Reata reports top-line data for omaveloxolone in Freidreich’s ataxia
pharmafile | October 15, 2019 | News story | Manufacturing and Production |
Reata has reported that Part 2 of its mid-stage MOXIe trial of its Nrf2 activator omaveloxolone met its primary endpoint.
Last week the company agreed to pay AbbVie $330 million to reacquire rights to a portfolio of Nrf2 activators, including omaveloxolone globally and bardoxolone outside the US, among others.
Based on the results of the MOXIe trial, Reata plans to move ahead with filings seeking marketing approval of omaveloxolone in the US and internationally.
Reata CEO Warren Huff said: “The MOXIe trial with omaveloxolone is the first study to demonstrate a significant improvement in neurological function in patients with Friedreich’s ataxia.”
Part 2 of the trial enrolled 103 patients with Friedreich’s ataxia who were randomised to receive omaveloxolone or placebo. The primary endpoint was change in the modified Friedreich’s Ataxia Rating Scale (mFARS) relative to placebo after 48 weeks of treatment.
The results showed that omaveloxolone produced a significant, placebo-corrected 2.40-point improvement in mFARS after 48 weeks. More specifically, patients treated with omaveloxolone achieved a mean improvement in mFARS of -1.55 points from baseline compared with a mean worsening of +0.85 points for placebo.
The company noted that the improvements “were time-dependent, increasing over the course of treatment with the largest improvement observed after 48 weeks”.
The company plans to present detailed MOXIe study results at a future medical conference, having reported positive results from Part 1 of the trial in 2017.
Omaveloxolone has received orphan drug status by the FDA for the treatment of Friedreich’s ataxia and malignant melanoma.
Nik Kiran
