Oligonucleotide-based treatment for ulcerative colitis

An oligonucleotide and dinucleotide technology, used in the field of comparably used in the treatment of inflammatory bowel diseases such as active ulcerative colitis

Pending Publication Date: 2022-06-07
INDEX PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

For this reason, despite the inconvenience and discomfort of this invasive procedure, patients will tolerate medical interventions that require both colon cleansing to remove fecal matter and topical application via a spray catheter

Method used

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  • Oligonucleotide-based treatment for ulcerative colitis
  • Oligonucleotide-based treatment for ulcerative colitis
  • Oligonucleotide-based treatment for ulcerative colitis

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0177] Example 1 - Clinical Trial Study

[0178] The randomized, double-blind, placebo-controlled trial evaluated the efficacy and safety of topical cobitomod in patients with moderately to severely active ulcerative colitis according to established methods.

[0179] Methods: Men and women were selected for trials according to standard inclusion criteria in the field, including the following:

[0180] 1. Male or female ≥18 years old

[0181] 2. Diagnosed with UC, the shortest time since the diagnosis is ≥3 months

[0182] 3. Moderately to severely active left-sided UC (disease should extend 15 cm or more above the anal verge and not extend beyond the splenic flexure), as assessed by a modified Mayo score of 6 to 12 (excluding fragility of the endoscopic sub-score) Level 1) determination in which an endoscopic sub-score ≥2 as assessed by centralized interpretation of endoscopy performed at Screening Visit 1b (Day 7 to Day 10 Screening Visits) and no other individual sub-score...

reference example 1

[0246] Reference Example 1 – Clinical Trial Results Showing Optimal Dosing Frequency

[0247] In a randomized, double-blind, placebo-controlled trial, 131 patients with moderately to severely active ulcerative colitis were randomized to receive two single doses of cobitolimod / Kappaproct (30 mg) or placebo at baseline and 4 Weekly topical application during lower GI endoscopy.

[0248] Patients in the treatment and placebo groups used electronic diaries to monitor weekly maximum blood volume in their stools (none, small, or large), weekly bowel frequency (eg, <18, 18-35, 36-60, or 61+), and weekly bowel movements. Daily bowel frequency (eg, <1, 1-1.99, 2-2.99, 3-3.99, 4-4.99, 5-5.99, 6-6.99, 7-7.99, or 8+) for 12 weeks.

[0249] Results were collated and the treatment delta calculated for the treatment group relative to the placebo group. As can be seen from these results, there is a particularly high therapeutic differential 3 weeks after the initial administration.

[0250...

Embodiment 2

[0266] Example 2 - Dextran Sodium Sulfate (DSS) Induced Colitis Mouse Model

[0267] Materials and methods

[0268] Mice: Balb / c mice were purchased from Charles River Laboratories, Research Models and Services (Sulzfeld, Germany). Eight-week-old female Balb / c mice were used for the experiments and were housed in individually ventilated cages in accordance with the Animal Welfare Act. Water and food were available ad libitum.

[0269] DSS-induced colitis: 3% (w / v) Dextran Sulfate Sodium (DSS) (MP Biomedicals, Illkirch, France) was administered to the drinking water of 8 week old female Balb / c mice for 10 days. An additional control group of three mice that were completely untreated was also part of the experimental setup. Food intake and body weight were monitored on days 0, 2, 4, 6, 7, 8 and 10.

[0270] Rectal administration of cobitolmod: 40 μg, 84 μg, 1000 μg or 1560 μg of cobitolmod were administered rectally twice per mouse (on days 4 and 8). Each concentration ...

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Abstract

The present invention provides an oligonucleotide comprising the sequence 5 '-GGAACAGTTCGTCCATGGC-3' (SEQ ID NO: 2) for use in the treatment of inflammatory bowel disease in a human subject by topical administration to the colon wherein the subject has not been subjected to colon cleansing prior to said administration.

Description

technical field [0001] The present invention relates to novel therapies for the treatment of inflammatory bowel diseases such as active ulcerative colitis (UC) with oligonucleotides, especially cobitolimod. Background technique [0002] Ulcerative colitis (UC) is a disease characterized by chronic inflammation of the rectal and colonic mucosa, affecting the innermost layers in the first stage. The disease is relapsing, and active and inactive phases differ in pathology, symptoms, and treatment. The underlying etiology of UC is unknown, nor is it known what triggers the disease to recur between its inactive and active forms (Irvine, E.J. (2008) Inflamm Bowel Dis 14(4):554-565). Symptoms of active UC include progressive bloody loose stools and increased frequency of bowel movements. Active mucosal inflammation is diagnosed by endoscopy. [0003] Stools contain pus, mucus, and blood, and are often accompanied by abdominal cramps and urge to pass (tenesmi). Diarrhea may have...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/7125A61P1/00A61P1/04A61P37/04C12N15/117
CPCA61K31/7125A61P1/00A61P1/04A61P37/04C12N15/117C12N2320/35C12N2310/17C12N2310/315C12N2320/31Y02A50/30A61P29/00A61K9/0014
Inventor 彼得·泽霍尼佩尼拉·桑德瓦尔托马斯·尼特尔
Owner INDEX PHARMA
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