Innovation Pharmaceuticals announced plans to initiate in 2019 a clinical trial of Brilacidin, its novel defensin-mimetic drug candidate, as an oral dosage form. Building upon the successful Phase 2 Proof-of-Concept (PoC) clinical trial for Ulcerative Proctitis/Ulcerative Proctosigmoiditis (UP/UPS), the aim of this program is to develop treatment for the more extensive forms of Inflammatory Bowel Disease (IBD), such as Ulcerative Colitis and Crohn’s Disease. In the Phase 2 PoC trial, Brilacidin administered as a retention enema for treating UP/UPS demonstrated a clinically meaningful improvement with more than 50% of patients experiencing clinical remission of disease at day 42. Additional clinical measures supported the therapeutic benefit of Brilacidin, including rectal bleeding eliminated in 16 of 17 patients at day 42 and 16 of 17 patients reporting improved quality of life per Short IBD Questionnaire. Furthermore, Brilacidin showed a favorable safety profile with no serious adverse events reported and the therapy well-tolerated by patients. The planned oral Brilacidin clinical trial builds on recently released data showing in simulated gastric fluid testing very minimal degradation of Brilacidin across 4 hours, suggesting Brilacidin likely would not be subject to rapid breakdown once in the stomach. These, and other data, are informing necessary manufacturing next steps including soliciting Requests-for-Proposals from vendors toward developing an elegant, tailored oral dosage form of Brilacidin. As a first step, a simple oral formulation of Brilacidin, may be expediently tested in human volunteers, while the refined oral dosage form of Brilacidin is developed in parallel. The anticipated clinical study’s primary goals include assessing safety and toleration, pharmacokinetics, and the effects of Brilacidin on the gut’s microbiome.