Modified factor VII polypeptides for subcutaneous administration and on-demand treatment

A technology for subcutaneous administration of factors, applied in the direction of anticoagulant factors immunoglobulin, peptides, peptidases, etc., can solve the problem of lack of treatment options

Pending Publication Date: 2022-07-08
GC生物制药公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Patients with hemophilia and other bleeding disorders, including hemophilia A or hemophilia B with or without inhibitors, lack rapid and easy treatment options for acute bleeding

Method used

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  • Modified factor VII polypeptides for subcutaneous administration and on-demand treatment
  • Modified factor VII polypeptides for subcutaneous administration and on-demand treatment
  • Modified factor VII polypeptides for subcutaneous administration and on-demand treatment

Examples

Experimental program
Comparison scheme
Effect test

Embodiment I-1

[0191] Embodiment 1-1. A method of treating a bleeding event in a subject comprising subcutaneously administering a dose of Modified Factor VIIa (FVIIa), wherein:

[0192] The modified FVIIa has greater activity or potency than FVIIa, FVIIa is unmodified and the amino acid sequence is set forth in SEQ ID NO: 3; and

[0193] A dose of modified FVIIa is administered subcutaneously within about 5 or 4 or 3 or 2 or 1 or less hours or minutes before and / or after a bleeding event to reduce or stop the amount of bleeding or to correct or cure the cause of the bleeding.

Embodiment I-2

[0194] Embodiment 1-2. The method of embodiment 1-1, wherein the subcutaneous dose of modified FVIIa is administered subcutaneously every 3-7, 2-5, 4-6 or 4-12 hours until bleeding ceases or causes Corrected, or any wound healed or persisted for 1 to 2, 3, 4 or 5 days.

Embodiment I-3

[0195] Embodiment 1-3. The method of embodiment 1-1 or 1-2, wherein the dose of modified FVIIa is per 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11 or 12 hours.

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Abstract

Provided herein are modified FVII polypeptides and modified FVIIa polypeptides, as well as methods of treating acute and intermittent bleeding with modified Factor VIIa polypeptides. To achieve treatment and use, in some embodiments, the modified polypeptides are administered subcutaneously to provide on-demand treatment. In some embodiments, the on-demand treatment is provided in a multiple dosing regimen over a period of 24 hours. Subcutaneous administration of the modified polypeptides of the invention exhibits increased blood coagulation activity, potency, bioavailability and extended duration.

Description

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS [0002] This application claims US Provisional Patent Application No. 63 / 010,656, filed on April 15, 2020, and US Provisional Patent Application No. 62 / 970,152, filed on February 4, 2020, filed on August 15, 2019 Priority of US Provisional Patent Application No. 62 / 887,599, US Non-Provisional Patent Application No. 16 / 994,573, filed Aug. 15, 2020, and International Application No. PCT / US2020 / 046577, filed Aug. 15, 2020 , each of which is incorporated herein by reference in its entirety. [0003] Sequence Listing Reference [0004] An electronic version of the Sequence Listing is hereby submitted, the contents of which are incorporated by reference in their entirety. An electronic archive was created on August 14, 2020, 1.23 megabytes in size, and titled CTBI_003_03TW_SeqList_ST25.txt. Background technique [0005] The coagulation cascade pathway is a proteolytic pathway in which each enzyme is present in plasma as a zymogen...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K38/48A61K39/395A61P7/04C12N9/64A61K31/7105
CPCA61K38/4846A61K39/3955A61K31/7105A61K9/0019A61P7/04C12N9/6437C12Y304/21021A61K2300/00A61K2039/505C07K16/36C07K2317/24C07K2317/31C12N15/113C12N2310/14C12N2320/31
Inventor G·E·布劳斯T·努森H·莱维
Owner GC生物制药公司
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