RedHill's RHB-204 Demonstrates Comparable MAP Killing Efficacy to RHB-104 - Important Step in RHB-204 Development for MAP-related Crohn's Disease

RHB-2041 is a next-generation optimized formulation of RedHill's oral RHB-104 2 , designed for enhanced tolerability, safety profile and patient adherence, that employs a groundbreaking Mycobacterium avium subspecies paratuberculosis (MAP)-targeted therapeutic approach for Crohn's disease (CD) In its positive Phase 3 study, RHB-104 met the primary and key secondary endpoints with statistical significance, showing RHB-104 plus standard of care (SoC) to be 64% more effective than SoC alone, in treating CD compared to the placebo (standard of care only) group (p = 0.0048) 3 New RHB-204 in vitro data, from both spot and phage assays, demonstrated comparable MAP killing to RHB-1044 . Importantly, MAP killing efficacy was achieved with lower doses of two of the active ingredients compared to RHB-104, indicative of potential for reduced toxicity and side effects Based on the FDA guidance on path to approval, RedHill's novel Phase 2 RHB-204 study is designed to be the first-ever adequately controlled clinical study in a specifically defined MAP-positive CD patient population - a potentially paradigm changing approach to treatment of Crohn's disease.