ARTICLE | Clinical News

Reata reports Phase II data for omaveloxolone in mitochondrial myopathies

March 9, 2018 5:17 PM UTC

Reata Pharmaceuticals Inc. (NASDAQ:RETA) reported top-line data from the Phase II MOTOR trial in 53 patients with mitochondrial myopathies showing that omaveloxolone (oral RTA 408) missed the primary endpoint of improving peak workload during exercise testing from baseline to week 12 vs. placebo. Omaveloxolone also missed the secondary endpoint of improving 6-minute walk test (6MWT) distance from baseline to week 12 vs. placebo.

Patients in the double-blind trial received placebo or once-daily 2.5-160 mg oral omaveloxolone. Reata said that with the small number of patients, the trial was not expected to fully characterize the safety, efficacy or pharmacodynamics of the candidate, but rather to inform the company of the appropriate dose for future study. The company said the optimal dose of omaveloxolone associated with "robust" nuclear factor (erythroid-derived 2)-like 2 (NFE2L2; NRF2) induction and improvement in markers of mitochondrial function was determined to be 160 mg...