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 f
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2 comments

  1. mike wildt says:

    Results of this trial, combined with results from an ongoing phase 2 Brilacidin trial for oral mucositis in head and neck cancer patients and a completed phase 2B trial for ABSSSI that proved results comparable to daptomycin and it shows why many are excited about the possibilities of Brilacidin.
    Cellceutix also has a current phase 2B trials well underway with their psoriasis candidate drug Prurisol and their cancer drug Kevetrin.

    http://www.cellceutix.com/
    https://clinicaltrials.gov/ct2/results?term=cellceutix&Search=Search

    • mike wildt says:

      The oral mucositis trial is being conducted in Europe currently, and doesn’t show up on clinicaltrials.gov. We are awaiting interim results presently. Initial observations were very positive.

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