IRVING, Texas, July 10, 2018 (GLOBE NEWSWIRE) -- Reata Pharmaceuticals, Inc. (Nasdaq:RETA), a clinical-stage biopharmaceutical company, today announced that the European Commission has granted orphan drug designation for omaveloxolone for the treatment of Friedreich’s ataxia (FA), based on the positive opinion from the Committee for Orphan Medicinal Products of the European Medicines Agency (EMA).
Last year, Reata reported results from part 1 of MOXIe, a two-part, international, multi-center, randomized, double-blind, placebo-controlled Phase 2 trial studying the safety and efficacy of omaveloxolone in patients with FA. Treatment of FA patients with omaveloxolone produced dose- and time-dependent improvements in their modified Friedreich’s Ataxia Rating Scale (mFARS) scores, which are a measure of the neurologic function of FA patients. Reata is currently enrolling approximately 100 FA patients in the registrational part 2 portion of MOXIe and expects to have results in the second half of 2019.
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