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news.Reata Pharmaceuticals and Abbott have commenced a multinational, double-blind, placebo-controlled BEACON Phase 3 trial to investigate an antioxidant inflammation modulator bardoxolone methyl in patients who are suffering from chronic kidney disease and type 2 diabetes.
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The trial is intended to evaluate the impact of bardoxolone methyl on time to important clinical outcomes.
The companies expect to recruit around 16,00 patients in the trial who will be randomized in 1:1 ratio to receive 20mg of a reformulated version of bardoxolone methyl or placebo once daily, across 300 sites worldwide.
The primary endpoint of the trial 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.
The secondary endpoint of the trial includes change in 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.
Renal Associates Research Division in San Antonio director Pablo Pergola said 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," Pergola said.