Data from Pharmawand - Curated by EPG Health - Date added 26 July 2018
Reata Pharmaceuticals, Inc. announced results from two Phase II studies of bardoxolone methyl (bardoxolone) in patients with chronic kidney disease (CKD)>. Reata reported positive one-year results for the Phase II portion of CARDINAL, a study of bardoxolone in patients with CKD due to Alport syndrome, and positive final results for the Phase II autosomal dominant polycystic kidney disease (ADPKD) cohort of PHOENIX.
In the Phase II portion of CARDINAL, significantly increased estimated glomerular filtration rate (eGFR) at Week 48 from baseline (n=25) of 10.4 mL/min/1.73 m2 (p<0.0001) was observed in patients treated with bardoxolone. Reata collected historical eGFR data for 22 out of the 25 Phase II study subjects. The historical eGFR data demonstrate that the Phase II study subjects’ kidney function was declining at an average annual rate of 4.2 mL/min/1.73 m2 prior to study entry. The observed 10.4 mL/min/1.73 m2 improvement after one year of treatment with bardoxolone represents a recovery of approximately two years of average eGFR loss. Significantly increased eGFR from baseline at Week 52 after withdrawal of active drug for four weeks (the retained eGFR benefit) by a mean of 4.1 mL/min/1.73 m2 (p<0.05) was also observed with bardoxolone treated patients. These results provide evidence that bardoxolone may delay or prevent kidney failure. The FDA has provided Reata with guidance that, in Alport syndrome patients, a significant improvementin placebo-corrected retained eGFR after one year of bardoxolone treatment may support accelerated approval and, after two years of bardoxolone treatment, may support full approval.
With respect to safety in the Phase II portion of CARDINAL, no treatment-related serious adverse events have been reported, and the reported adverse events have generally been mild to moderate in intensity. Twenty-five patients were available for the analysis, and no discontinuations were due to bardoxolone treatment.
Analysts from Jefferies, an investment firm, believe Phase III data sufficient for accelerated approval of bardoxolone in Alport syndrome could be available by the second half of 2019..