RedHill Biopharma Receives Notice of Allowance of Fifth U.S. Patent Covering RHB-104 Phase III Crohn’s Disease Program
TEL-AVIV, Israel, Feb. 10, 2016 (GLOBE NEWSWIRE) -- RedHill Biopharma Ltd. (NASDAQ:RDHL) (TASE:RDHL) (“RedHill” or the “Company”), an Israeli biopharmaceutical company primarily focused on the development and commercialization of late clinical-stage, proprietary, orally-administered, small molecule drugs for inflammatory and gastrointestinal diseases, including cancer, today announced that it has received a Notice of Allowance from the United States Patent and Trademark Office (USPTO) for a new patent covering RHB-104.
RHB-104 is a proprietary and potentially groundbreaking antibiotic combination therapy in oral capsule formulation, with potent intracellular, anti-mycobacterial and anti-inflammatory properties, currently undergoing a first Phase III study for Crohn’s disease and a Phase IIa study for multiple sclerosis.
The patent application, entitled “Compositions Comprising Rifabutin, Clarithromycin, and Clofazamine and Uses Therof” significantly expands RedHill’s patent portfolio covering RHB-104 and is expected to be valid until 2029 once granted. Upon issuance, RedHill will hold five U.S. patents and multiple international patents for RHB-104.
Danielle Abramson, Ph.D., RedHill’s Director of Intellectual Property & Research said: “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 currently undergoing a first Phase III study for Crohn’s disease in the U.S., Canada, Israel, Australia and additional countries (the MAP US study). A second Phase III study (the MAP EU study) is planned to be conducted in select European countries in parallel with the ongoing MAP US study. Interim analysis of the ongoing randomized, double-blind, placebo-controlled MAP US study is expected in the second half of 2016, after half of the 270 patients planned to be enrolled in the study will have completed 26 weeks of treatment.
RHB-104 is also being evaluated as a treatment for relapsing-remitting multiple sclerosis (RRMS). The open label Phase IIa, proof-of-concept clinical study is evaluating RHB-104 as an add-on therapy to interferon beta-1a in patients treated for RRMS (the CEASE-MS study). Top-line interim results are expected in the coming weeks.
The MAP US Phase III study and the CEASE-MS Phase IIa study are registered on www.ClinicalTrials.gov, a web-based service of the U.S. National Institutes of Health, which provides access to information on publicly and privately supported clinical studies.
About RedHill Biopharma Ltd.:
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Company contact: Adi Frish Senior VP Business Development & Licensing RedHill Biopharma +972-54-6543-112 firstname.lastname@example.org IR contact (U.S.): Marcy Nanus Senior Vice President The Trout Group +1-646-378-2927 Mnanus@troutgroup.com