Israel-based biopharmaceutical company RedHill Biopharma Ltd., announced it has been issued a Notice of Allowance by the Israeli Patent Office for a new patent (No. 207420 – “Methods and Compositions for Treating Inflammatory Bowel Disease”) which covers RHB-104, a proprietary and potentially groundbreaking antibiotic combination therapy in oral capsule formulation, with potent intracellular, anti-mycobacterial and anti-inflammatory properties. The company expects the patent, once granted, to be valid until 2029.
This patent allowance in Israel expands the global reach of RedHill’s intellectual property for RHB-104, adding to existing US patents and pending applications in other territories.
RHB-104 is based on increasing evidence supporting the hypothesis that Crohn’s disease is caused by the Mycobacterium avium subspecies paratuberculosis (MAP) infection in susceptible patients. At present, RHB-104 is undergoing a multinational Phase III trial (MAP US) on patients with Crohn’s disease. A second Phase III study is set to launch in European countries and will run parallel to the ongoing MAP US study. Preliminary results of the ongoing MAP US study, which is a randomized, double-blind, placebo-controlled trial, are expected within the second half of 2016, once half of the targeting 270 patients are enrolled and have completed 26 weeks of treatment with RHB-104.
The drug is also undergoing tests as a potential treatment for relapsing-remitting multiple sclerosis (RRMS). The company recently enrolled the last patient in this open label Phase IIa, proof-of-concept clinical study that aims to evaluate RHB-104 as an adjunct therapy to interferon beta-1a in RRMS. Preliminary results are expected towards the end of 2015, or within the first quarter of 2016.
To learn more about the ongoing MAP US Phase III study, titled, “Efficacy and Safety of Anti-MAP Therapy in Adult Crohn’s Disease (MAPUS)” visit www.ClinicalTrials.gov and type in identifier number NCT01951326.
In other recent IBD news, in a new study entitled “Multimodal treatment of perianal fistulas in Crohn’s disease: seton versus anti-TNF versus advancement platy (PISA): study protocol for a randomized controlled trial,” authors present the protocol for a new, randomized multi center control trial to assess the efficacy between current three lines of therapy for Crohn’s disease patients with perianal fistulas. The study was published in the journal Trials.