Positive Interim Trial Results of Brilacidin for IBD Announced by Cellceutix

Positive Interim Trial Results of Brilacidin for IBD Announced by Cellceutix
Cellceutix announced additional interim positive findings from its ongoing Phase 2a trial evaluating brilacidin (PMX-30063) as a treatment for two types of inflammatory bowel disease (IBD) – ulcerative proctitis and ulcerative proctosigmoiditis (UP/UPS). The proof-of-concept, open-label, dose-escalation trial is designed to evaluate the effectiveness, safety and drug properties of three dosing regimens of brilacidin – 50 mg (cohort A), 100 mg (cohort B), and 200 mg (cohort C) – in patients with active mild to moderate UP/UPS. Three of six patients in the third and final group (cohort C) of the study were enrolled earlier this week and the company anticipates the full study will be completed by the second quarter of 2017, just in time to present it at the 2017 Drug Discovery and Therapy World Congress July 10-13 in Boston. Confirming the results in a previous announcement, all 12 patients in two groups completed treatment with brilacidin and all demonstrated a good response to treatment. The study also met its primary effectiveness endpoint in six patients (three in each group), meaning that at day 42, these patients were in clinical remission. Two others were in partial remission and the remaining four did not meet remission criteria. Notable improvements were observed in 10 of 11 patients (one patient declined endoscopy at the end of treatment): 100% reduction in two patients in cohort A and two patients in cohort B; 50% to 75% reduction in two patients in cohort A and four patients in cohort B; and 20% reduction in one patient in cohort A. Data from the first two cohorts had also shown that the drug was well-tolerated, with no measurable systemic absorption detected. Brilacidin is a small synthetic molecule that is designed to kill pathog
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