RedHill Biopharma Announces Completion of Patient Enrollment in the Phase IIa Study of RHB-104 for Multiple Sclerosis

RedHill Biopharma Ltd.

("RedHill" or the "Company"), an Israeli biopharmaceutical company focused on late clinical-stage, proprietary, orally-administered, small molecule drugs for inflammatory and gastrointestinal diseases, including gastrointestinal cancers, today announced that the last patient has been enrolled in the Phase IIa, proof-of-concept clinical study evaluating RHB-104 as an add-on therapy to interferon beta-1a in patients treated for relapsing remitting multiple sclerosis (RRMS). RHB-104 is a proprietary and potentially groundbreaking antibiotic combination therapy in oral capsule formulation, with potent intracellular, anti-mycobacterial and anti-inflammatory properties. Seventeen patients were enrolled in the open label Phase IIa study (the CEASE-MS study), which is designed to assess the efficacy and safety of RHB-104 as an add-on therapy to interferon beta-1ain patients suffering from RRMS following 24 weeks of treatment. Patients are evaluated for an additional term of 24 weeks after completing treatment with RHB-104. The primary endpoint of the study is the number of combined unique active lesions after 24 weeks of treatment, as compared to baseline, and secondary endpoints include changes in cytokine levels, Mycobacterium avium subsp. paratuberculosis (MAP) status, relapse rate, Expanded Disability Status Scale (EDSS) and safety and tolerability of RHB-104. The CEASE-MS study is being conducted at two medical centers in Israel and interim results are expected either in the fourth quarter of 2015 or the first quarter of 2016. Clara Fehrmann, RedHill's Director of Clinical Operations, said: "We are very pleased to have completed patient enrollment in the Phase IIa CEASE-MS study with RHB-104. The CEASE-MS study was initiated following four successful pre-clinical studies and is based on the hypothesis that a bacterially induced dysregulated immune system plays a role in the pathogenesis of multiple sclerosis. We are hopeful that the interim results from the CEASE-MS study, expected in late 2015 or early 2016, will contribute to the understanding of the development of multiple sclerosis and will provide new treatment alternatives for patients suffering from this disease." RHB-104 is also being evaluated as a treatment for Crohn's disease and is currently undergoing a first Phase III clinical study in the U.S. and other countries (the MAP US study). Interim analysis of the MAP US study is expected in the second half of 2016. The primary endpoint is remission at week 26 of treatment. A second Phase III study with RHB-104 for Crohn's disease is planned in Europe (the MAP EU study) and clinical trial applications have been submitted.