Innovation Pharmaceuticals has announced plans for a Phase II trial of Brilacidin in pill form as an oral medication for the treatment of ulcerative colitis (UC), an inflammatory bowel disease (IBD).
The Phase I study (NCT04240223) targeted colonic delivery of Brilacidin through the use of delayed-release formulated tablets.
Brilacidin, in its pill form, is developed as a novel, non-corticosteroid, non-biologic drug. Although it is intended for the treatment of a continuum of GI diseases, initial target indication is UC.
The new study aims to assess the efficacy and safety of oral Brilacidin in active UC across six weeks.
The efficacy endpoints of the trial include clinical remission (Mayo Scoring), endoscopic remission, biomarkers (fecal calprotectin, CRP, histologic evaluation of mucosal inflammation) and patient-reported outcomes (PROs).
IBD is said to affect approximately ten million people worldwide, including three million in the US. It is a difficult to treat, chronic, autoimmune condition. Around 70,000 newly diagnosed cases of IBD are reported each year.
The company stated that the overall GI market sector is estimated to grow from $35.7bn in 2015 to $48.4bn by 2022.
Innovation Pharmaceuticals intends to begin the trial this year and is currently consulting contract research organisations for site selection.
In January this year, the company dosed the first cohort of subjects in its Phase I trial of oral brilacidin. The study was aimed at demonstrating that Brilacidin can be delivered orally and selectively to the colon.
Founded in 2007, Innovation Pharmaceuticals develops medicines across multiple therapy areas.