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.
“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).