Phase III MAP US study of RHB 104 meets endpoint in Crohn�s disease.-RedHill Biopharma

RedHill Biopharma announced full Week 52 results for all subjects in the previously announced positive Phase III randomized, controlled study of RHB 104 (rifabutin + clarithromycin + clofazimine) in Crohn�s disease (the �MAP US study�) and supportive top-line results from the open-label extension Phase III study (the �MAP US2 study�). The full Week 52 results of blinded treatment in the MAP US Phase III study with RHB-104 were consistent with the previously reported positive outcomes of the study. The study continued to meet its primary endpoint of clinical remission (CDAI less than 150) at week 26 (36.7% vs. 22.4%, p=0.0048), key secondary endpoints of maintenance of remission at weeks 16 and 52 (25.9% vs. 12.1%, p=0.0016) and, notably, durable clinical remission on all visits, week 16 through 52 (18.7% vs. 8.5%, p=0.0077, RHB-104 vs. placebo, respectively).

In the analysis of the complete safety information for the study, a top-line electrocardiogram (ECG) monitoring report for the MAP US study recently received and shared with FDA, demonstrated evidence of progressive prolongation of the QTcF interval across visits, with the largest placebo-corrected delatQTcF (deltadeltaQTcF) of 30.6 ms at Week 52 of treatment with RHB-104. None of these QT abnormalities resulted in adverse cardiac events. Clofazimine, as well as clarithromycin (another active component of RHB-104), are known to be associated with QT prolongation. RedHill continues to analyze the data from the RHB-104 studies, including QT prolongation findings and various pharmacokinetic and pharmacodynamic models and, as previously announced, intends to meet with the FDA again in the coming months to discuss the RHB-104 program, including these data.

The MAP US2 open-label extension Phase III study evaluated the safety and efficacy of RHB-104 in subjects from the MAP US study with persistent active Crohn�s disease (Crohn�s Disease Active Index (CDAI) at least 150) after 26 weeks of blinded study therapy. A total of 54 subjects entered the open-label extension study and 30 subjects completed 52 weeks of treatment. Interim top-line results from the MAP US2 study demonstrated 27.8% clinical remission with RHB-104 at week 16 and 22.2% remission at week 521. Of the MAP US2 subjects who were previously randomized to the placebo arm (as an add-on to standard-of-care therapies) in the MAP US study and treated with RHB-104 for the first time in the MAP US2 study, 31.6% achieved remission at week 16 and 26.3% achieved remission at week 52. These results further support the potential clinical benefit of treatment with RHB-104 in Crohn�s disease patients. RHB-104 was found to be generally safe and well tolerated.