about 0.40 mL provides an administered dose of about 3.5 mg at an apraglutide concentration of about 8.8 mg / mL.

77. A pharmaceutical composition for treating short bowel syndrome in a subject, the composition comprising:a vial load of about 5.4 mg per vial of apraglutide or a pharmaceutically acceptable salt thereof; glycine; L-histidine; and mannitol,wherein the pharmaceutical composition is reconstituted with an effective added reconstitution volume of about 0.24 mL, andwherein an injection volume of about 0.17 mL provides an administered dose of about 3.5 mg at an apraglutide concentration of about 20.6 mg / mL.

78. The pharmaceutical composition of any one of claims 75-77, wherein the subject has a body weight of 50 kg or greater.

79. A pharmaceutical composition for treating short bowel syndrome, the compositionVECT-007 / 001WO (43765-02067)comprising:a vial load of about 5.4 mg per vial or about 10.4 mg per vial of apraglutide or a pharmaceutically acceptable salt thereof; glycine; L-histidine; and mannitol,wherein the pharmaceutical composition is reconstituted to provide an administered dose from about 4.0 mg to about 7.5 mg.

80. The pharmaceutical composition of claim 79, wherein the administered dose is about 4.0 mg, about 4.5 mg, about 5.0 mg, about 5.5 mg, about 6.0 mg, about 6.5 mg, about 7.0 mg, or about 7.5 mg.

81. The pharmaceutical composition of claim 79 or 80, wherein the vial load is about 10.4 mg per vial, the effective added reconstitution volume is about 1.14 mL, and the concentration of apraglutide in the drug product is about 8.8 mg / mL.

82. The pharmaceutical composition of claim 81, wherein the injection volume is about 0.45 mL, about 0.50 mL, about 0.55 mL, about 0.60 mL, about 0.65 mL, about 0.70 mL, about 0.75 mL, about 0.80 mL, or about 0.85 mL.

83. The kit of claim 34, wherein the lyophilized powder comprises: a) a sodium salt of apraglutide, wherein the corresponding weight of the free acid of apraglutide is about 5.4 mg, about 0.81 mg of glycine, about 1.67 mg of L-histidine, and about 24.84 mg of mannitol; b) a sodium salt of apraglutide, wherein the corresponding weight of the free acid of apraglutide is about 10.4 mg, about 1.56 mg of glycine, about 3.22 mg of L-histidine, and about 47.84 mg of mannitol; or c) a sodium salt of apraglutide, wherein the corresponding weight of the free acid of apraglutide is about 5.2 mg, about 0.78 mg of glycine, about 1.61 mg of L-histidine, and about 23.92 mg of mannitol.

84. The kit of claim 83, wherein the sterile water is provided in an amount of about 0.23 mL, about 0.29 mL, about 0.36 mL, about 0.45 mL, about 0.55 mL, about 0.59 mL, or about 1.14 mL.

85. The kit of any one of claims 34, 61-68, or 83-84, further comprising: a first syringe for transferring sterile water into the vial; a second syringe for withdrawing and administering the reconstituted solution; and a vial adapter configured to attach to the vial.VECT-007 / 001WO (43765-02067)86. The kit of claim 85, wherein the vial adapter comprises a female Luer-lock connection that attaches to the first syringe or the second syringe.

87. The kit of claim 85 or 86, further comprising a needle for subcutaneous injection that couples to the second syringe.

88. A pharmaceutical composition comprising apraglutide or a pharmaceutically acceptable salt thereof,wherein the pharmaceutical composition is characterized by: a vial load selected from about 5.4 mg per vial or about 10.4 mg per vial; an effective added reconstitution volume selected from the range of about 0.23 mL to about 1.14 mL; an apraglutide concentration selected from the range of about 8.8 mg / mL to about 20.6 mg / mL; and an injection volume selected from the range of about 0.1 mL to about 0.85 mL,wherein the combination of the vial load, effective added reconstitution volume, the concentration of apraglutide in the drug product, and injection volume provides an administered dose from about 2.0 mg to about 7.5 mg.

89. The pharmaceutical composition of claim 88, wherein the administered dose is: a) about 2.1 mg to about 2.3 mg for subjects with body weight less than 50 kg, or about 3.5 mg to about 4.0 mg for subjects with body weight of 50 kg or greater; orb) about 1.4 mg for subjects with body weight less than 50 kg, or about 3.5 mg for subjects with body weight of 50 kg or greater.

