Bayer said it is kicking off three Phase III studies of its novel, oral, non-steroidal mineralocorticoid receptor antagonist finerenone (BAY 94-8862) in two different indications.
The German drugs giant is assessing safety and efficacy of the drug in chronic heart failure (CHF) and diabetic kidney disease (DKD), where there remains high unmet medical need, according to head of global development Joerg Moeller.
The studies are designed to investigate whether finerenone can cut cardiovascular morbidity and mortality as well as the progression of renal disease in these patients.
The FINESSE-HF trial will compare the effect of finerenone against Pfizer’s heart drug Inspra (eplerenone) in more than 3,600 CHF patients with reduced ejection fraction and type II diabetes mellitus and/or CKD across more than 35 countries including Europe, Japan, China and the US.
FIGARO-DKD will pitch finerenone against a placebo in 6,400 patients with diabetic kidney disease and high albuminuria while FIDELIO-DKD will include 4,800 patients with very high albuminuria in 40 countries across the globe.