Cellceutix Enrolls Second Group in Phase 2 Trial of IBD Therapy Brilacidin

Cellceutix Enrolls Second Group in Phase 2 Trial of IBD Therapy Brilacidin
Cellceutix has completed enrolling a second cohort of patients with mild-to-moderate ulcerative proctitis/ulcerative proctosigmoiditis (UP/UPS), two forms of inflammatory bowel disease (IBD), in its Phase 2 clinical trial evaluating brilacidin (PMX-30063). Treatment of this group is expected to be complete by the end of February. The open-label, proof-of-concept Phase 2 clinical trial is designed to assess the remission of the condition (its primary endpoint) in 18 adult patients with mild-to-moderate UP/UPS. The trial is composed of three cohorts (six patients per group), with progressive dose escalation by cohort — 50 mg, 100 mg, and 200 mg of brilacidin, respectively. Patients are receiving brilacidin through retention enema once daily at bedtime for six weeks. Review of safety data from the first cohort revealed that treatment with brilacidin 50 mg once daily was well-tolerated with no measurable systemic absorption detected. These tolerability results allowed the approval of dose escalation of 100 mg once daily to the second group of patients. The first group of treated patients also showed clinically meaningful improvements in symptoms of UP/UPS, as measured by patient reported outcomes and physician assessments, further supported with endoscopic evaluation of disease activity. “To date, the trial has exceeded our expectations on all fronts. The study needs to be successfully completed with the final data fully analyzed, but at this point we attribute the early favorable results to brilacidin’s robust anti-inflammatory therapeutic profile," Arthur P. Bertolino, MD, president and chief medical officer at Cellceutix, said in a
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