Date: 31-Dec-2019

Innovation Pharma to begin patient screening for phase 1 trial of oral brilacidin to treat ulcerative colitis

Innovation Pharmaceuticals, a clinical stage pharmaceutical company, announced that patient screening for its phase 1 trial to investigate the use in healthy volunteers of delayed release tablets for colonic delivery of oral Brilacidin for treating ulcerative colitis, a chronic form of inflammatory bowel disease (IBD), is expected to commence in early January. Approximately two weeks ago, the United Kingdom’s Medicines and Healthcare products Regulatory Agency granted the Company approval to start the phase 1 trial. Along with assessing the safety, toleration, and pharmacokinetics of oral Brilacidin, the study will evaluate the delivery of oral Brilacidin directly to the colon by utilising advanced delayed-release drug delivery technology developed by the Company’s formulation partner. “The study is expected to be a quick one, with dosing completed within several weeks of commencement, and, if successful, would translate into numerous potential positive outcomes for the company,” noted Leo Ehrlich, chief executive officer at Innovation Pharmaceuticals. “We are optimistic about the safety and efficacy profile of Brilacidin in IBD based on our prior clinical trial in ulcerative proctitis/ulcerative proctosigmoiditis, and are further encouraged that our out-licensing partner in this indication is planning to start trials mid-year 2020. Now the key to differentiation and really catching the attention of big pharma for the opportunity is efficient delivery of the drug directly into the colon.” Ehrlich continued: “Given the industry buzz around the recent IPOs of Galera Therapeutics and Monopar Therapeutics, each with late-stage drug candidates targeting Oral Mucositis, we feel confident about the competitive positioning and commercial prospects of oral rinse Brilacidin as a preventative OM drug candidate and the considerable value it can bring to our company. The investment community seems to be waking up to the large unmet need in this area. We anticipate an active partnering process, with meetings scheduled with pharmaceutical companies interested in Brilacidin-OM during the 2020 J.P. Morgan Healthcare conference this January in San Francisco. A licensing deal for the Brilacidin-OM asset would bring significant upside for our shareholders.” In other news: The Company would like to inform shareholders that Arthur P. Bertolino, MD, PhD, MBA, has resigned from his positions as director, and president and chief medical officer. Dr. Bertolino and the company have discussed the possibility for Dr. Bertolino continuing to serve as a consultant to the Company. The Company will begin interviewing new candidates for the position of chief medical officer in January.