Reata Ends Development of Bardoxolone in Chronic Kidney Disease to Focus on Neurology
May 11, 2023
Rare Daily Staff
Reata Pharmaceuticals said in it first quarter financial results and business update that it is ending development of bardoxolone for chronic kidney disease.
The decision affects two rare disease indications: CKD caused by Alport syndrome and CKD caused by autosomal dominant polycystic kidney disease (ADPKD).
The decision was based on results from the AYAME phase 3, multi-center, randomized, double-blind, placebo-controlled trial to evaluate the efficacy and safety of bardoxolone methyl (bardoxolone) for patients with diabetic kidney disease that was conducted by Reata’s partner Kyowa Kirin. The study enrolled 1,013 patients who were treated with 5 to 15 mg of bardoxolone or placebo for three to four years. The primary endpoint of the study was time to onset of a ≥ 30 percent decrease in estimated Glomerular Filtration Rate (eGFR) from baseline or end-stage renal disease (ESRD).
The AYAME study met the primary and key secondary endpoints, and no significant safety issues were observed in patients receiving bardoxolone. However, there was no separation in the occurrence of ESRD events between the bardoxolone and placebo groups after three years of treatment. Based on the results of AYAME and its potential regulatory impact, the companies decided to discontinue their bardoxolone chronic kidney disease programs.
As a result of the discontinuation, Reata said it expects to save near-term capital and resources of more than $100 million that had previously been committed for its CKD program and can now be used to advance Reata’s other programs.
Reata said that it also entered into a new non-dilutive $275 million debt facility that will extend its cash runway through the end of 2026 and the anticipated commercial launch of its recently approved drug Skyclaris for the treatment of Friedreich’s ataxia, a rare, genetic, debilitating, and degenerative neuromuscular disorder.
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