Oral Brilacidin Found to be Well-tolerated in Healthy Volunteers With Delivery Localized to the Colon, Trial Shows

Oral Brilacidin Found to be Well-tolerated in Healthy Volunteers With Delivery Localized to the Colon, Trial Shows
Delayed-release oral tablets of brilacidin for ulcerative colitis (UC) was found delivered and dispersed into the colon, and was well-tolerated in healthy volunteers in a Phase 1 trial, announced the treatment's developer, Innovation Pharmaceuticals. Brilacidin is a small molecule that belongs to a new class of compounds known as defensin-mimetics. It mimics antimicrobial peptides (small proteins) that are naturally produced in the body and serve as the “front-line” defence, or innate immune system, against harmful microbes. For this reason, brilacidin can kill microbes quickly, decreasing the likelihood of drug resistance, and also has immunomodulatory properties that lessen inflammation and promote wound healing. Of note, some studies have suggested that patients with inflammatory bowel disease (IBD) are deficient in antimicrobial peptides called defensins and other proteins called mucins, which are important for the body's natural barrier in the gastrointestinal tract. Therefore, brilacidin is thought to potentially compensate for this deficiency. The Phase 1 trial (NCT04240223), launched in January this year, enrolled nine healthy volunteers, six of whom received brilacidin and three took a placebo. Participants were divided into three dosing groups, within which two participants received one of three doses of brilacidin (50 mg, 100 mg, or 200 mg), and one subject received a placebo. The study was the first to test delayed-release tablets of brilacidin for colonic delivery — a formulation based on BDD Pharma's OralogiK technology — in collaboration with Innovation. In addition to assessing brilacidin’s safety, tolerability, and pharmacokinetic properties (the availability and elimination of the therapy from the body), the investigators t
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