RedHill Biopharma to continue MAP US phase III study with RHB-104 for Crohn's disease.
M2 EQUITYBITES-December 15, 2016-RedHill Biopharma to continue MAP US phase III study with RHB-104 for Crohn's disease
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The independent Data and Safety Monitoring Board (DSMB) has granted a unanimous recommendation to RedHill Biopharma (NASDAQ / TASE: RDHL), an emerging biopharmaceutical company, to continue the MAP US phase III study with RHB-104 for Crohn's disease, as proposed, without any changes, it was reported yesterday.
The decision follows a pre-planned review of safety data. The product is an antibiotic combination therapy in oral capsule formulation, with potent intracellular, anti-mycobacterial and anti-inflammatory properties. It has been developed on the evidence supporting the theory that Crohn's Disease, and potentially other autoimmune diseases and Mycobacterium avium subspecies paratuberculosis infection are related to each other in susceptible patients.
The phase three study of the product will be a randomised, double-blind, placebo-controlled trial in patients having moderate to severely-active Chron's disease. Around 242 patients have so far been enrolled out of 410 who will be participating in different locations in the US, Canada, Israel, Europe, Australia and New Zealand.
RedHill Biopharma said that it would carry out additional studies before it files a New Drug Application (NDA) in the US for RHB-104.
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|Publication:||M2 EquityBites (EQB)|
|Date:||Dec 15, 2016|
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