RedHill Biopharma Ltd. Announces RHB-204 Demonstrates Comparable MAP Killing Efficacy to RHB-104

2026-04-30SEC Filing 6-K (0001178913-26-002304)

RedHill Biopharma Ltd. has announced new in vitro testing results for RHB-204, an optimized formulation of their oral drug RHB-104. The results demonstrate that RHB-204 has comparable Mycobacterium avium subspecies paratuberculosis (MAP) killing efficacy to RHB-104. Importantly, RHB-204 achieved this efficacy at lower doses of two active ingredients, suggesting a potential for reduced toxicity and side effects. RHB-204 is being developed for the treatment of Crohn's disease (CD), a condition where MAP is a suspected contributing factor. The company plans a Phase 2 study for RHB-204 in a specifically defined MAP-positive CD patient population. RHB-104 previously met its primary and key secondary endpoints in a Phase 3 study, showing a 64% improvement in efficacy compared to standard of care alone. RHB-204 is patent protected until 2041 and has received FDA Fast Track and Orphan Drug Designation, as well as QIDP Designation, with potential for extended market exclusivity. The global Crohn's disease market is substantial and projected to grow significantly. RedHill is seeking non-dilutive funding for the development of RHB-204.

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