Shares of Texas-based Reata Pharmaceuticals are up nearly 40% in premarket trading after the company announced its mid-stage trial of omaveloxolone in patients with Friedreich’s ataxia (FA) met its primary endpoint compared to placebo and sets up a potential regulatory filing.
Reata announced late Monday that the second part of its Phase II MOXIe trial met the goal of modified Friedreich’s Ataxia Rating Scale (mFARS) after 48 weeks of treatment. Patients treated with a 150 mg daily dose of omaveloxolone saw a “statistically significant, placebo-corrected 2.40 point improvement, a decrease, in mFARS at the 48-week mark, Reata said. Results from the Phase II trial show that patients treated with omaveloxolone experienced a mean improvement in mFARS of -1.55 points from baseline, while patients treated with placebo experienced a mean worsening in mFARS of +0.85 points from baseline.
The mFARS is a physician-assessed neurological rating scale used to measure FA disease progression. The test includes four sections that measure the patient’s performance of activities, including speaking and swallowing, upper limb coordination, lower limb coordination, and standing and walking. The United States Food and Drug Administration indicated that mFARS is an acceptable primary endpoint to evaluate the effect of omaveloxolone for the treatment of patients with FA, the company said.
The announcement of the Phase II data came less than a week after Reata reacquired all rights to omaveloxolone and other drugs in its platform from AbbVie. As part of the deal to reacquire the rights, Reata will pay AbbVie $330 million. The company will pay $75 million by the end of this year and the remainder in installments throughout 2020 and 2021.
Based on the results of the Phase II trial, Reata plans to begin talks FDA and other regulatory bodies regarding potential filing of New Drug Applications. Full results of the Phase II trial will be presented at a future medical conference, the company noted.