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Innovation Pharmaceuticals Plans for Phase 2 Trial of New Treatment for Ulcerative Colitis
Innovation Pharmaceuticals Plans for Phase 2 Trial of New Treatment for Ulcerative Colitis.
About this update from Innovation Pharmaceuticals Inc.
[{"type":"text","content":"\n Active ulcerative colitis targeted; multiple ascending dose design (low, mid, high doses and placebo)Endpoints: clinical remission (Mayo scoring); endoscopic remission; biomarkers, and others WAKEFIELD, Mass., March 05, 2020 (GLOBE NEWSWIRE) -- Innovation Pharmaceuticals (OTCQB:IPIX) (“the Company”), a clinical stage pharmaceutical company, is pleased to provide perspectives on its planned Phase 2 clinical trial of Brilacidin in pill form, its defensin mimetic drug candidate with multi-indication potential, as a novel oral medication for the treatment of Ulcerative Colitis (UC). The Company is presently interviewing Contract Research Organizations for site selection with the understanding that the goal is to initiate the trial this summer. Following the completion of a Phase 1 study (NCT04240223) that showed targeted colonic delivery of Brilacidin via the use of delayed-release formulated tablets, incorporated in the planned Phase 2 study design are elements highlighted below: To assess efficacy and safety of oral Brilacidin in active UC across 6 weeks   °  Part 1: Multiple Ascending Dose (MAD) design; low, mid, high doses and placebo       Primary Purpose: to determine multiple dose safety/toleration and exposure in UC patients        • Enriched PK collection will determine appropriate dose escalation to next cohort   °  Part 2: Parallel Design; low, mid, high doses (selected from Part 1) and placebo       Primary purpose to evaluate efficacy signal in UC patients        • Efficacy Endpoints include: Clinical remission (Mayo Scoring); Endoscopic remission; Biomarkers (fecal calprotectin, CRP, histologic evaluation of mucosal inflammation); Patient Reported Outcomes (PROs) Brilacidin is being developed in pill form as a novel, non-corticosteroid, non-biologic drug capable of treating a continuum of GI diseases, with UC the initial target indication. Alerts Sign-up for Innovation Pharmaceuticals email alerts is available at: http://www.ipharminc.com/email-alerts/ About Brilacidin for IBD Inflammatory Bowel Disease (IBD) is a hard-to-treat, chronic, autoimmune condition that affects approximately 10 million people worldwide, including 3 million people in the U.S., wi...