90. The pharmaceutical composition of claim 88, wherein the administered dose is about 4.0 mg to about 7.5 mg.

91. The pharmaceutical composition of any one of claims 88-90, further comprising glycine, L-histidine, and mannitol.

92. The pharmaceutical composition of any one of claims 88-91, wherein the pharmaceutical composition has a pH value of about 8.3,93. A method of preparing a pharmaceutical composition for treating short bowel syndrome in a subject, the method comprising:VECT-007 / 001WO (43765-02067)providing a vial containing a lyophilized powder comprising apraglutide or a pharmaceutically acceptable salt thereof, glycine, L-histidine, and mannitol;adding sterile water for injection to the vial in an effective added reconstitution volume ranging from about 0.23 mL to about 1.14 mL;admixing to form a reconstituted solution having an apraglutide concentration from about 8.8 mg / mL to about 20.6 mg / mL; andwithdrawing an injection volume from about 0.1 mL to about 0.85 mL to provide an administered dose from about 2,0 mg to about 7.5 mg.

94. The method of claim 93, wherein the vial contains about 5.4 mg or about 10.4 mg of apraglutide or a pharmaceutically acceptable salt thereof.

95. The method of claim 93 or 94, wherein the reconstituted solution has a pH value of about 8.3.

96. The method of any one of claims 93-95, wherein the administered dose is selected based on the subject's body weight,wherein subjects with body weight less than 50 kg receive an administered dose of about 2.1 mg to about 2.3 mg, and subjects with body weight of 50 kg or greater receive an administered dose of about 3.5 mg to about 4.0 mg.

97. A pharmaceutical composition comprising:(a) apraglutide in an amount of about 8 % to about 25 % by -weight of total solids; (b) a buffering agent in an amount of about 0.75 % to about 4.25 % by weight;(c) a stabilizing agent in an amount of about 2.55 % to about 7.65 % by weight; and (d) a bulking agent in an amount of about 63.15 % to about 88.65 % by weight, 98. The pharmaceutical composition of claim 97, wherein the buffering agent comprises glycine.

99. The pharmaceutical composition of claim 97 or claim 98, wherein the stabilizing agent comprises L-histidine.

100. Th e pharmaceuti cal composition of any one of claims 97-99, wherei n the bulki ng agentVECT-007 / 001WO (43765-02067)comprises mannitol.

101. Tlie pharmaceutical composition of any one of claims 97-100, wherein the apraglutide is present as a salt.

102. A pharmaceutical composition comprising:(a) apraglutide in an amount of about 15.5% to about 17.5% by weight of total solids; (b) glycine in an amount of about 1.25% to about 3.75% by weight of total solids; (c) L-histidine in an amount of about 2.55% to about 7.65% by w eight of total solids; and(d) mannitol in an amount of about 63.15% to about 88.65% by weight of total solids.

103. The pharmaceutical composition of claim 102, wherein glycine is present in an amount of about 1.98% to about 2.98% by weight of total solids.

104. Tlie pharmaceutical composition of claim 102, wherein glycine is present in an amount of about 2,28% to about 2.68% by weight of total solids.

105. The pharmaceutical composition of claim 102, wherein glycine is present in an amount of about 2.48%.

106. The pharmaceutical composition of claim 102, wherein mannitol is present in an amount of about 74.92% to about 76.92% by weight of total solids.

107. The pharmaceutical composition of claim 102, wherein mannitol is present in an amount of about 75.92% by weight of total solids.

108. The pharmaceutical composition of claim 102, wherein L-histidine is present in an amount of about 3.50% to about 6.70% by weight of total solids.

109. Tire pharmaceutical composition of claim 102, wherein L-histidine is present in an amount of about 4.35% to about 5.85% by weight of total solids.

110. The pharmaceutical composition of claim 102, wherein L-histidine is present in an amount of about 4.90% to about 5.30% by weight of total solids.

111. Tlie pharmaceutical composition of claim 102, wherein L-histidine is present in an amount of about 5.10% by weight of total solids.VECT-007 / 001WO (43765-02067)112. The pharmaceutical composition of claim 102, wherein apraglutide is present in an amount of about 16.5% by weight of total solids.

113. The pharmaceutical composition of claim 102, wherein apraglutide is present in an amount of about 15.5% to about 17.5% by weight in combination with glycine at about 2.48%, L-histidine at about 5.10%, and mannitol at about 75.92% by weight of total solids.

