RedHill Biopharma Advances its Groundbreaking Late-Stage Crohn's Disease Program Building on Statistically Significant Positive RHB-104 Phase 3 Results

Company Overview - RedHill Biopharma Ltd. is a specialty biopharmaceutical company focused on the development and commercialization of drugs for gastrointestinal diseases, infectious diseases, and oncology [12] - The company promotes the FDA-approved gastrointestinal drug Talicia® for the treatment of Helicobacter pylori infection in adults [12] Product Development - The company plans to advance its late-stage program for Crohn's disease (CD) with the initiation of a Phase 2 study of RHB-204, targeting Mycobacterium avium subspecies paratuberculosis-positive (MAP+) moderate to severe CD [1][3] - RHB-204 is a next-generation formulation of RHB-104, designed to enhance tolerability, safety, and adherence, with a 40% reduction in pill burden [2][10] - The Phase 2 study will be the first clinical trial in CD patients who are all MAP-positive, correlating mucosal healing with MAP eradication [1][3] Clinical Study Insights - The primary endpoints of the Phase 2 study will include mucosal healing, MAP status, and clinical remission, following FDA guidance [3] - Insights from the successful Phase 3 study of RHB-104 indicate that RHB-204 could be efficiently conducted with a small patient population and decisive endpoints, potentially reducing program costs [4][6] - The Phase 3 study of RHB-104 demonstrated a 64% improvement in efficacy compared to standard of care, with significant mucosal healing data [2][7] Market Potential - The Crohn's disease market is projected to grow from $13.6 billion in 2024 to over $19 billion by 2033, indicating significant commercial potential for new FDA-approved therapies [1][5] - There is a strong need for effective new therapies due to high treatment failure rates and approximately 1.6 million diagnosed cases of CD globally [6][8] Regulatory Designations - RHB-204 is patent protected until 2041 and is expected to receive pediatric orphan designation, subject to FDA approval [2][10] - The company intends to explore additional regulatory designations, such as breakthrough therapy and fast track designations, to enhance exclusivity and expedite the review process [6]