The company claims that finerenone is the first investigational non-steroidal, selective mineralocorticoid receptor antagonist to show renal and cardiovascular benefits in patients with chronic kidney disease and type 2 diabetes
Bayer announced that the Phase III study FIDELIO-DKD, which is evaluating the efficacy and safety of finerenone versus placebo when added to standard of care for chronic kidney disease or CKD in patients with type 2 diabetes or T2D, has met its primary endpoint.
Finerenone is the first investigational non-steroidal, selective mineralocorticoid receptor antagonist to show renal and cardiovascular benefits in patients with chronic kidney disease and type 2 diabetes, according to the firm.
The results show that the investigational drug finerenone delayed the progression of CKD by reducing the combined risk of time to the first occurrence of kidney failure, a sustained decrease of estimated glomerular filtration rate or eGFR greater than or equal to 40 per cent from baseline over a period of at least four weeks, or renal death.
Finerenone also reduced the risk of the key secondary endpoint, a composite of time to the first occurrence of cardiovascular death, non-fatal myocardial infarction, non-fatal stroke, or heart failure hospitalisation.
Bayer said it will discuss the data with health authorities with a view to submitting a marketing application in this setting.