Innovation Pharmaceuticals 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 burdensome IBD treatments delivered via injection and IV infusion.
In this clinical trial, nine subjects will be enrolled in the single-center, randomized, single-blinded, placebo-controlled, single dose-escalation trial, three subjects per cohort. In each cohort, two subjects will receive Brilacidin (cohort 1: 50mg; cohort 2: 100mg; and cohort 3: 200mg) and one subject will receive placebo.
The Company will keep shareholders updated as it works to complete this short Phase 1 trial.
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., with 70,000 newly diagnosed cases each year. The overall GI market sector is estimated to grow from $35.7 billion in 2015 to $48.4 billion by 2022. Brilacidin is being developed as a novel, non-corticosteroid, non-biologic treatment, with formulation plans including oral tablets for Ulcerative Colitis and Crohn’s Disease, and enema, foam and/or gel for mild-to-moderate Ulcerative Proctitis/Ulcerative Proctosigmoiditis (UP/UPS), two types of IBD. As released previously, a majority of patients treated with Brilacidin administered via retention enema achieved Clinical Remission (Modified Mayo scoring) in a Phase 2, open-label, Proof-of-Concept (PoC) clinical trial evaluating Brilacidin for UP/UPS. In addition, mucosal healing was evidenced by endoscopic review, an increasingly important measure toward establishing a drug’s efficacy.
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