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RedHill Biopharma Announces Positive European Regulatory Meetings Regarding Its European Phase III Plan For RHB-104 (Crohn's)

Stocks in this article: RDHL

  • The Company recently held successful Scientific Advice Meetings with the UK and Swedish pharmaceutical regulatory agencies to discuss its European Phase III strategy with RHB-104 for Crohn's disease
  • The European trial will be the second Phase III study with RHB-104 and is expected to recruit an estimated 360 Crohn's patients in up to 60 sites in Europe
  • The first Phase III study with RHB-104 for Crohn's disease in North America and Israel is planned to commence within weeks

TEL-AVIV, Israel, Aug. 20, 2013 (GLOBE NEWSWIRE) -- RedHill Biopharma Ltd. (Nasdaq:RDHL) (TASE:RDHL) (the "Company" or "RedHill"), an emerging Israeli biopharmaceutical company focused primarily on the development and acquisition of late clinical-stage, proprietary formulations and combinations of existing drugs, reported that it had recently concluded Scientific Advice Meetings with the UK Medicines and Healthcare Products Regulatory Agency (MHRA) and the Swedish Medical Products Agency (MPA) regarding the regulatory path towards a Phase III clinical study in Europe with RHB-104. RHB-104 is a proprietary and potentially groundbreaking combination antibiotic therapy with potent anti-bacterial and anti-inflammatory properties, in oral pill form, targeting Crohn's disease, multiple sclerosis, rheumatoid arthritis and other unmet medical needs.

In light of the positive feedback received from the UK MHRA and the Swedish MPA, the Company believes there is a clear regulatory path towards a Phase III clinical study in Europe with RHB-104 for the treatment of Crohn's disease (the "MAP Europe" study). The Company intends to file applications to begin the Phase III MAP Europe study in several European countries and, working with a leading international CRO, has already identified potential sites for the study.

The Company plans to commence a first Phase III double-blind placebo-controlled clinical study with RHB-104 for the treatment of Crohn's disease, enrolling 240 subjects in up to 50 sites in North America and Israel (the "MAP US" study) in the coming weeks. The MAP Europe study will commence as soon as possible following the initiation of the MAP US study, in order for the two studies to be conducted in parallel. The Company also intends to complete supplemental clinical and other studies as part of the regulatory plan.

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