Reata Pharmaceuticals Announces Presentations at the American Society of Nephrology Kidney Week 2021

Rhea-AI Summary

Reata Pharmaceuticals (NASDAQ: RETA) announced the presentation of clinical data related to bardoxolone methyl at the American Society of Nephrology Kidney Week 2021, scheduled virtually from November 4-7. Key presentations include integrated analyses of bardoxolone's efficacy and safety in Chronic Kidney Disease and Alport syndrome, along with interim findings from various clinical trials. Bardoxolone has Orphan Drug designation for treating Alport syndrome from the FDA and the European Commission. The company continues to advance its clinical programs targeting significant renal diseases.

Positive

• Presentation of clinical data at Kidney Week 2021 could enhance visibility and credibility.
• Bardoxolone has received Orphan Drug designation from the FDA and European authorities for Alport syndrome, potentially leading to expedited development and marketing.
• Positive results reported from ongoing clinical trials, which may favorably impact future regulatory approvals and market potential.

Negative

• Bardoxolone's safety and efficacy are still investigational and have not been established, posing inherent risks in future clinical trials.
• Dependence on regulatory approvals for the advancement of bardoxolone and potential market entry could delay commercialization.

PLANO, Texas--(BUSINESS WIRE)-- 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.

View source version on businesswire.com: https://www.businesswire.com/news/home/20211015005184/en/

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/

Source: Reata Pharmaceuticals, Inc.

FAQ

What is the significance of bardoxolone's presentations at the American Society of Nephrology Kidney Week 2021?

The presentations highlight bardoxolone's clinical data, increasing awareness and potential investor interest.

What designations has bardoxolone received related to Alport syndrome?

Bardoxolone has received Orphan Drug designation from both the FDA and the European Commission for Alport syndrome.

What are the potential impacts of the ongoing clinical trials for bardoxolone on Reata's stock?

Positive trial results could increase investor confidence and enhance stock performance for Reata Pharmaceuticals.

When is the Kidney Week 2021 being held?

The American Society of Nephrology Kidney Week 2021 is scheduled virtually from November 4-7.

What type of drug is bardoxolone?

Bardoxolone is an investigational drug that acts as an activator of Nrf2, targeting chronic kidney disease.