Reata Pharmaceuticals has reported that its study that shows bardoxolone methyl can improve kidney functions for patients with pulmonary arterial hypertension.
Reata on Friday announced the results from the long-term follow up portion of the LARIAT study. The two-year duration of sustained eGFR improvement in LARIAT is twice as long as Reata has previously reported for bardoxolone and supports the rationale for Reata’s ongoing CARDINAL and PHOENIX programs in rare forms of chronic kidney disease (CKD), the company said.
“Treatments for PAH improve symptoms but often worsen kidney function, placing patients at greater risk,” said Daniel W. Coyne, M.D., Nephrologist and Professor of Medicine at Washington University in St. Louis, Missouri. “The two-year trial data are the longest available with bardoxolone and suggest raising kidney function with bardoxolone is not harmful and is likely to be beneficial in PAH patients and other disease states,” he said.
Reata said that the two-year eGFR data from LARIAT extend earlier observations that bardoxolone treatment is associated with preservation of kidney function. Furthermore, recently published data from Reata’s diabetic CKD trials (BEAM and BEACON) demonstrated that eGFR improvements from bardoxolone treatment were durable for at least one year and associated with a more than 50% reduced likelihood of adverse renal events validated to predict kidney failure. The company has pointed out that these data demonstrated that patients treated with bardoxolone for at least one year had a persisting improvement in kidney function versus placebo even after the drug was withdrawn for one month.
Reata’s Chief Medical Officer, Colin Meyer, said the analyses of long-term clinical data has helped differentiate the improvements in kidney function with bardoxolone from agents that may modestly, transiently, and adversely increase kidney function by increasing blood pressure in the kidney. He said that the longer term data in PAH patients, who are extremely sensitive to any adverse perturbations of renal or cardiac function, provides further evidence that bardoxolone may be beneficial, and not harmful, to the kidney.