RedHill Awaits Patent for RHB-104, Potential MS Treatment, from Japan

RedHill Biopharma recently announced that it has received a Notice of Allowance from the Japan Patent Office for a new patent covering RHB-104 as a potential treatment of multiple sclerosis (MS). Once granted, the patent will be valid until 2032.

The European Patent Office also recently approved a patent application for the drug with this indication, the company said in a press release.

RHB-104 is a novel oral capsule formulation of a therapeutic combination of antibiotics that has potent intracellular, anti-mycobacterial, and anti-inflammatory properties. The capsules consist of 95 mg of clarithromycin, 45 mg of rifabutin, and 10 mg of clofazimine. RHB-104, originally developed for the treatment of Crohn’s disease and now in a clinical trials for the condition, is also being evaluated to treat relapsing-remitting multiple sclerosis (RRMS), as its anti-inflammatory and neuroprotective properties may dampen the effects of the disease.

The Phase 2a proof-of-concept CEASE-MS (NCT01717664) trial is assessing the efficacy and safety of a fixed dose combination of RHB-104 as add-on therapy to interferon beta-1a in patients with RRMS. Participants were treated with RHB-104 plus interferon beta-1a for 24 weeks, and then assessed for an additional 24 weeks in which they received only interferon beta-1a.

RedHill announced positive interim data in March, after patients had completed the 24-week treatment period. Data showed that the treatment had beneficial safety and efficacy effects, including an encouraging relapse-free rate, and positive Expanded Disability Status Scale (EDSS) scores and MRI results. Top-line final results are expected soon.

RedHill’s patent portfolio on RHB-104, covering its oral antibiotic combination therapy, includes over 26 patents in the U.S., Canada, Japan, Australia, and many European countries, with additional patent claims being pursued.

The ongoing Phase 3 clinical trial of RHB-104 for Crohn’s disease (the MAPUS study; NCT01951326), has already enrolled more than 200 patients. Up to 410 patients are expected to take part in the trial, which is being conducted in 150 clinical sites in the U.S., Canada, New Zealand, Australia, Europe and Israel. More information on this trial, including enrollment information, is available through its clinical trials.gov webpage, or by clicking on the study’s identification number, above.

Interim data on safety analysis are expected by the end of the year.