Reata Announces Publication of Results From Pivotal Moxie Trial of Omaveloxolone in Patients with Friedreich’s Ataxia

Rhea-AI Summary

Reata Pharmaceuticals (Nasdaq: RETA) recently announced the publication of pivotal results from the MOXIe trial in Annals of Neurology, highlighting the efficacy of omaveloxolone in treating Friedreich's ataxia (FA). In this double-blind study, patients receiving 150 mg daily of omaveloxolone showed a statistically significant improvement in mFARS scores (mean improvement of 2.40 points, p=0.014) after 48 weeks, with good tolerability. Currently, omaveloxolone is an investigational drug with orphan drug designation from the FDA for FA, which affects ~5,000 U.S. patients.

Positive

• Omaveloxolone demonstrated a statistically significant mean improvement of 2.40 points in mFARS scores after 48 weeks (p=0.014).
• The drug was generally well tolerated by patients in the study.
• Omaveloxolone has received orphan drug designation from the FDA for the treatment of FA.

Negative

• None.

PLANO, Texas, Oct. 26, 2020 (GLOBE NEWSWIRE) -- Reata Pharmaceuticals, Inc. (Nasdaq: RETA) (“Reata,” the “Company,” or “we”), a clinical-stage biopharmaceutical company, today announced that results from the pivotal part 2 portion of the MOXIe trial evaluating the efficacy and safety of omaveloxolone in patients with Friedreich’s ataxia (“FA”) were published in the journal Annals of Neurology.

MOXIe was a randomized, double-blind, placebo-controlled study, and patients with genetically confirmed FA and baseline modified Friedreich’s Ataxia Rating Scale (mFARS) scores between 20 and 80 were randomized 1:1 to receive placebo or 150 mg of omaveloxolone daily. The primary endpoint was change from baseline in mFARS score at 48 weeks. Patients treated with omaveloxolone experienced a statistically significant, placebo-corrected mean improvement in mFARS of 2.40 points after 48 weeks of treatment (p=0.014). Omaveloxolone was generally reported to be well tolerated in this study.

The publication entitled “Safety and Efficacy of Omaveloxolone in Friedreich’s Ataxia (MOXIe Study)” can be accessed online at https://doi.org/10.1002/ana.25934.

About Friedreich's Ataxia

FA is an inherited, debilitating, and degenerative neuromuscular disorder that is typically diagnosed during adolescence and can ultimately lead to premature death. Patients with FA experience progressive loss of coordination, muscle weakness, and fatigue, which commonly progresses to motor incapacitation and wheelchair reliance. Symptoms generally occur in children, with patients requiring a wheelchair by their teens or early 20s. FA affects approximately 5,000 children and adults in the United States and 22,000 globally. Currently, there are no treatments approved by the U.S. Food and Drug Administration (“FDA”) for FA.

About Omaveloxolone

Omaveloxolone is an experimental, oral, once-daily activator of Nrf2, a transcription factor that induces molecular pathways that promote the resolution of inflammation by restoring mitochondrial function, reducing oxidative stress, and inhibiting pro-inflammatory signaling. The FDA and the European Commision have granted orphan drug designation to omaveloxolone for the treatment of FA.

About Reata Pharmaceuticals, Inc.

Reata is a clinical-stage biopharmaceutical company that develops novel therapeutics for patients with serious or life-threatening diseases by targeting molecular pathways involved in the regulation of cellular metabolism and inflammation. Reata’s two most advanced clinical candidates, bardoxolone methyl (“bardoxolone”) and omaveloxolone, target the important transcription factor Nrf2 that promotes the resolution of inflammation by restoring mitochondrial function, reducing oxidative stress, and inhibiting pro-inflammatory signaling. Bardoxolone and omaveloxolone are investigational drugs, and their safety and efficacy have not been established by any agency.

Forward-Looking Statements

This press release includes certain disclosures that contain “forward-looking statements,” including, without limitation, statements regarding the success, cost and timing of our product development activities and clinical trials, our plans to research, develop and commercialize our product candidates, our plans to submit regulatory filings, and our ability to obtain and retain regulatory approval of our product candidates. You can identify forward-looking statements because they contain words such as “believes,” “will,” “may,” “aims,” “plans,” “model,” and “expects.” Forward-looking statements are based on Reata’s current expectations and assumptions. Because forward-looking statements relate to the future, they are subject to inherent uncertainties, risks, and changes in circumstances that may differ materially from those contemplated by the forward-looking statements, which are neither statements of historical fact nor guarantees or assurances of future performance. Important factors that could cause actual results to differ materially from those in the forward-looking statements include, but are not limited to, (i) the timing, costs, conduct, and outcome of our clinical trials and future preclinical studies and clinical trials, including the timing of the initiation and availability of data from such trials; (ii) the timing and likelihood of regulatory filings and approvals for our product candidates; (iii) whether regulatory authorities determine that additional trials or data are necessary in order to obtain approval; (iv) the potential market size and the size of the patient populations for our product candidates, if approved for commercial use, and the market opportunities for our product candidates; and (v) other factors set forth in Reata’s filings with the U.S. Securities and Exchange Commission, including its Annual Report on Form 10-K, under the caption “Risk Factors.” The forward-looking statements speak only as of the date made and, other than as required by law, we undertake no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise.

Contact:
Reata Pharmaceuticals, Inc.
(972) 865-2219
https://www.reatapharma.com/contact-us/

Investor Relations:
Vinny Jindal
Vice President, Investor Relations and Corporate Communications
(469) 374-8721
ir@reatapharma.com
https://www.reatapharma.com/

FAQ

What were the results of the MOXIe trial for omaveloxolone published by Reata Pharmaceuticals?

The MOXIe trial showed a statistically significant improvement of 2.40 points in mFARS scores for patients receiving omaveloxolone after 48 weeks.

What condition is omaveloxolone being tested for by Reata Pharmaceuticals?

Omaveloxolone is being tested for Friedreich's ataxia, a debilitating neuromuscular disorder.

When were the results of the MOXIe trial published?

The results were published on October 26, 2020, in the journal Annals of Neurology.

What is the primary endpoint of the MOXIe trial for omaveloxolone?

The primary endpoint was the change from baseline in mFARS score after 48 weeks of treatment.

How many patients in the U.S. are affected by Friedreich's ataxia?

Approximately 5,000 patients in the United States are affected by Friedreich's ataxia.