Reata and Abbott Initiate Global Phase 3 Study of Bardoxolone Methyl in Patients With Chronic Kidney Disease and Type 2 Diabetes

Reata Pharmaceuticals, Inc. and Abbott ABT announced today the initiation of a pivotal Phase 3 clinical trial to evaluate the safety and efficacy of bardoxolone methyl in patients with chronic kidney disease and type 2 diabetes. The trial, known as BEACON, is the first multinational, double-blind, placebo-controlled study designed to assess the impact of bardoxolone methyl on time to important clinical outcomes. Approximately 1,600 patients at 300 sites worldwide – including in Austria, Australia, Belgium, Canada, Czech Republic, France, Germany, Israel, Italy, Mexico, Spain, Sweden, United Kingdom and United States – will be enrolled in the trial and randomized 1:1 to receive 20 mg of a reformulated version of bardoxolone methyl or placebo once daily. Results are expected in 2013.