Cellceutix’s IBD Therapy Brilacidin Progresses to Highest Dose Group in Phase 2 Trial

Cellceutix’s IBD Therapy Brilacidin Progresses to Highest Dose Group in Phase 2 Trial
Cellceutix says the ongoing Phase 2 clinical trial of its lead drug candidate Brilacidin has progressed to its third cohort (highest dose) to induce remission of mild-to-moderate ulcerative colitis, now that the study's Safety Committee has reported satisfactory safety results with prior cohorts. In January, the Massachusetts company announced that it had completed enrollment of the second cohort of its Phase 2 open label Proof-of-Concept (PoC) trial evaluating Brilacidin as a novel treatment for mild-to-moderate ulcerative proctitis (UP) and ulcerative proctosigmoiditis (UPS), two variants of inflammatory bowel disease (IBD). Both mucosal inflammatory diseases of unknown cause, UP involves only the rectum, while UPS affects both the rectum and the distal colon. Researchers evenly divided the PoC trial's 18 patient participants into three cohorts, with Cohort A receiving 50 milligrams (mg) of Brilacidin once daily administered by rectum as a retention enema for 42 days. Dosing for Cohort B and Cohort C increases to 100 mg and 200 mg once daily for 42 days, respectively. After 42 days, doctors perform endoscopic evaluations of the rectum and mucosa. The Safety Committee reviews safety and retention data such as clinical laboratory findings, vital signs, adverse events and retention times after 21 days of therapy for all six patients in each cohort before enrolling the subsequent cohort. Initial data from the first cohort showed the drug to be well-tolerated, with no measurable systemic absorption detected. The second cohort continued to tolerate the treatment well, their comments echoing those of patients in Cohort A, regarding improved quality of life. Researchers are now analyzing efficacy data and planning to enroll participants for Cohort C.
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