RedHill Biopharma’s RHB-104 shows positive Phase 3 results in Crohn’s Disease

RedHill Biopharma announced the new publication of ground-breaking positive data showing that triple antimicrobial therapy with RHB-104 plus standard of care, targeting Mycobacterium avium subspecies paratuberculosis, is 64% more effective than SoC alone in Crohn’s disease, supporting the hypothesis of a Mycobacterial basis to the disease. The data from the Phase 3 study of anti-mycobacterial therapy in active Crohn’s disease was published in the peer-reviewed journal Antibiotics. Data for the primary endpoint, clinical remission at week 26, shows, with high statistical significance, that 36.7% – 61/166 – of RHB-104 patients achieved clinical remission at week 26 vs. 22.4% of placebo patients. RHB-104 was found to be generally safe and well tolerated, with adverse event reporting similar to placebo.