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An Update on MS Pipeline Drug RHB-104

April 13, 2016

We last heard from RedHill Biopharma back in December, as they announced the conclusion of the last dosing and patient follow-up for its Phase 2a proof-of-concept study to assess the safety of its experimental drug RHB-104. This drug was meant to be an add-on to RRMS patients taking interferon beta-1a.

RedHill has announced promising interim results from that ongoing clinical trial. Annualized relapse rate at 24 weeks was 0.288 in the modified intent-to-treat population, and 0.0 in the per-protocol population. These results compare favorably with previously reported data of interferon beta-1a therapies Avonex and Rebif.

Results also indicated a reduction in MRI T2 lesion volume, a definition of burden of disease and indicator of response and progression in RRMS, at 24 weeks of treatment with RHB-104 as compared to baseline. Such results again compared favorably to previous data for Avonex and Rebif treatment. Importantly, RHB-104 was found to be safe and well-tolerated, and no drug-related serious side-effects were observed.

“We are very pleased with the interim results from the ongoing CEASE-MS Phase IIa proof-of-concept study with RHB-104 for relapsing-remitting multiple sclerosis (RRMS). The initial findings from the study, including safety, clinical and MRI, support the therapeutic potential of RHB-104 as add-on therapy in RRMS,” said Dr. Ira Kalfus, MD, medical director of RedHill and for the CEASE-MS study. “Although designed as an exploratory proof-of-concept study in a very small patient population and not powered for efficacy, the study interim results demonstrate positive safety data and clinical signals, supporting additional studies to better investigate the therapeutic potential of RHB-104 in RRMS.”