Reata reports Phase II data for bardoxolone methyl in CKD

Reata Pharmaceuticals Inc. (NASDAQ:RETA) reported data from 30 patients with chronic kidney disease (CKD) caused by Alport syndrome in the open-label Phase II portion of the Phase II/III CARDINAL trial showing that once-daily oral bardoxolone methyl (RTA 402) significantly improved mean estimated glomerular filtration rate (eGFR) by 6.9 mL/min/1.73 m² at week 4 compared to baseline (p<0.0005) and by 12.7 mL/min/1.73 m² at week 12 compared to baseline (p<0.00005). Additionally, >80% of patients achieved a "clinically meaningful" improvement in eGFR of ≥3 mL/min/1.73 m² by week 8. Reata said the observed treatment effect surpassed the threshold of a 3 mL/min/1.73 m² improvement in eGFR that was required to start the Phase III portion of the trial. No serious adverse events were reported.

The double-blind, placebo-controlled Phase III portion of the trial is evaluating bardoxolone methyl for 48 weeks in about 150 patients. The Phase II primary endpoint is the change from baseline in eGFR at week 12 and the Phase III primary endpoint is the change from baseline in eGFR at week 48. Secondary endpoints include eGFR following a 4-week withdrawal period (Phase III) and safety. After the 4-week withdrawal period, patients will be restarted with their original treatment assignment and continue on-study for a second year. Final data from the Phase II portion of the trial are expected this half and data from the Phase III portion are expected in 2H19...