RedHill Biopharma recently announced that it received a Notice of Allowance from the United States Patent and Trademark Office (USPTO) for its patent covering RHB-104, a new oral combination drug currently being assessed in clinical trials for Crohn’s disease treatment.
RedHill is an Israeli biopharmaceutical company focusing on the development of orally administered drugs for inflammatory and gastrointestinal diseases, such as Crohn’s. RHB-104, is composed of three antibiotics, rifabutin, clarithromycin, and clofazamine. According to RedHill, the drug has potent intracellular, anti-mycobacterial and anti-inflammatory properties, and is currently in a Phase 3 trial as a Crohn’s treatment. The drug builds on evidence that infection with the bacterial subspecies Mycobacterium avium paratuberculosis (MAP) causes Crohn’s disease in susceptible patients.
MAP most commonly infects dairy cows and non-human primates, but appears to have also spread to humans. None of the antibiotics included in the preparation are new, and as separate drugs, they have been on the market for a couple of decades. The patent, however, applies to the combination preparation, as an oral capsule, and its use. If granted, the patent is expected to be valid until 2029.
The MAP U.S. study is a Phase 3 clinical trial investigating RHB-104 for Crohn’s disease in the U.S., Canada, Australia and several other countries. A second Phase 3 trial — the MAP EU study — is in the planning stage and will be conducted in a number of European countries simultaneously with the MAP U.S. study. Interim analysis of the MAP U.S. trial is expected toward the end of 2016, when half of the patients have completed 26 weeks of treatment. The study plans to enroll 270 patients.
In a press release, Danielle Abramson, RedHill’s director of Intellectual Property & Research, concluded, “We are very pleased to announce this new addition to RedHill’s already robust patent portfolio covering RHB-104. The Phase III study with RHB-104 for Crohn’s disease, currently ongoing in the U.S. and additional countries, is advancing well, with interim analysis expected in the second half of 2016.”
RHB-104 is also currently being evaluated as an add-on treatment in patients with multiple sclerosis in a Phase 2a proof-of-concept study.
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