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RedHill Biopharma Ltd. Message Board

  • biotuesday biotuesday Aug 13, 2013 9:25 AM Flag

    BioTuesdays - RedHill readying Phase 3 trials in Crohn’s

    With a PDUFA target date of Feb. 3, 2014 for its migraine drug, RHB-103, and NDA filing planned for the first quarter of 2014 for the anti-emetic drug, RHB-102, RedHill Biopharma (NASDAQ,:RDHL; TASE:RDHL) is now focusing its efforts on its flagship programs: RHB-104 for Crohn’s disease and RHB-105 for Helicobacter pylori (H. pylori).

    RedHill is preparing to begin a potential groundbreaking Phase 3 study in the current quarter in North America and Israel (the MAP U.S. Study) of Crohn’s disease, using a novel patent-protected formulation that combines three antibiotic ingredients in a single capsule, and is planning and preparing a parallel Phase 3 study in Europe (the MAP Europe Study).

    “Following the discovery of the link between H. pylori bacterium and peptic ulcers, there is a growing body of evidence supporting the proposition that Crohn’s disease and other so-called autoimmune diseases, such as multiple sclerosis, are linked to infections,” chief business officer Guy Goldberg says in an interview with BioTuesdays, referring to emerging scientific evidence that the microbiome, or the trillions of intestinal microbes, plays a major role in health and disease.

    See BioTuesdays for rest of feature.......

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