114. Tire pharmaceutical composition of claim 102, wherein apraglutide is present in an amount of about 15.5% to about 17.5% by weight in combination with glycine at about 2.48%, L-histidine at about 4.90% to about 5.30%, and mannitol at about 74.92% to about 76.92% by weight of total solids,115. The pharmaceutical composition of claim 102, wherein the composition is in lyophilized form.

116. The pharmaceutical composition of claim 102, wherein glycine serves as a buffering agent, L-histidine serves as a stabilizing agent, and mannitol serves as a bulking agent.

117. Tire pharmaceutical composition of claim 102, wherein apraglutide is present as the sodium salt.

118. The pharmaceutical composition of claim 102, wherein mannitol is crystalline.

119. Tire pharmaceutical composition of claim 102, wherein the components are combined in aqueous solution prior to lyophilization.

120. A pharmaceutical composition comprising: (a) apraglutide in an amount of about 15.5% to about 17.5% by weight of total solids; (b) a buffering agent in an amount of about 1.25% to about 3.75% by weight of total solids; (c) a stabilizing agent in an amount of about 2.55% to about 7.65% by weight of total solids; (d) a bulking agent in an amount of about 63.15% to about 88.65% by weight of total solids.

121. The pharmaceutical composition of claim 120, wherein the buffering agent comprises glycine.

122. Tire pharmaceutical composition of claim 120, wherein the stabilizing agent comprises L-histidine.VECT-007 / 001WO (43765-02067)123. The pharmaceutical composition of claim 120, wherein the bulking agent comprises mannitol.

124. The pharmaceutical composition of any one of claims 120-123, wherein the buffering agent is present in an amount of about 1.98% to about 2.98% by weight of total solids.

125. The pharmaceutical composition of any one of claims 120-123, wherein the buffering agent is present in an amount of about 2.28% to about 2.68% by weight of total solids.

126. The pharmaceutical composition of any one of claims 120-123, wherein the buffering agent is present in an amount of about 2.48% by weight of total solids.

127. Tire pharmaceutical composition of any one of claims 120-123, wherein the stabilizing agent is present in an amount of about 3.50% to about 6.70% by weight of total solids.

128. The pharmaceutical composition of any one of claims 120-123, wherein the stabilizing agent is present in an amount of about 4.35% to about 5.85% by weight of total solids.

129. Tire pharmaceutical composition of any one of claims 120-123, wherein the stabilizing agent is present in an amount of about 4.90% to about 5.30% by weight of total solids.

130. The pharmaceutical composition of any one of claims 120-123, wherein the stabilizing agent is present in an amount of about 5.10% by weight of total solids.

131. Tlie pharmaceutical composition of any one of claims 120-123, wherein the bulking agent is present in an amount of about 69.15% to about 82.65% by weight of total solids.

132. The pharmaceutical composition of any one of claims 120-123, wherein the bulking agent is present in an amount of about 72.92% to about 78.92% by weight of total solids.

133. The pharmaceutical composition of any one of claims 120-123, wherein the bulking agent is present in an amount of about 74.92% to about 76.92% by weight of total solids.

134. The pharmaceutical composition of any one of claims 120-123, wherein the bulking agent is present in an amount of about 75.92% by weight of total solids.

135. The pharmaceutical composition of claim 120, wherein apraglutide is present as a sodium salt.VECT-007 / 001WO (43765-02067)136. The pharmaceutical composition of claim 120. wherein the composition is lyophilized.

137. Tire pharmaceutical composition of claim 120, wherein the bulking agent is crystalline mannitol.

138. The pharmaceutical composition of claim 120, wherein the components (a) to (d) are dissolved in aqueous solution prior to lyophilization.

139. The pharmaceutical composition of claim 120, wherein the buffering agent and stabilizing agent are present in molar ratios between about 1:1 and about 1:2.

140. A pharmaceutical composition comprising: (a) apraglutide in an amount of about 0.4mol% to about 1.4mol%; (b) a buffering agent in an amount of about 3.4mol% to about 10.2 mol%; (c) a stabilizing agent in an amount of about 3.4 mol% to about 10.2 mol%; (d) a bulking agent in an amount of about 78.0 mol% to about 93.2 mol%.

