Innovation Designs Plan for Phase 2 Brilacidin Trial for Ulcerative Colitis

Innovation Designs Plan for Phase 2 Brilacidin Trial for Ulcerative Colitis
The planned brilacidin Phase 2 trial will be conducted in two parts and test several therapy doses, against a placebo, to determine the safety and effectiveness of the investigational oral ulcerative colitis (UC) medicine, Innovation Pharmaceuticals announced. The company's goal is to start the trial this summer. Brilacidin is a non-corticosteroid therapy that works on two fronts. It belongs to a class of compounds that mimic the activity of naturally occurring antimicrobial peptides, called defensins. These defensis can quickly destroy harmful microbes in the gut. Some studies have suggested that people with inflammatory bowel disease (IBD) lack defensins and this impairment contributes to the imbalance of the body’s natural barrier in the gastrointestinal tract. In addition, brilacidin has immunomodulatory properties that reduce tissue inflammation and promote wound healing. Innovation now has disclosed more information on its design plans for its upcoming Phase 2 study for UC, the treatment's initial indication. The trial will be divided in two parts, with the first segment testing multiple ascending doses — low, medium, and high — of brilacidin, and including a placebo arm, for a period of six weeks. It aims to assess the safety and tolerability of multiple doses of brilacidin, as well as to examine its exposure in patients. In the second part, the researchers will determine the therapy's efficacy in patients. During this portion of the trial, the participants will receive the multiple selected doses from the first part of the study, or a placebo. The primary efficacy points will include clinical remission, assessed with the Mayo scoring system, and endoscopic remission, which is the absence of inflammation during an endoscopy exam. Patient
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