Clinical Data
The ADPKD cohort of PHOENIX enrolled 31 patients, and available data demonstrate that bardoxolone methyl (bardoxolone) significantly improved kidney function in ADPKD patients as measured by their estimated glomerular filtration rate (eGFR). Bardoxolone-treated patients showed a mean improvement of 6.6 mL/min/1.73 m2 at Week 4 (n=31; p<0.0001), increasing to 12.0 mL/min/1.73 m2 at Week 12 (n=8; p<0.0001) from a mean baseline eGFR of 47.7 mL/min/1.73 m2. The IgA nephropathy cohort enrolled 26 patients, and data were reported through Week 8. Bardoxolone-treated patients showed a mean improvement of 8.4 mL/min/1.73 m2 at Week 8 (n=9; p<0.0001) from a mean baseline eGFR of 46.2 mL/min/1.73 m2. No drug-related serious adverse events have been reported, and reported adverse events have generally been mild to moderate in intensity. Full data for the primary endpoint of change in eGFR at Week 12 for the ADPKD, IgA nephropathy, and type 1 diabetic chronic kidney disease (CKD) cohorts of PHOENIX will be available in the third quarter of 2018.