141. The pharmaceutical composition of claim 140, wherein the buffering agent comprises glycine.

142. Tlie pharmaceutical composition of claim 140, w herein the stabilizing agent comprises L-histidine.

143. The pharmaceutical composition of claim 140, wherein the bulking agent comprises mannitol,144. The pharmaceutical composition of any one of claims 140-143, wherein apraglutide is present in an amount of about 0.5 mol% to about 1.3 mol%.

145. Tire pharmaceutical composition of any one of claims 140-143, wherein apraglutide is present in an amount of about 0.7 mol% to about 1.1 mol%.

146. The pharmaceutical composition of any one of claims 140-143, wherein apraglutide is present in an amount of about 0.8 mol% to about 1.0 mol%.

147. Tire pharmaceutical composition of any one of claims 140-143, wherein apraglutide is present in an amount of about 0.9 mol%.

148. The pharmaceutical composition of any one of claims 140-143, wherein the buffering agent is present in an amount of about 4.77 mol% to about 8.77 mol%.VECT-007 / 001WO (43765-02067)149. The pharmaceutical composition of any one of claims 140-143, wherein the buffering agent is present in an amount of about 5.77 mol% to about 7.77 mol%.

150. The pharmaceutical composition of any one of claims 140-143, wherein the buffering agent is present in an amount of about 6.47 mol% to about 7.07 mol%.

151. The pharmaceutical composition of any one of claims 140-143, wherein the buffering agent is present in an amount of about 6.77 mol%.

152. The pharmaceutical composition of any one of claims 140-143, wherein the stabilizing agent is present in an amount of about 4.76 mol% to about 8.76 mol%.

153. Tire pharmaceutical composition of any one of claims 140-143, wherein the stabilizing agent is present in an amount of about 5.76 mol% to about 7.76 mol%.

154. The pharmaceutical composition of any one of claims 140-143, wherein the stabilizing agent is present in an amount of about 6.46 mol% to about 7.07 mol%.

155. Tire pharmaceutical composition of any one of claims 140-143, wherein the stabilizing agent is present in an amount of about 6.76 mol%.

156. The pharmaceutical composition of any one of claims 140-143, wherein the bulking agent is present in an amount of about 81.57 mol% to about 89.57 mol%.

157. The pharmaceutical composition of any one of claims 140-143, wherein the bulking agent is present in an amount of about 83.57 mol% to about 87.57 mol%.

158. The pharmaceutical composition of any one of claims 140-143, wherein the bulking agent is present in an amount of about 84.87 mol% to about 86.27 mol%.

159. The pharmaceutical composition of any one of claims 140-143, wherein the bulking agent is present in an amount of about 85.57 mol%.

160. A pharmaceutical composition comprising: (a) apraglutide in an amount of about 0.4 mol% to about 1.4 mol%; (b) glycine in an amount of about 3.4 mol% to about 10.2 mol%; (c) L-histidine in an amount of about 3.4 mol% to about 10.2 mol%; (d) mannitol in an amount of about 78.0 mol% to about 93.2 mol%.

161. The pharmaceutical composition of claim 160, wherein apraglutide is present in anVECT-007 / 001WO (43765-02067)amount of about 0.5 mol% to about 1.3 mol%.

162. Tire pharmaceutical composition of claim 160, wherein apraglutide is present in an amount of about 0.7 mol% to about 1.1 mol%.

163. The pharmaceutical composition of claim 160, wherein apraglutide is present in an amount of about 0.8 mol% to about 1.0 mol%.

164. The pharmaceutical composition of claim 160, wherein apraglutide is present in an amount of about 0.9 mol%.

165. The pharmaceutical composition of claim 160, wherein glycine is present in an amount of about 4.8 mol% to about 8.8 mol %,166. The pharmaceutical composition of claim 160, wherein glycine is present in an amount of about 5.8 mol% to about 7.8 mol%.

167. The pharmaceutical composition of claim 160, wherein glycine is present in an amount of about 6.5 mol% to about 7.1 mol%.

168. The pharmaceutical composition of claim 160, wherein glycine is present in an amount of about 6.8 mol%.

169. The pharmaceutical composition of claim 160, wherein L-histidine is present in an amount of about 4.8 mol% to about 8.8 mol%.

170. The pharmaceutical composition of claim 160, wherein L-histidine is present in an amount of about 5.8 mol% to about 7.8 mol%.

