IRVING, Texas, July 10, 2017 (GLOBE NEWSWIRE) -- Reata Pharmaceuticals, Inc. (Nasdaq:RETA) (“Reata” or “the Company”), a clinical-stage biopharmaceutical company, today announced that the United States Food and Drug Administration (“FDA”) has granted orphan designation to bardoxolone methyl for the treatment of Alport syndrome.
Earlier this year, Reata initiated a Phase 2/3 clinical study to evaluate bardoxolone methyl (“bardoxolone”) in patients with chronic kidney disease (“CKD”) caused by Alport syndrome. The purpose of the study is to determine if Alport syndrome patients experience improvements in kidney function similar to those observed in multiple, previous trials of bardoxolone in patients with other forms of CKD. Reata expects data from the Phase 2 portion of the trial to be available by year-end 2017.
"This orphan designation is an important milestone for the Company and for Alport syndrome patients. There are currently no FDA-approved treatments for Alport syndrome, and we hope to demonstrate that bardoxolone can serve as a safe and effective treatment option for these patients," said Warren Huff, Chief Executive Officer of Reata.
Orphan status is granted to treatments for diseases that affect fewer than 200,000 people in the United States and provides specific incentives for therapies intended for the treatment, diagnosis, or prevention of rare diseases. The orphan designation will provide Reata with development incentives, including tax credits for clinical testing, exemption from a prescription drug user fee, and seven years of market exclusivity.
About Alport Syndrome
Alport syndrome is a rare, genetic form of CKD caused by mutations in the genes encoding type IV collagen, which is a major structural component of the glomerular basement membrane (“GBM”) in the kidney. The abnormal expression of type IV collagen causes loss of GBM integrity, abnormal leakage of proteins through the GBM, and excessive reabsorption of protein in the proximal tubules of the kidney. Like other forms of CKD, excessive reabsorption of protein in the tubules induces oxidative stress, chronic inflammation, and renal interstitial inflammation and fibrosis.
Alport syndrome affects approximately 12,000 people in the United States and approximately 40,000 people globally. Almost all patients with Alport syndrome develop end-stage renal disease, and approximately 50% of male patients require dialysis or a kidney transplant by the age of 25. There are currently no approved therapies to treat Alport syndrome.
About Bardoxolone Methyl
Bardoxolone is an experimental, oral, once-daily 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. Bardoxolone is currently being studied in CATALYST, a Phase 3 clinical trial in patients with connective tissue disease associated pulmonary arterial hypertension (CTD-PAH).
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 to restore mitochondrial function, reduce oxidative stress, and resolve inflammation.
Forward-Looking Statements
This press release includes certain disclosures which 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 are 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.