RedHill’s Experimental MS Therapy, RHB-104, Receives Notice of Allowance on U.S. Patent

RedHill Biopharma, Ltd., an Israeli biopharmaceutical company focused on the development and commercialization of oral-administered small-molecule medicines for the treatment of inflammatory and gastrointestinal diseases, recently announced it has received a Notice of Allowance from the United States Patent and Trademark Office (USPTO) for a new patent covering its product RHB-104. This drug was originally developed for the treatment of Crohn’s disease, but is now being pursued as a complementary therapy for relapsing remitting multiple sclerosis (RRMS) due to its potential anti-inflammatory and neuroprotective properties.

RHB-104 consists of an oral capsule formulation of an antibiotic combination therapy — 95 mg clarithromycin, 45 mg rifabutin, and 10 mg clofazimine — with strong intracellular, anti-mycobacterial and anti-inflammatory properties. If the U.S. patent application, titled “Compositions Comprising Rifabutin, Clarithromycin, and Clofazamine and Uses Therof,” is granted, it will cover methods of use of RHB-104 and will be valid until 2029.

Currently, RHB-104 is undergoing a Phase 3 clinical trial for the treatment of Crohn’s disease in a number of countries, including the U.S., Canada, Israel, and Australia (the MAP US study). Moreover, the drug is also undergoing a proof-of-concept, Phase 2a clinical trial that has 18 patients enrolled, with the objective to evaluate RHB-104 efficacy as an adjuvant therapy to treatment with interferon beta-1a in patients with RRMS. The CEASE-MS study, titled “Proof of Concept Study of RHB-104 as Add-On Therapy to Interferon Beta-1a in Relapsing Remitting Multiple Sclerosis,” is expected to yield its first results in the upcoming weeks.

RedHill Biopharma is also developing clinical candidate drugs to treat infection with Helicobacter pylori, acute gastroenteritis and gastritis, gastrointestinal cancers, pancreatic cancer, other solid tumors, and acute migraines. If the current patent is approved, RedHill will hold five U.S. patents for RHB-104 and other international ones.

Dr. Danielle Abramson, RedHill’s director of Intellectual Property & Research, said in a press release, “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.”