Additional Planned and Required Studies, Which Include a Second Phase III Crohn’s Disease Trial in Europe and Other Supplementary Studies, Are Under Preparation as Part of RHB-104’s Development and Regulatory Strategy
RedHill Biopharma Ltd. RDHL 0.00% (tase:RDHL) (the “Company” or “RedHill Biopharma”), an emerging Israeli biopharmaceutical company focusing primarily on the development and acquisition of late clinical-stage, patent-protected, new formulations and combinations of existing drugs, reported today the issuance of a new U.S. patent and that a multi-site initiation process is underway in the U.S., Canada and Israel for a first multi-center, randomized, double-blind, placebo-controlled, parallel group initial Phase III study (the “MAP US Study”) to assess the efficacy and safety of fixed-dose combination RHB-104 in subjects with moderately to severely active Crohn’s disease. The MAP US Study will be conducted under an Investigational New Drug (IND) application amended in August 2012 and recruitment is planned to commence in the second quarter of 2013.
RedHill Biopharma Announces Issuance of New US Patent and Provides …
MarketWatch (press release)
In addition to the MAP US Study which is designed to provide insights into safety and efficacy of RHB-104 and initial assessment of the role of MAP in Crohn’s disease, the Company is planning and preparing for a Phase III clinical trial in Europe with …and more »