IRVING, Texas, May 31, 2018 (GLOBE NEWSWIRE) -- Reata Pharmaceuticals, Inc. (Nasdaq:RETA), a clinical-stage biopharmaceutical company, today announced that the European Commission (EC) has granted orphan drug designation, based on the positive opinion from the Committee for Orphan Medicinal Products (COMP) of the European Medicines Agency (EMA), for bardoxolone methyl (bardoxolone) for the treatment of Alport syndrome.
Alport syndrome is a rare, genetic form of chronic kidney disease (CKD) caused by mutations in genes encoding type IV collagen, which is a major structural component of the glomerular basement membrane in the kidney. A majority of patients with Alport syndrome develop CKD and many progress to end-stage renal disease. In the Phase 2 portion of the Phase 2/3 CARDINAL study, bardoxolone significantly increased patients’ estimated glomerular filtration rate (eGFR) after 36 weeks of treatment by 11.3 mL/min/1.73 m2 (n=27; p<0.0000001).
"Orphan designation in the European Union is an important milestone for the Company and for Alport syndrome patients. There are currently no 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 designation is granted in Europe to drugs intended for the treatment of life-threatening or chronically debilitating diseases that affect no more than five in 10,000 people in the European Union and for which no satisfactory treatments are available, or where the new therapy has the potential to be a significant benefit to those affected by the disease. Orphan designation provides specific financial and regulatory incentives, including reduced fees, protocol assistance, access to the centralized authorization procedure, and ten years of market exclusivity once the drug is approved. Bardoxolone has previously received orphan drug designation from the FDA for the treatment of Alport syndrome and for connective tissue disease-associated pulmonary arterial hypertension.
About Bardoxolone
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. The FDA has granted orphan designation to bardoxolone for the treatment of Alport syndrome and pulmonary arterial hypertension. Bardoxolone is currently being studied in CARDINAL, a Phase 3 study for the treatment of Alport syndrome, CATALYST, a Phase 3 study for the treatment of connective tissue disease associated pulmonary arterial hypertension, and PHOENIX, a Phase 2 study for the treatment of autosomal dominant polycystic kidney disease, IgA nephropathy, focal segmental glomerulosclerosis, and CKD associated with 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.
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, 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.
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