Business
Innovation Pharmaceuticals Phase 1 Trial of Brilacidin for Ulcerative Colitis Meets Primary Endpoints; Positive Topline Results of Oral Brilacidin
Innovation Pharmaceuticals Phase 1 Trial of Brilacidin for Ulcerative Colitis Meets Primary Endpoints; Positive Topline Results of Oral Brilacidin.
About this update from Innovation Pharmaceuticals Inc.
[{"type":"text","content":"\n Targeted colonic delivery shownDrug well-tolerated WAKEFIELD, Mass., Feb. 13, 2020 (GLOBE NEWSWIRE) -- Innovation Pharmaceuticals (OTCQB:IPIX) (“the Company”), a clinical stage pharmaceutical company, is pleased to announce that preliminary top-line data from its Phase 1 trial (NCT03234465) studying the use of delayed-release tablets of Brilacidin showed the trial met its primary endpoints. In the study, the timed-release OralogiK™ formulation of Brilacidin was radiolabeled (with complexed technetium-99m) and evaluated for safety and colonic delivery in 9 healthy volunteers (6 with Brilacidin and 3 placebo) as part of the Company’s larger clinical development program in Inflammatory Bowel Disease (IBD). Study results show that Brilacidin delayed-release tablets were well tolerated across all treatment cohorts with no serious adverse events reported. Of the 9 subjects treated, 2 subjects on Brilacidin and 2 subjects on placebo experienced at least one adverse event. The adverse events were of mild intensity and none were deemed to be related to study treatment. Gamma scintigraphic imaging was used to visualize in vivo performance of the enteric coated delayed release tablets designed to target delivery of Brilacidin (50mg, 100mg, and 200mg) to the colon. For Brilacidin treatments, radiolabel release was observed in the ascending colon for four out of the six subjects and in the terminal ileum and ileocecal junction for the remaining two. Following release, dispersion of the radiolabel was then observed throughout the colon.  Serial blood samples were collected through 24 hours post-dose to assess absorption of oral Brilacidin from the colon. Blood level analysis, using a sensitive limit of quantitation in plasma of 1 ng/mL, demonstrated no quantifiable Brilacidin concentrations at any timepoint across treatment cohorts and shows containment of Brilacidin within the target location. (Confirmatory repeat plasma concentration analyses are ongoing to verify this finding). Given Brilacidin has shown clinical efficacy with limited absorption in other clinical trials, in Ulcerative Proctitis/Ulcerative Proctosigmoiditis and Oral Mucositis, these results suggest oral Brilacidin for IBD might be safely dosed at even higher levels of drug via targeted release tablet. Professor Howard Stevens, ...