Reata Pharmaceuticals Omaveloxolone for Friedreich’s Ataxia
On October 14, 2019 Reata Pharmaceuticals (RETA) announced the Part 2 portion of its Phase 2 MOXIe trial, with its product omaveloxolone, met its primary endpoint in modifying Friedreich’s ataxia (FA). The largest change occurred in the modified Friedreich’s Ataxia Rating Scale (mFARS) after 48 weeks of treatment.
Patients treated with omaveloxolone 150 mg/day demonstrated a statistically significant, 2.40 point improvement in mFARS after 48 weeks of treatment. Omaveloxolone was generally well-tolerated.
The company plans to proceed with the submission of regulatory filings for marketing approval in the United States and internationally.
Modified Friedreich’s Ataxia Rating Scale
The mFARS is a physician-assessed neurological rating scale used to measure FA disease progression. It includes four sections that measure the patient’s performance of activities such as speaking and swallowing, upper limb coordination, lower limb coordination, and standing and walking. The United States Food and Drug Administration (FDA) has indicated that mFARS is an acceptable primary endpoint to evaluate the effect of omaveloxolone for the treatment of patients with FA.