Reata Pharmaceuticals Announces Presentations at the American Society of Nephrology Kidney Week 2021
(Nasdaq: RETA) (Reata, the Company, or we), a clinical-stage biopharmaceutical company, today announced that abstracts highlighting clinical data for bardoxolone methyl (bardoxolone) and disease education data on Alport syndrome will be presented at the American Society of Nephrology Kidney Week 2021 being held virtually from November 4 7, 2021.
Reata Pharmaceuticals, Inc. (Nasdaq: RETA) (“Reata,” the “Company,” or “we”), a clinical-stage biopharmaceutical company, today announced that abstracts highlighting clinical data for bardoxolone methyl (“bardoxolone”) and disease education data on Alport syndrome will be presented at the American Society of Nephrology Kidney Week 2021 being held virtually from November 4 – 7, 2021.
The abstracts for the oral and poster presentations are listed below and are available on the conference website at https://www.asn-online.org/education/kidneyweek/.
Oral Presentation:
Abstract Title: Integrated Efficacy and Safety of Bardoxolone Methyl in Chronic Kidney Disease
Presenter: Laura Mariani, MD, Department of Internal Medicine, Division of Nephrology, University of Michigan, Ann Arbor, Michigan, USA
Session: OR2102. Findings from Landmark Trials, Other Kidney Trials, and Observational Studies
Abstract Publication #: FR-OR54
Poster Presentations:
Abstract Title: Integrated Analysis of the Efficacy and Safety of Bardoxolone Methyl in Patients with Alport Syndrome
Presenter: Bradley Warady, MD, Division of Pediatric Nephrology, Children's Mercy Kansas City, Kansas City, Missouri, USA
Abstract Publication #: PO1301
Abstract Title: Interim Analysis of the EAGLE Trial: An Open-Label Study to Assess the Long-Term Safety and Tolerability of Bardoxolone Methyl in Patients with Alport Syndrome
Presenter: Pablo E. Pergola, MD, PhD, Renal Associates PA, San Antonio, Texas, USA
Abstract Publication #: PO1300
Abstract Title: Patient Global Impression of Change in Patients with Alport Syndrome in the CARDINAL Phase 3 Trial
Presenter: Glenn M. Chertow, MD, MPH, Division of Nephrology, Department of Medicine, Stanford University School of Medicine, Palo Alto, California, USA
Abstract Publication #: PO1303
Abstract Title: KIDNEYCODE: A Genetic Testing Program for Patients with Chronic Kidney Disease
Presenter: Prasad Devarajan, MD, Cincinnati Children's Hospital Medical Center, University of Cincinnati College of Medicine, Cincinnati, Ohio, USA
Abstract Publication #: PO1292
Abstract Title: Healthcare Resource Utilization by Patients with Alport Syndrome in the US: A Retrospective Claims Analysis
Presenter: Baris Deniz, Reata Pharmaceuticals, Plano, Texas, United States
Abstract Publication #: PO1296
Abstract Title: Characterization of Patients with Alport Syndrome in the United States: A Retrospective Analysis of Medical Claims
Presenter: Baris Deniz, Reata Pharmaceuticals, Plano, Texas, United States
Abstract Publication #: PO1295
About Bardoxolone
Bardoxolone is an investigational, once-daily, orally administered 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 U.S. Food and Drug Administration has granted Orphan Drug designation to bardoxolone for the treatment of Alport syndrome and autosomal dominant polycystic kidney disease (“ADPKD”). The European Commission has granted Orphan Drug designation in Europe to bardoxolone for the treatment of Alport syndrome.
In November of 2020 we completed the Phase 3 CARDINAL trial of bardoxolone in patients with chronic kidney disease (“CKD”) caused by Alport syndrome. In addition to the CARDINAL Phase 3 study, bardoxolone is currently being studied in FALCON, a Phase 3 study for the treatment of ADPKD, MERLIN, a Phase 2 study for the treatment of patients with CKD at risk of rapid progression, and AYAME, a Phase 3 study for the treatment of diabetic kidney disease that is being conducted by our licensee, Kyowa Kirin Co., Ltd. (“KKC”), in Japan. Bardoxolone treatment produced positive results in the PHOENIX Phase 2 study in patients with CKD caused by ADPKD, IgA nephropathy, focal segmental glomerulosclerosis, and type 1 diabetes.
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. We possess exclusive, worldwide rights to develop, manufacture, and commercialize bardoxolone, omaveloxolone, and our next-generation Nrf2 activators, excluding certain Asian markets for bardoxolone in certain indications, which are licensed to KKC. 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 the detailed factors discussed under the caption “Risk Factors” in its Annual Report on Form 10-K for the fiscal year ended December 31, 2020. 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.
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