Reata Pharmaceuticals announced 'positive', final results from the IgA nephropathy and type 1 diabetic chronic kidney disease, or T1D CKD, cohorts of PHOENIX, a Phase 2 study of bardoxolone methyl in patients with rare forms of CKD. Compared to baseline, bardoxolone significantly improved kidney function as measured by patients' estimated glomerular filtration rate, or eGFR, at week 12 in both cohorts, which was the primary endpoint of the PHOENIX study. In the IgA nephropathy cohort of PHOENIX, patients treated with bardoxolone experienced a significant increase in eGFR of 8.0 mL/min/1.73 m2 at week 12 compared to baseline. Reata collected historical eGFR data for 23 of these patients, which demonstrated that these patients' kidney function was declining at an average annual rate of 1.2 mL/min/1.73 m2 prior to study entry. The observed 8.0 mL/min/1.73 m2 improvement after 12 weeks of treatment with bardoxolone represents a recovery of approximately six years of average eGFR loss. In the T1D CKD cohort of PHOENIX, patients treated with bardoxolone experienced a significant increase in eGFR of 5.5 mL/min/1.73 m2 at week 12 compared to baseline. Reata collected historical eGFR data for 22 of these patients, which demonstrated that these patients' kidney function was declining at an average annual rate of 1.9 mL/min/1.73 m2 prior to study entry. The observed 5.5 mL/min/1.73 m2 improvement after 12 weeks of treatment with bardoxolone represents a recovery of approximately three years of average eGFR loss. With respect to safety, no treatment-related serious adverse events were reported in either cohort, and the reported adverse events were generally mild to moderate in intensity.