171. The pharmaceutical composition of claim 160, wherein L-histidine is present in an amount of about 6.5 mol% to about 7.1 mol%.

172. The pharmaceutical composition of claim 160, wherein L-histidine is present in an amount of about 6.8 mol%,173. The pharmaceutical composition of claim 160, wherein mannitol is present in an amount of about 81.6 mol% to about 89.6 mol%.

174. The pharmaceutical composition of claim 160, wherein mannitol is present in anVECT-007 / 001WO (43765-02067)amount of about 83.6 mol% to about 87.6 mol%.

175. The pharmaceutical composition of claim 160, wherein mannitol is present in an amount of about 84.9 mol% to about 86.3 mol%.

176. The pharmaceutical composition of claim 160, wherein mannitol is present in an amount of about 85.6 mol%.

177. The pharmaceutical composition of claim 160, wherein apraglutide is present as a sodium salt.

178. The pharmaceutical composition of claim 160, wherein the composition is lyophilized.

179. The pharmaceutical composition of claim 160, wherein the components (a) to (d) are dissolved in aqueous solution prior to lyophilization,180. The pharmaceutical composition of any one of claims 29-33, 36-42, 69-82, 88-92, or 97-179, wherein the pharmaceutical composition comprises no more than about 6.0% of the total amount of one or more impurities which may include Des-Gly4+ Aspartimide3, Asp33-OH, Des-Ser7+ Aspartimide33, p-Asp3, D-Asp’, or unspecified impurities as determined by HPLC.

181. The pharmaceutical composition of any one of claims 29-33, 36-42, 69-82, 88-92, or 97-180, wherein the pharmaceutical composition comprises no more than about 2.5% of Des-Gly4+ Aspartimide3as determined by HPLC.

182. The pharmaceutical composition of any one of claims 29-33, 36-42, 69-82, 88-92, or 97-181, wherein the pharmaceutical composition comprises no more than about 2.0% of Asp33-OH as determined by HPLC.

183. The pharmaceutical composition of any one of claims 29-33, 36-42, 69-82, 88-92, or 97-182, wherein the pharmaceutical composition comprises no more than about 1.0% of Des-Ser7+ Aspartimide33as determined by HPLC.

184. The pharmaceutical composition of any one of claims 29-33, 36-42, 69-82, 88-92, or 97-183, wherein the pharmaceutical composition comprises no more than about 3.0% of P- Asp3as determined by HPLC.VECT-007 / 001WO (43765-02067)185. The pharmaceutical composition of any one of claims 29-33, 36-42, 69-82, 88-92, or 97-184, wherein the pharmaceutical composition comprises no more than about 1.0% of D-Asp3as determined by HPLC.

186. The pharmaceutical composition of any one of claims 29-33, 36-42, 69-82, 88-92, or 97-185, wherein the pharmaceutical composition comprises:a) no more than about 2.5% of Des-Gly4+ Aspartimide3as determined by HPLC; b) no more than about 2.0% of Asp33-OH as determined by HPLC;c) no more than about 1.0% of Des-Ser7+ Aspartimide33as determined by HPLC; d) no more than about 3.0% of β-Asp3as determined by HPLC, and / ore) no more than about 1.0% of D-Asp3as determined by HPLC,provided that the total amount of the Des-Gly4+ Aspartimide3, Asp33-OH, Des-Ser7+ Aspartimide’3, p-Asp3, D-Asp3, and unspecified apraglutide impurities is no more than about 6.0% as determined by HPLC,187. The pharmaceutical composition of any one of claims 29-33, 36-42, 69-82, 88-92, or 97-186, wherein the pharmaceutical composition comprises no more than about 0.5% of any unspecified impurity as determined by HPLC.

188. The pharmaceutical composition of any one of claims 29-33, 36-42, 69-82, 88-92, or 97-187, wherein the pharmaceutical composition comprises no more than about 6.0% total impurities as determined by HPLC.

189. The pharmaceutical composition of any one of claims 29-33, 36-42, 69-82, 88-92, or 97-188, wherein the pharmaceutical composition comprises no more than about 25 EU / mg of bacterial endotoxins.

190. A method of treating short bowel syndrome (SBS) in a subject, the method comprising administering a pharmaceutical composition according to any one of claims 88-92 or 97-189 to the subject once weekly.

