Reata Announces Top-Line Data from the Dose-Escalation Cohorts of the Phase 2 Motor Study

Reata Pharmaceuticals (Nasdaq:RETA) a clinical-stage biopharmaceutical company, announced top-line data from the dose-escalation cohorts of the Phase 2 MOTOR trial of omaveloxolone for the treatment of patients with mitochondrial myopathies.  This 12-week, exploratory, dose-ranging trial enrolled 53 patients across six dose levels.  The purpose of the first-in-patient MOTOR trial was to evaluate initial safety, efficacy, pharmacokinetics, and pharmacodynamics of omaveloxolone in this patient population.

As quoted in the press release:

The sample size of six to ten patients randomized to omaveloxolone and two to three randomized to placebo for safety controls at each dose level was based upon a traditional dose-escalation design.  The small number of patients at each dose was not expected to fully characterize safety, efficacy, or pharmacodynamics, but rather to inform the data safety monitoring board and Reata of the appropriate dose to select for future study.  The optimal dose of omaveloxolone associated with robust Nrf2 induction and improvement in markers of mitochondrial function was determined to be 160 mg.  At this dose, significant, placebo-corrected improvements were noted in Nrf2 biomarkers.

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