Reata Announces Initiation of Investigator-Sponsored Study Evaluating Bardoxolone for Complications Associated with COVID-19
Reata Pharmaceuticals (Nasdaq: RETA) announced the initiation of the BARCONA study at NYU Grossman School of Medicine to explore the effects of bardoxolone methyl on COVID-19 patients. The Phase 2 Investigator-Sponsored Trial will focus on assessing safety and is prompted by the high incidence of acute kidney injury among COVID-19 patients. Bardoxolone has shown anti-inflammatory properties in prior studies involving over 3,000 patients with chronic kidney disease. Reata is supplying the drug for this trial, aiming to further research the therapeutic potential of bardoxolone.
- Initiation of BARCONA study focusing on bardoxolone's effect on COVID-19, indicating ongoing research and potential future applications.
- Bardoxolone has shown promise in prior studies, demonstrating anti-inflammatory activity and improvements in kidney function.
- Safety and efficacy of bardoxolone and omaveloxolone remain unestablished, which could limit market perception and investor confidence.
PLANO, Texas, July 28, 2020 (GLOBE NEWSWIRE) -- Reata Pharmaceuticals, Inc. (Nasdaq: RETA) (“Reata,” the “Company,” or “we”), a clinical-stage biopharmaceutical company, today announced that researchers at NYU Grossman School of Medicine (“NYU”), led by Sripal Bangalore, MD, interventional cardiologist and professor of Medicine, are initiating an Investigator-Sponsored Trial (“IST”), known as BARCONA, to study the effect of bardoxolone methyl (“bardoxolone”) in patients suffering from COVID-19. At NYU’s request, Reata is providing drug supply for the trial. NYU will be initiating the Phase 2 BARCONA study with a primary endpoint of safety.
The severity of COVID-19 and the development of systemic complications is associated with excessive, systemic inflammation, which can result in dysfunction of the lungs, kidneys, and other organs. Acute kidney injury (“AKI”) has been reported to occur in up to
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 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.
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Vinny Jindal
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(469) 374-8721
ir@reatapharma.com
http://reatapharma.com/contact-us/
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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
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