Reata Announces the Presentation of the Pivotal MOXIe Part 2 Study of Omaveloxolone in Friedreich’s Ataxia at the American Academy of Neurology

Rhea-AI Summary

Reata Pharmaceuticals (Nasdaq: RETA) will present efficacy and safety results from the pivotal MOXIe Part 2 study of its investigational drug, omaveloxolone, for Friedreich’s ataxia on September 24, 2020. This presentation is part of the Emerging Science series hosted by the American Academy of Neurology. The study, led by Dr. David Lynch, was selected from over 150 abstracts. In addition, Dr. Lynch will also share findings at the FARA 2020 Biomarker & Clinical Endpoint Meeting, scheduled for the same day. The safety and efficacy of omaveloxolone have not yet been established.

Positive

• Presentation of pivotal MOXIe Part 2 study results at prominent conferences may enhance visibility.
• Selected as one of 12 late-breaking abstracts from over 150 submissions indicates strong interest and potential significance of findings.

Negative

• The safety and efficacy of omaveloxolone remain unproven, which could affect investor confidence.
• Reliance on ongoing clinical trials adds uncertainty regarding future regulatory approvals and market potential.

PLANO, Texas, Sept. 03, 2020 (GLOBE NEWSWIRE) -- Reata Pharmaceuticals, Inc. (Nasdaq: RETA) (“Reata,” the “Company,” or “we”), a clinical-stage biopharmaceutical company, today announced the forthcoming presentation of efficacy and safety results from the pivotal MOXIe Part 2 study, a randomized, double-blind, placebo-controlled trial of omaveloxolone in Friedreich’s ataxia.

The presentation will take place on September 24, 2020 as part of the 2020 Emerging Science presentations hosted by the American Academy of Neurology (AAN).  David Lynch, M.D., Ph.D., will present the data.  Dr. Lynch is an attending physician at the Children’s Hospital of Philadelphia (CHOP), professor of neurology at the Perelman School of Medicine at the University of Pennsylvania, and the principal investigator of the MOXIe study.

The AAN Science Committee selected this as one of 12 late-breaking abstracts, chosen from more than 150 abstracts submitted to the April 2020 AAN meeting, which was converted to a virtual meeting due to the COVID-19 pandemic.  More information about the AAN presentation can be found at the AAN Emerging Science webpage: https://www.aan.com/education-and-research/research/2020-aan-science-highlights/.

Separately, Dr. Lynch will present the results of the MOXIe Part 2 study at the FARA 2020 Biomarker & Clinical Endpoint Meeting, also scheduled for September 24.  More information about this meeting and Dr. Lynch’s presentation there can be found at https://curefa.org/pdf/research/Agenda-Biomarker2020-draft.pdf.

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.

Contact:
Reata Pharmaceuticals, Inc.
(972) 865-2219
http://reatapharma.com

Investors:
Vinny Jindal
Vice President, Investor Relations and Corporate Communications
(469) 374-8721
ir@reatapharma.com
http://reatapharma.com/contact-us/

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 the detailed factors discussed under the caption “Risk Factors” in its Annual Report on Form 10-K for the fiscal year ended December 31, 2019.  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.

 

FAQ

What is the significance of the MOXIe Part 2 study results for Reata Pharmaceuticals (RETA)?

The MOXIe Part 2 study results are crucial as they provide efficacy and safety data for omaveloxolone, potentially impacting its approval and market entry.

When will Reata Pharmaceuticals present the MOXIe study results?

The MOXIe study results will be presented on September 24, 2020.

Where can I find more information about the AAN presentation from Reata Pharmaceuticals (RETA)?

More information about the AAN presentation can be found on the American Academy of Neurology's Emerging Science webpage.

Who is presenting the results of the MOXIe Part 2 study for Reata Pharmaceuticals (RETA)?

The results will be presented by Dr. David Lynch, the study's principal investigator.

Are there any risks associated with Reata Pharmaceuticals' (RETA) investigational drugs?

Yes, the safety and efficacy of their drugs, including omaveloxolone, have not been established, presenting inherent risks for investors.