Reata reports additional Phase II data for bardoxolone in Alport syndrome

Reata Pharmaceuticals Inc. (NASDAQ:RETA) reported additional 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) met the primary endpoint of improving mean estimated glomerular filtration rate (eGFR) at week 12 compared to baseline (p<0.000000001). Specifically, eGFR was increased by a mean of 13.4 mL/min/1.73 m^2. Patients received bardoxolone at an initial daily dose of 5 mg, which was titrated up to a goal dose of 20 or 30 mg. Data were presented at the American Society of Nephrology meeting in New Orleans. Reata previously reported interim data from the trial (see BioCentury, July 28). The company expects to report data from the Phase III portion of CARDINAL in 2H19.

Secondary endpoints include change from baseline in eGFR following a 4-week withdrawal period and safety...