Reata Announces Publication of Results From Pivotal Moxie Trial of Omaveloxolone in Patients with Friedreich’s Ataxia
PLANO, Texas, Oct. 26, 2020 (GLOBE NEWSWIRE) — Reata Pharmaceuticals, Inc. (Nasdaq: RETA) (“Reata,” the “Company,” or “we”), a clinical-stage biopharmaceutical company, today announced that results from the pivotal part 2 portion of the MOXIe trial evaluating the efficacy and safety of omaveloxolone in patients with Friedreich’s ataxia (“FA”) were published in the journal Annals of Neurology.
MOXIe was a randomized, double-blind, placebo-controlled study, and patients with genetically confirmed FA and baseline modified Friedreich’s Ataxia Rating Scale (mFARS) scores between 20 and 80 were randomized 1:1 to receive placebo or 150 mg of omaveloxolone daily. The primary endpoint was change from baseline in mFARS score at 48 weeks. Patients treated with omaveloxolone experienced a statistically significant, placebo-corrected mean improvement in mFARS of 2.40 points after 48 weeks of treatment (p=0.014). Omaveloxolone was generally reported to be well tolerated in this study.
The publication entitled “Safety and Efficacy of Omaveloxolone in Friedreich’s Ataxia (MOXIe Study)” can be accessed online at https://doi.org/10.1002/ana.25934.
About Friedreich’s Ataxia
FA is an inherited, debilitating, and degenerative neuromuscular disorder that is typically diagnosed during adolescence and can ultimately lead to premature death. Patients with FA experience progressive loss of coordination, muscle weakness, and fatigue, which commonly progresses to motor incapacitation and wheelchair reliance. Symptoms generally occur in children, with patients requiring a wheelchair by their teens or early 20s. FA affects approximately 5,000 children and adults in the United States and 22,000 globally. Currently, there are no treatments approved by the U.S. Food and Drug Administration (“FDA”) for FA.
Omaveloxolone is an experimental, oral, once-daily activator of Nrf2, a transcription factor that induces molecular pathways that promote the resolution of inflammation by restoring mitochondrial function, reducing oxidative stress, and inhibiting pro-inflammatory signaling. The FDA and the European Commision have granted orphan drug designation to omaveloxolone for the treatment of FA.
About Reata Pharmaceuticals, Inc.
Reata is a clinical-stage biopharmaceutical company that develops novel therapeutics for patients with serious or life-threatening diseases by targeting molecular pathways involved in the regulation of cellular metabolism and inflammation. Reata’s two most advanced clinical candidates, bardoxolone methyl (“bardoxolone”) and omaveloxolone, target the important transcription factor Nrf2 that promotes the resolution of inflammation by restoring mitochondrial function, reducing oxidative stress, and inhibiting pro-inflammatory signaling. Bardoxolone and omaveloxolone are investigational drugs, and their safety and efficacy have not been established by any agency.
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Reata Pharmaceuticals, Inc.