Reata, Abbott initiate global phase 3 study of bardoxolone methyl

Reata Pharmaceuticals Inc and Abbott announced the initiation of a pivotal phase 3 clinical trial to evaluate the safety and efficacy of bardoxolone methyl in patients with chronic kidney disease (eGFR of 15-29 mL/min/1.73 m2) and type 2 diabetes.

The trial, known as BEACON (Bardoxolone methyl EvAluation in patients with Chronic kidney disease and type 2 diabetes: the Occurrence of renal eveNts), is said to be 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.

The primary efficacy endpoint will be a time-to-first-event composite consisting of progression to end-stage renal disease (ESRD), defined as the need for chronic dialysis or renal transplant, and cardiovascular death. Secondary endpoints will include change in estimated glomerular filtration rate (eGFR) and a time-to-first-event composite consisting of hospitalization for congestive heart failure (CHF), non-fatal myocardial infarction (MI), non-fatal stroke and cardiovascular death.

More information on the trial is available at www.clinicaltrials.gov (clinical trial identifier: NCT01351675).

"We are pleased to announce that the phase 3 BEACON trial is underway," said Pablo E Pergola, MD, PhD, Director of Renal Associates' Research Division in San Antonio, Texas, who screened the first patient of the study. "There are few therapeutic options available today that slow the progression of CKD. Results from the phase 2 BEAM trial suggest that bardoxolone methyl may improve measures of kidney function in patients with moderate to severe CKD and Type 2 diabetes. We look forward to further evaluating the drug candidate's effects on clinical outcomes in this patient population."

Final results from the 52-week phase 2b BEAM study will be presented during a Late-Breaking Clinical Trials session on June 24 at the 2011 European Renal Association-European Dialysis and Transplant Association (ERA-EDTA) Congress in Prague, Czech Republic.