Reata Pharmaceuticals, Inc. and Abbott announced the initiation of a pivotal phase III clinical trial to evaluate the safety and efficacy of bardoxolone methyl in patients with Chronic Kidney Disease (CKD) (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 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.
“We are pleased to announce that the phase III 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 II 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 II b 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.
CKD is a progressive loss of kidney function over a period of months or years that can be caused by a number of conditions, including diabetes and high blood pressure. CKD is a highly prevalent condition worldwide with numbers expected to rise over the next decade. In the United States there are more than 26 million patients with CKD, and more than 500,000 patients with ESRD.
Bardoxolone Methyl is a novel, first-in-class Antioxidant Inflammation Modulator (AIM). Bardoxolone methyl is an Nrf2 activator, thereby inducing the transcription of genes that reduce oxidative stress and suppress important inflammatory mediators.
In January 2010, Reata and Kyowa Hakko Kirin (KHK) announced a licensing agreement providing KHK with the exclusive rights to develop and commercialize bardoxolone methyl in Japan and other selected Asian markets. In September 2010, Reata formed a strategic partnership with Abbott for the commercialization of bardoxolone methyl in other ex-US markets. Reata retains exclusive rights to bardoxolone methyl in the US.
Reata Pharmaceuticals is the leader in discovering and developing novel, oral anti-inflammatory drugs that activate Nrf2, the primary regulator of cellular antioxidant and detoxification enzymes.
Abbott is a global, broad-based health care company devoted to the discovery, development, manufacturing and marketing of pharmaceuticals and medical products, including nutritionals, devices and diagnostics.