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Pipeline Drug: RHB-104

December 7, 2015

RedHill Biopharma announced the conclusion of the last dosing and patient follow-up visit for its Phase 2a proof-of-concept study to assess the efficacy and safety of the experimental drug RHB-104 as an add-on therapy to interferon beta-1a in patients suffering from relapsing-remitting multiple sclerosis (RRMS).

RHB-104 is an antibiotic therapy in oral capsule formulation. The trial is being conducted in Israel across two medical centers, and the 18 patients with RRMS received treatment with RHB-104 for 24 weeks and are currently being assessed for another 24 weeks.

The trial’s primary endpoint is the number of unique active lesions, assessed at baseline through week 24. Other outcome measures include the safety and tolerability of the antibiotic therapy, relapse rate, changes in cytokines, Expanded Disability Status Scale (EDSS), and the number of participants with adverse events.

Clara Fehrmann, RedHill’s director of Clinical Operations, said in the press release: “The completion of the final dosing in the active treatment phase of the Phase IIa CEASE-MS study is an important milestone in RedHill’s RHB-104 development program. Top-line interim results will become available in the coming months and we are hopeful that they will support the hypothesis that RHB-104 may counterbalance a dysregulated immune system which plays a critical role in the pathogenesis of multiple sclerosis.”

Red Hill is expected to announce top-line interim data in early 2016.