191. The method of claim 190, wherein the pharmaceutical composition is administered by subcutaneous injection.VECT-007 / 001WO (43765-02067)192. The method of claim 190 or 191, wherein the subject has a body weight of 50 kg or greater, and the pharmaceutical composition comprises an administered dose of about 3.0 mg to about 4.0 mg of apraglutide.

193. The method of claim 190 or 191, wherein the subject has a body weight of 50 kg or greater, and the pharmaceutical composition comprises an administered dose of about 3.2 mg to about 3.6 mg of apraglutide.

194. The method of claim 190 or 191, wherein the subject has a body weight of 50 kg or greater, and the pharmaceutical composition comprises an administered dose of about 3.2 mg to about 3.5 mg of apraglutide.

195. The method of claim 190 or 191, wherein the subject has a body weight of 50 kg or greater, and the pharmaceutical composition comprises an administered dose of about 3,4 mg of apraglutide.

196. The method of claim 190 or 191, wherein the subject has a body weight of 50 kg or greater, and the pharmaceutical composition comprises an administered dose of about 3.5 mg of apraglutide.

197. The method of claim 190 or 191, wherein the subject has a body weight less than 50 kg, and the pharmaceutical composition comprises an administered dose of about 1.0 mg to about 3.0 mg of apraglutide.

198. The method of claim 190 or 191, wherein the subject has a body weight less than 50 kg, and the pharmaceutical composition comprises an administered dose of about 1.0 mg to about 2.0 mg of apraglutide.

199. The method of claim 190 or 191, wherein the subject has a body weight less than 50 kg, and the pharmaceutical composition comprises an administered dose of about 1.4 mg of apraglutide.

200. The method of claim 190 or 191, wherein the subject has a body weight less than 50 kg, and the pharmaceutical composition comprises an administered dose of about 2.0 mg to about 3.0 mg of apraglutide.

201. The method of claim 190 or 191, wherein the subject has a body weight less than 50VECT-007 / 001WO (43765-02067)kg, and the pharmaceutical composition comprises an administered dose of about 2.5 mg of apraglutide.

202. The method of claim 190 or 191, wherein the subject has a body weight less than 50 kg, and the pharmaceutical composition comprises an administered dose of about 2.2 mg of apraglutide.

203. The method of any one of claims 190-202, wherein the pharmaceutical composition comprises a vial load of about 5.4 mg per vial or about 10.4 mg per vial.

204. The method of any one of claims 190-203, wherein the pharmaceutical composition comprises an apraglutide concentration from about 8.8 mg / mL to about 20.6 mg / mL.

205. The method of any one of claims 190-204, wherein the pharmaceutical composition comprises an effective added reconstitution volume from about 0.24 mL to about 1.14 mL.

206. The method of any one of claims 190-205, wherein the pharmaceutical composition comprises an injection volume from about 0.1 mL to about 0.85 mL.

207. The method of any one of claims 190-206, wherein the pharmaceutical composition is prepared by reconstituting a lyophilized powder comprising the sodium salt of apraglutide, glycine, L-histidine, and mannitol with sterile water for injection.

208. A kit comprising: a vial containing a composition according to any one of claims 69-82, 88-92, or 97-188, wherein the composition is a lyophilized powder; and a container of sterile water for injection.

209. The kit of claim 208, further comprising a first syringe for transferring sterile water into the vial to reconstitute the lyophilized powder.

210. The kit of claim 209, further comprising a second syringe for withdrawing and administering the reconstituted solution.

211. The kit of claim 210, wherein the first syringe has a capacity of about 1 mL and comprises low dead space, and the second syringe has a capacity of about 0.2 mL and comprises zero dead space.

212. The kit of any one of claims 208-211, further comprising a vial adapter configured toVECT-007 / 001WO (43765-02067)attach to the vial and pierce a septum of the vial.

213. The kit of claim 212, wherein the vial adapter comprises a female Luer-lock connection.

214. The kit of any one of claims 208-213, further comprising a needle for subcutaneous injection.

215. The kit of any one of claims 208-214, comprising supplies for administration of one dose, two doses, three doses, four doses, or more than four doses.

216. A composition of any one of Tables 1A-1, 1A-2, IB, 1C, ID, IE, IF, or 1G.

217. A composition of Table 1 A- 1.

218. A composition of Table 1 A -2.

219. A method of administering a composition of any one of claims 216-218.

220. A kit comprising: a vial containing a composition of any one of claims 216-218; and a container of sterile water for injection.

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