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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 2020WAKEFIELD, 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 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. About rilacidin for IBD Alerts About Innovation Pharmaceuticals Forward-Looking Statements: This press release contains forward-looking statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 including statements concerning the future execution of a definitive agreement with a global pharmaceutical company and the anticipated terms thereof, our future drug development plans, other statements regarding future product developments, and markets, including with respect to specific indications, and any other statements which are other than statements of historical fact. These statements involve risks, uncertainties and assumptions that could cause the Company’s actual results and experience to differ materially from anticipated results and expectations expressed in these forward-looking statements. The Company has in some cases identified forward-looking statements by using words such as “anticipates,” “believes,” “hopes,” “estimates,” “looks,” “expects,” “plans,” “intends,” “goal,” “potential,” “may,” “suggest,” and similar expressions. Among other factors that could cause actual results to differ materially from those expressed in forward-looking statements are the Company’s need for, and the availability of, substantial capital in the future to fund its operations and research and development; including the amount and timing of the sale of shares of common stock under securities purchase agreements; the fact that the Company’s licensee(s) may not successfully complete pre-clinical or clinical testing and the Company will not receive milestone payments, or the fact that the Company’s compounds may not successfully complete pre-clinical or clinical testing, or be granted regulatory approval to be sold and marketed in the United States or elsewhere. A more complete description of these risk factors is included in the Company’s filings with the Securities and Exchange Commission. You should not place undue reliance on any forward-looking statements. The Company undertakes no obligation to release publicly the results of any revisions to any such forward-looking statements that may be made to reflect events or circumstances after the date of this press release or to reflect the occurrence of unanticipated events, except as required by applicable law or regulation. INVESTOR AND MEDIA CONTACT |