Oral Multiple Sclerosis Drug Completes Phase 2 Trial

A proof-of-concept phase 2a study of a fixed oral dose RHB-104 for relapsed-remitted multiple sclerosis (RRMS) was recently completed, with results expected to be released later this year.

The open-label CEASE-MS enrolled 18 patients with RRMS to evaluate the safety and potential efficacy of RHB-104 as an add-on therapy to interferon beta-1a. RHB-104 is a proprietary, and potentially groundbreaking, oral antibiotic combination therapy, with potent intracellular, anti-mycobacterial and anti-inflammatory properties.

During the study, participants were given RHB-104 for 24 weeks, and were evaluated for an additional 24-week follow-up period where they received interferon beta-1a without the RHB-104 add-on. The study analysis is currently ongoing, and the top-line final results are expected to be announced in the fourth quarter of 2016, subject to completion of review requirements and of the clinical study report.

Back in March 2016, RedHill Biopharma announced top-line interim results after completion of the 24-week RHB-104 treatment period, which demonstrated positive safety and efficacy signals that further support clinical development. The top-line interim results demonstrated an annualized relapse rate at 24-weeks of 0.288 in the modified intent-to-treat (mITT) population, and 0.0 in the per-protocol (pp) population, which compared favorably with previously reported pivotal studies of interferon beta-1a therapies Avonex (0.67) and Rebif (0.87-091).

The study showed that 88% of the mITT patients and 100% of the PP patients were relapse free at 24 weeks, which compared favorably with previously reported pivotal data on the use of Rebif (75%) in comparison with Avonex (63%) as standalone first-line therapies. None of the participants relapsed after week 8 of treatment.

Currently, RHB-104 is undergoing a phase 3 trial for Crohn’s disease in the United States, Canada, Europe, Australia, and Israel.