RedHill Biopharma’s RHB-204 shows efficacy in Crohn’s Disease

RedHill Biopharma (RDHL) announced new in vitro testing results demonstrating RHB-204’s comparability to RHB-104 in Mycobacterium avium subspecies paratuberculosis, or MAP, killing efficacy. Oral RHB-204 is a next-generation optimized formulation of RedHill’s RHB-104, designed for enhanced tolerability, safety profile and patient adherence, that employs MAP-targeted therapeutic approach to the treatment of Crohn’s disease, or CD. Importantly, the MAP killing efficacy was achieved with lower doses of two of the active ingredients compared to RHB-104, indicative of the potential for reduced toxicity and side effects. A planned Phase 2 study of RHB-204 in CD is expected to be the first clinical study in a specifically defined MAP-positive CD patient population. RedHill is actively pursuing partnerships and collaborations for this program, in addition to non-dilutive external funding sources. The development of RHB-204 is supported by published clinical efficacy and safety data from the randomized, double-blind, placebo-controlled 331-patient Phase 3 study of RHB-104 in active CD, which successfully met its primary and secondary endpoints. The Phase 3 study also demonstrated the safety and efficacy of concomitant use of RHB-104 with anti-TNFs, immunomodulators and steroids, suggesting that RHB-204 could be a transformative safe and effective, stand-alone or combination, oral therapy.