Reata Pharmaceuticals reports 'positive' results from FSGS cohort of PHOENIX
Reata Pharmaceuticals announced positive, final results from the focal segmental glomerulosclerosis cohort of PHOENIX, a Phase 2 study of bardoxolone methyl in patients with rare forms of chronic kidney disease. Compared to baseline, bardoxolone significantly improved kidney function as measured by patients' estimated glomerular filtration rate at Week 12, which was the primary endpoint of the PHOENIX study. Patients treated with bardoxolone experienced a significant increase in eGFR of 7.8 mL/min/1.73 m2 at Week 12 compared to baseline. Reata collected historical eGFR data for 17 of the 18 patients, which demonstrated that these patients' kidney function was declining at an average annual rate of 2.6 mL/min/1.73 m2 prior to study entry. The observed 7.8 mL/min/1.73 m2 improvement after 12 weeks of treatment with bardoxolone represents a recovery of three years of average eGFR loss. With respect to safety, no treatment-related serious adverse events were reported, and the reported adverse events were generally mild to moderate in intensity. Overall, the PHOENIX trial studied 103 patients who had one of four rare forms of CKD, including autosomal dominant polycystic kidney disease, IgA nephropathy, type 1 diabetic CKD, and FSGS. Historical eGFR data collected from 91 of the 103 patients demonstrated that these patients' kidney function was declining at an average annual rate of 2.8 mL/min/1.73 m2 prior to study entry. After 12 weeks of once-daily, oral administration of bardoxolone, the mean change in eGFR from baseline across all four cohorts was 7.8 mL/min/1.73 m2. Notably, 88% of patients who reached Week 12 demonstrated an improvement in eGFR. Bardoxolone significantly reduced mean systolic blood pressure by 3.8 mmHg and mean diastolic blood pressure by 2.8 mmHg. Urinary albumin excretion was low upon study entry and remained unchanged by bardoxolone treatment. Bardoxolone was well-tolerated, with 89% of patients in PHOENIX completing treatment through Week 12, and no treatment-related serious adverse events were reported.