Bardoxolone methyl: Additional Phase II data

Additional data from the double-blind, U.S. Phase II BEAM trial in 227 patients with moderate to severe CKD and Type II diabetes showed that once-daily 25, 75 and 150 mg bardoxolone methyl significantly increased mean eGFR from baseline to week 52 by 5.8, 10.5 and 9.3 mL/min/1.73 m2, respectively, vs. placebo (p=0.002 for the 25 mg dose and p<0.001 for the 75 and 150 mg doses). Low-, mid- and high-dose bardoxolone significantly increased mean eGFR from baseline to week 24, the primary endpoint, by 8.2, 11.4 and 10.4 mL/min/1.73 m2, respectively, vs. placebo (p<0.001 for all). All 3 doses of bardoxolone also significantly reduced mean uric acid levels from baseline at both weeks 24 and 52 vs. placebo. Furthermore, a non-significantly smaller proportion of patients treated with bardoxolone experienced a decline in eGFR of >25% over 52 weeks vs. placebo (9% vs. 19%, p=0.058). Data were published in the New England Journal of Medicine and presented at the European Renal Association-European Dialysis and Transplant Association meeting in Prague. ...