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Innovation Pharmaceuticals Announces Dosing of First Cohort in Phase 1 Trial of Oral Brilacidin in Ulcerative Colitis Program; Topline Results Anticipated Early Q1 2020
Innovation Pharmaceuticals Announces Dosing of First Cohort in Phase 1 Trial of Oral Brilacidin in Ulcerative Colitis Program; Topline Results Anticipated Early Q1 2020.
About this update from Innovation Pharmaceuticals Inc.
[{"type":"text","content":"\n WAKEFIELD, Mass., Jan. 16, 2020 (GLOBE NEWSWIRE) -- Innovation Pharmaceuticals (OTCQB:IPIX) (“the Company”), a clinical stage pharmaceutical company, is pleased to inform shareholders that the Company has dosed the first cohort in its Phase 1 trial to investigate the use of delayed release tablets for colonic delivery of Brilacidin in healthy volunteers. This study formally launches the Company’s clinical program in Ulcerative Colitis. Assessments will include the safety, toleration, and pharmacokinetics of oral Brilacidin, and whether the drug is being dispersed directly in the colon, as assessed by gamma scintigraphy. Dosing of all cohorts in the Phase 1 trial is expected to be completed within several weeks, and topline data to follow shortly. The start of this Phase 1 trial is a major milestone for the Company, a key part of its broader clinical program in Inflammatory Bowel Diseases (IBD). The study’s primary objective is to show that Brilacidin can be delivered orally and selectively to the colon. This will enable the Company to treat more extensive forms of GI disease, primarily Ulcerative Colitis and Crohn’s Disease. Notably, in other clinical trials, Brilacidin has been shown to be a promising drug candidate in multiple therapeutic areas and across various modes of administration. In a previous Phase 2, open-label, Proof-of-Concept (PoC) clinical trial evaluating Brilacidin for Ulcerative Proctitis/Ulcerative Proctosigmoiditis (UP/UPS), a majority of patients treated with Brilacidin administered via retention enema achieved Clinical Remission (Modified Mayo scoring). Evidence of mucosal healing was supported based on endoscopic review, an increasingly important measure toward establishing a drug’s efficacy. These trial results led to the licensing of Brilacidin for UP/UPS to a global pharmaceutical company. If later trial results in the Ulcerative Colitis program are similarly as successful to those achieved in the completed UP/UPS study, the Company believes oral Brilacidin’s therapeutic potential and licensing opportunities will be significant. Big Pharma is willing to pay a premium for novel oral clinical assets in development for IBD, based on strong patient preference for easily-administered oral drugs and other economic advantages of oral delivery compared to costly and...