IRVING, Texas, June 04, 2019 — Reata Pharmaceuticals, Inc. (Nasdaq: RETA), a clinical-stage biopharmaceutical company, today announced that four abstracts highlighting Reata’s progress in developing bardoxolone methyl (bardoxolone) for the treatment of chronic kidney disease (CKD) will be presented at the 56th Congress of the European Renal Association and European Dialysis and Transplant Association (ERA-EDTA). The Congress will take place on June 13 – 16, 2019 in Budapest, Hungary.
An oral presentation will discuss molecular insights into the effects of bardoxolone in cellular models of polycystic kidney disease (PKD), including data demonstrating that bardoxolone reduces cyst formation in cellular models of PKD. The poster presentations will include baseline characteristics for the Phase 3 portion of CARDINAL, a Phase 2/3 study of bardoxolone for the treatment of Alport syndrome, and safety and efficacy data from the Phase 2 PHOENIX study of bardoxolone in patients with rare forms of CKD. One PHOENIX poster will discuss data from the focal segmental glomerulosclerosis (FSGS) cohort of PHOENIX, and the other will discuss data from all four cohorts of PHOENIX.
Abstracts to be presented are summarized below.
Title: The Nrf2 Activator Bardoxolone Methyl Inhibits Cyst Formation, Reduces Inflammation, and Improves Mitochondrial Function in Cellular Models of Polycystic Kidney Disease Presenter: Christian Wigley, Ph.D., Reata’s Vice President of Research Oral: Friday, June 14th, 8:39 a.m. – 8:52 a.m.
Title: Baseline Characteristics in the “CARDINAL” Trial: A Phase 3 Study of the Efficacy and Safety of Bardoxolone Methyl in Patients with Alport Syndrome Presenter: Bertrand Knebelmann, M.D., Division de Néphrologie, Hôpital Necker, Assistance Publique-Hôpitaux de Paris, Paris, France Poster FP179: Friday, June 14th, 9:30 a.m. – 10:45 a.m. and 4:30 p.m. – 5:00 p.m.
Title: Safety and Efficacy of Bardoxolone Methyl in Patients with Rare Chronic Kidney Diseases Presenter: Pablo E. Pergola, M.D., Ph.D., Research Director, Renal Associates, PA, San Antonio, TX Poster FP117: Friday, June 14th, 9:30 a.m. – 10:45 a.m. and 4:30 p.m. – 5:00 p.m.
Title: Safety and Efficacy of Bardoxolone Methyl in Patients with Focal Segmental Glomerulosclerosis Presenter: Pablo E. Pergola, M.D., Ph.D., Research Director, Renal Associates, PA, San Antonio, TX Poster FP152: Friday, June 14th, 9:30 a.m. – 10:45 a.m. and 4:30 p.m. – 5:00 p.m.
Bardoxolone is an experimental, oral, once-daily activator of Nrf2, a transcription factor that induces molecular pathways that promote restoration of mitochondrial function, reduction of oxidative stress, and inhibition of pro-inflammatory signaling. The United States Food and Drug Administration has granted orphan drug designation to bardoxolone for the treatment of Alport syndrome and pulmonary arterial hypertension. The European Commission has granted orphan drug designation to bardoxolone for the treatment of Alport syndrome. In addition to CARDINAL, bardoxolone is currently being studied in FALCON, a Phase 3 study for the treatment of autosomal dominant polycystic kidney disease (ADPKD), CATALYST, a Phase 3 study for the treatment of connective tissue disease-associated pulmonary arterial hypertension, and AYAME, a Phase 3 study for the treatment of diabetic kidney disease in Japan. AYAME is being conducted by our licensee Kyowa Hakko Kirin Co., Ltd. The Phase 2 PHOENIX program studied bardoxolone in patients with ADPKD, FSGS, IgA nephropathy, and type 1 diabetic CKD. PHOENIX is complete, and results from all four cohorts have now been released.
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 restoration of mitochondrial function, reduction of oxidative stress, and inhibition of pro-inflammatory signaling. Bardoxolone and omaveloxolone are investigational drugs, and their safety and efficacy have not been established by any agency.
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, 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,” 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) 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 (iv) 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
Investors: Vinny Jindal Vice President, Strategy (469) 374-8721 [email protected]
Media: Matt Middleman, M.D. LifeSci Public Relations (646) 627-8384 [email protected]
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