UK Regulatory Agency Approves Launch of Innovation’s Phase 1 Trial of Brilacidin for Ulcerative Colitis

UK Regulatory Agency Approves Launch of Innovation’s Phase 1 Trial of Brilacidin for Ulcerative Colitis
The United Kingdom’s Medicines and Healthcare products Regulatory Agency has approved the launch of Innovation Pharmaceuticals’ Phase 1 trial in healthy volunteers to investigate the safety and properties of delayed-release tablets of brilacidin for the treatment of ulcerative colitis (UC). Participant screening is expected to start in the coming weeks. Brilacidin is an artificial small molecule that belongs to a new class of compounds known as defensin-mimetics. It is structurally similar to proteins naturally produced in the body that fend off bacteria and other microbes. Besides killing pathogens, the investigational therapy also lessens inflammation and promotes wound healing, while decreasing the likelihood of drug resistance. Innovation is collaborating with BDD Pharma, using the company’s proprietary OralogiK technology, to develop delayed-release brilacidin tablets that can be taken orally for targeted delivery to the colon to treat UC, a form of inflammatory bowel disease (IBD). "It’s exciting to soon start, in collaboration with our IBD formulation partner, BDD Pharma, a scientifically rigorous study of brilacidin’s potential as a novel oral IBD drug candidate," Arthur P. Bertolino, MD, PhD, former president, director, and chief medical officer of Innovation, said in a press release.  "There is a considerable market need for innovative non-corticosteroid and non-biologic IBD therapies, as which we believe brilacidin, based on its unique drug properties and characteristics, is well-positioned to emerge," Bertolino said. "A successful Phase 1 study of oral brilacidin in healthy volunteers demonstrating our ability to target drug delivery would provide additional value to our shareholders as we continue to develop brilacidin for IBD."
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