Innovation Pharmaceuticals has completed dosing of the first cohort of subjects in its Phase I trial of oral brilacidin.
The trial formally launches the company’s Ulcerative Colitis programme as it seeks to develop a treatment for Inflammatory Bowel Diseases (IBD).
Nine healthy subjects will be enrolled in the single-centre, randomised, single-blinded, placebo-controlled, single dose-escalation trial.
Each cohort will include three subjects, with two receiving brilacidin (cohort 1: 50mg, cohort 2: 100mg, and cohort 3: 200mg) and one subject administered with placebo.
Dosing of all cohorts is expected to be completed in the following weeks.
The study aims to demonstrate that brilacidin can be delivered orally and selectively to the colon. This will enable the company to treat different forms of gastrointestinal diseases, specifically Ulcerative Colitis and Crohn’s Disease.
Innovation Pharmaceuticals noted that brilacidin has shown potential in other clinical trials across multiple therapeutic areas and modes of administration.
The drug was earlier tested in a Phase II, open-label, proof-of-concept (PoC) clinical trial for Ulcerative Proctitis/Ulcerative Proctosigmoiditis (UP/UPS).
In this study, a majority of patients treated with brilacidin through retention enema achieved clinical remission (Modified Mayo scoring).
“These trial results led to the licencing of brilacidin for UP/UPS to a global pharmaceutical company,” the company added.
If the subsequent trials are equally successful, brilacidin will have significant therapeutic potentiality as an oral drug for treating IBD diseases.
Innovation Pharmaceuticals was established in 2007 to develop medicines across multiple therapy areas.
The company is headquartered in Wakefield, Massachusetts.