RedHill meets primary endpoint in Phase 3 Crohn’s disease study

RedHill Biopharma announced positive top-line safety and efficacy results from the first Phase III study with RHB-104 for Crohn’s disease. The study successfully met its primary endpoint and key secondary endpoints. Top-line results in the intent-to-treat population demonstrated superiority of RHB-104 over placebo in achieving remission at week 26, defined as Crohn’s Disease Active Index value of less than 150, the primary endpoint of the study. The proportion of patients meeting the primary endpoint was significantly greater in the RHB-104 group compared to placebo. The study also successfully met key secondary endpoints, demonstrating consistent benefit to Crohn’s disease patients treated with RHB-104. Patients treated with RHB-104 also achieved a statistically significant greater response at week 26 compared to placebo. Patients treated with RHB-104 also experienced a statistically significant benefit in achieving early remission defined as remission at week 16. Patients receiving RHB-104 also experienced a statistically significant benefit in durable remission over weeks 16-52, defined as continuous remission throughout the period, demonstrating an improvement of 100% over placebo1. At 52 weeks of treatment, remission in the RHB-104 arm continued to be favorable to placebo. An analysis of maintenance of remission at week 52 in subjects noted to be in remission at week 16 also demonstrated statistically significant benefit with RHB-104 over placebo. RHB-104 was found to be generally safe and well tolerated. Top-line results demonstrated that the active and placebo treatment groups experienced similarly low rates of serious adverse events and treatment emergent adverse events leading to study drug discontinuation, indicating a positive safety profile for RHB-104. The company will continue to assess additional exploratory endpoints as data becomes available, including mucosal healing, MAP status, quality of life assessment, sub-population analyses and pharmacokinetics. Additional data is expected in the comings months.

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