Innovation Pharmaceuticals has reported positive top-line results from a Phase II clinical trial of brilacidin in patients with inflammatory bowel disease (IBD) types known as ulcerative proctitis and ulcerative proctosigmoiditis (UP/UPS).
Brilacidin is a non-corticosteroid, non-biologic treatment being formulated as tablets for ulcerative colitis and Crohn’s Disease, and as foam and/or gel for UP/UPS.
The results from the open-label, proof-of-concept (PoC) trial showed that the investigational candidate achieved clinical remission in the majority of patients with mild-to-moderate UP/UPS.
The remission rates were found to be similar across all the three cohorts of the Phase II trial.
Innovation Pharmaceuticals president and chief medical officer Arthur Bertolino said: “To see such strong results with a basic formulation adds further credibility to where we believe we can take brilacidin in treating the full continuum of IBD, particularly when optimally formulated and administered.
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“Combined with the brilacidin data for treating oral mucositis as a preventative medicine, we now have two solid anchors supporting brilacidin’s considerable and diverse therapeutic potential.”
Brilacidin was evaluated as a once-daily retention enema formulation of 50mg, 100mg and 200mg over a period of 42 days, with clinical remission at day 42 as the trial's primary efficacy endpoint.
The trial’s secondary efficacy endpoints included a change in both full and partial MMDAI score and change in patient quality-of-life as measured by the short inflammatory bowel disease questionnaire (SIBDQ).
The trial demonstrated improvement in quality-of-life, as well as favourable tolerability without any serious adverse events (SAEs).
