Reata Announces Plan For Global Phase 2/3 Trial In Chronic Kidney Disease Caused By Alport Syndrome

- Conference call and webcast November 14   at   12:00 p.m. EST   -
  • Received Guidance from the FDA on Key Design Aspects of a Single, Pivotal Trial in Alport Syndrome with an eGFR-Based Endpoint
  • Alport Syndrome is an Orphan Disease that Affects Children and Adults and has No Approved Therapy
  • Alport Syndrome and Diabetic Chronic Kidney Disease have Similar Characteristics
  • Reata Expects Data From Prior CKD Program of 2,600 Patients to Translate to Alport Syndrome

IRVING, Texas, Nov. 14, 2016 (GLOBE NEWSWIRE) -- Reata Pharmaceuticals, Inc. (NASDAQ:RETA) ("Reata" or "the Company") today announced a potential path to approval for bardoxolone methyl in a new indication, the treatment of chronic kidney disease ("CKD") caused by Alport syndrome.  In a Type B meeting on October 5 th, 2016, the U.S. Food and Drug Administration ("FDA") provided guidance that a single, pivotal trial utilizing a retained estimated glomerular filtration rate ("eGFR") endpoint could serve as the basis for approval in this life-threatening, orphan disease.

"We approached the FDA with a design for a Phase 2 study in Alport syndrome.  The meeting was very collaborative, and the FDA provided us with guidance on a more efficient path to potential registration conducting a single, pivotal trial," said Warren Huff, CEO of Reata Pharmaceuticals.  "Bardoxolone methyl has a novel mechanism of action that has the potential to address the chronic inflammation and renal function decline that are key features of Alport syndrome.  Our Alport syndrome program will be similar in scope to CATALYST, our ongoing Phase 3 trial in patients with connective tissue disease associated pulmonary arterial hypertension."

Alport syndrome is a rare and serious hereditary disease with no approved therapies that affects approximately 12,000 people in the United States and 40,000 globally.  Almost all patients with Alport syndrome develop end-stage renal disease ("ESRD"), and approximately 50% of male patients require dialysis or kidney transplant by the age of 25.  The inflammatory processes that promote disease progression in Alport syndrome are similar to those underlying other forms of CKD.  Bardoxolone methyl has shown improvements in eGFR and other markers of renal function in studies that enrolled over 2,600 patients, including primarily patients with CKD caused by type 2 diabetes.

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