Reata Pharmaceuticals Announces Presentations at Upcoming Medical Conferences

Rhea-AI Summary

Reata Pharmaceuticals (Nasdaq: RETA) announced the presentation of clinical data for bardoxolone methyl at two nephrology conferences. The World Congress of Nephrology 2021 will feature an interim analysis of the EAGLE trial focusing on chronic kidney disease due to Alport syndrome. The ERA-EDTA Congress will present pediatric data from the Phase 3 CARDINAL trial. Bardoxolone, an investigational drug, is recognized for its therapeutic potential in CKD and has received Orphan Drug designation from the FDA and European Commission for Alport syndrome treatment.

PLANO, Texas, March 29, 2021 (GLOBE NEWSWIRE) -- 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”) will be presented at two upcoming nephrology conferences including The World Congress of Nephrology 2021 being held virtually from April 15 – 19, 2021 and the 58^th European Renal Association and European Dialysis and Transplant Association (“ERA-EDTA”) Congress being held from June 5 – 8, 2021 in Berlin, Germany and virtually.

The poster presentation at The World Congress of Nephrology 2021 will report results from EAGLE, an open-label, long-term extension study of bardoxolone in patients with chronic kidney disease (“CKD”) caused by Alport syndrome.

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: Roser Torra, MD, PhD, Inherited Kidney Disorders, Nephrology Department, Fundacio Puigvert, Instituto de Investigacion Carlos III, Universitat Autonoma de Barcelona, Barcelona, Spain
Abstract: WCN21-0356; poster will be available throughout the conference

An abstract describing pediatric data from the Phase 3 CARDINAL trial of bardoxolone in patients with CKD caused by Alport syndrome was selected for oral presentation at the 58th ERA-EDTA Congress.

Abstract Title: Safety of Bardoxolone Methyl in Pediatric Patients with Alport Syndrome in CARDINAL Phase 3 Trial
Presenter: Bradley Warady, MD, Director, Division of Pediatric Nephrology, Children's Mercy Kansas City, Kansas City, MO
Session: Interventions in CKD; Abstract number FC 023; Presented June 6, 2021, Session Time: 11:45 – 13:15 CEST

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 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., 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.   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.

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

Investor Relations & Media:
Manmeet Soni (469) 299-9130
Andres Lorente (469) 442-4883
ir@reatapharma.com
media@reatapharma.com
https://www.reatapharma.com/contact-us/

FAQ

What clinical data will be presented by Reata Pharmaceuticals at nephrology conferences?

Reata Pharmaceuticals will present clinical data for bardoxolone methyl at The World Congress of Nephrology 2021 and the 58th ERA-EDTA Congress, focusing on chronic kidney disease caused by Alport syndrome.

When will the World Congress of Nephrology 2021 take place?

The World Congress of Nephrology 2021 will be held virtually from April 15 to April 19, 2021.

What will be presented at the ERA-EDTA Congress regarding bardoxolone?

An abstract on pediatric data from the Phase 3 CARDINAL trial of bardoxolone in patients with Alport syndrome will be presented at the ERA-EDTA Congress, scheduled for June 5 to June 8, 2021.

What is bardoxolone and its significance according to the press release?

Bardoxolone is an investigational drug that activates Nrf2 to address inflammation and oxidative stress, with Orphan Drug designation for treating Alport syndrome and autosomal dominant polycystic kidney disease.

What are the future studies planned for bardoxolone?

Reata Pharmaceuticals is conducting several studies for bardoxolone, including Phase 3 trials for Alport syndrome and autosomal dominant polycystic kidney disease, and a Phase 2 study for patients at risk of rapid CKD progression.