BEVERLY, MA – October 3, 2019 (GLOBE NEWSWIRE) Innovation Pharmaceuticals (OTCQB:IPIX) (“the Company”), a clinical stage biopharmaceutical company, is pleased to inform shareholders that management is finalizing documentation necessary to initiate the planned Phase 1 clinical trial of oral Brilacidin in its Ulcerative Colitis (UC) program. Document submissions are expected to be completed early in October, keeping the clinical trial on track for commencement in December.
The study evaluating Brilacidin in tablet form in healthy volunteers will be the first in a series of clinical trials, effectively launching the Company’s UC clinical program in the anchored Brilacidin franchise. Assessments will include the safety, toleration, pharmacokinetics of Brilacidin, and whether it is being dispersed directly in the colon. An expedient clinical trial, dosing of all cohorts is expected to be completed within three weeks of commencement. Top-line data are anticipated within 2-3 months, thereafter.
“Brilacidin has already met positive efficacy endpoints in various indications, delivered via different modes of administration, including intravenously, as an oral rinse and as a retention enema—thereby greatly enhancing the treatment potential of this novel defensin-mimetic compound. In collaboration with our oral formulation partner, BDD Pharma, we will be testing Brilacidin in a tablet version for the first time, which is a significant milestone for us as it is the preferred method of drug delivery for the UC indication,” commented Arthur P. Bertolino, MD, PhD, MBA, President and Chief Medical Officer at Innovation Pharmaceuticals. “We’re targeting a lucrative market in Ulcerative Colitis where a new oral medication would command tremendous value. We feel confident in the tablet formulation of Brilacidin treating the broader disease of UC by selective delivery to the colon. This further complements our recent partnering of Brilacidin in Ulcerative Proctitis/Proctosigmoiditis with Italy’s Alfasigma. We look forward to providing more details on the planned Phase 1 trial of oral Brilacidin in the near future.”