Successful Phase III study (MAP US study) of RHB 104 for treatment of Crohn's disease.- RedHill Biopharma Ltd.

RedHill Biopharma Ltd. announced positive top-line safety and efficacy results from the first Phase III study with RHB 104 for Crohn�s disease (the MAP US study). The study successfully met its primary endpoint and key secondary endpoints. Top-line results in the intent-to-treat (ITT) population demonstrated superiority of RHB 104 over placebo in achieving remission at week 26, defined as Crohn�s Disease Active Index (CDAI) 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 (37% vs. 23%, p= 0.013).

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 (defined as a decrease of more than 100 in CDAI from baseline) compared to placebo (44% vs. 31%, p= 0.028). Patients treated with RHB 104 also experienced a statistically significant benefit in achieving early remission defined as remission at week 16 (42% vs. 29%, p= 0.019). Patients receiving RHB 104 also experienced a statistically significant benefit in durable remission over weeks 16-52, defined as continuous remission throughout the period, (18% vs. 9%, p= 0.038), demonstrating an improvement of 100% over placebo. At 52 weeks of treatment, remission in the RHB 104 arm continued to be favorable to placebo (27% vs. 20%, p= 0.155). 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 (25% vs. 12%, p= 0.007).

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.