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.

“To date, the trial has exceeded our expectations on all fronts,” said Arthur P. Bertolino, MD, PhD, MBA, the company’s president and chief medical officer. “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. Given Brilacidin’s unique mechanism of action, the body is able to get back to doing what it’s usually already good at — fighting illness and infection.”

Gastroenterological studies of Brilacidin administered in both foam and tablet formulations are planned, and expected to improve patient convenience and study outcomes. Additional trials of Brilacidin are also being designed to evaluate its effectiveness in treating hidradenitis suppurativa and atopic dermatitis (eczema).

Brilacidin, modeled after the Host Defense Proteins (HDPs) — the immune system’s front line of defense — is a small synthetic molecule that kills pathogens rapidly, significantly reducing the likelihood of drug resistance. Brilacidin also has robust immunomodulatory capacity, which helps mitigate inflammation and promotes healing.

Because it is a new antibiotic, representing the first in a new class of anti-infectives, Cellceutix’s evaluation of Brilacidin is being conducted under a Qualified Infectious Disease Product designation. This qualifies Brilacidin for the U.S. Food and Drug Administration’s Fast Track and Priority Review, as well as an extra five years of market exclusivity upon approval.


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