Bayer expands BAY 94-8862 (finerenone) Phase III programme in heart failure and diabetic kidney disease

Bayer HealthCare announced the expansion of the clinical development programme for its novel oral non-steroidal mineralocorticoid receptor antagonist (MRA) finerenone (BAY 94-8862) with three Phase III studies. The studies will investigate the efficacy and safety of finerenone in patients with chronic heart failure (CHF) and patients with diabetic kidney disease (DKD) with the first patients expected to be enrolled by the year-end. Despite recent advances, chronic heart failure is still a deadly disease with 5-year survival rates similar to those of patients with advanced cancer. Diabetic kidney disease is a common complication of diabetes and the most frequent cause of end-stage renal disease (ESRD) in Western countries. Diabetes causes more than 40 per cent of new cases of ESRD.

The planned Phase III study FINESSE-HF will investigate finerenone compared to eplerenone in chronic heart failure patients with reduced ejection fraction and type 2 diabetes mellitus and/or chronic kidney disease across more than 35 countries, including Europe, Japan, China and the US. Patients will receive finerenone or eplerenone on top of standard medical treatment currently represented by angiotensin converting enzyme (ACE) inhibitors or angiotensin receptor blocker (ARBs) and β-blockers.

The Phase III programme in DKD comprises two studies. FIGARO-DKD will investigate finerenone versus placebo in 6,400 patients with the clinical diagnosis of diabetic kidney disease mainly comprising of patients with high albuminuria (previously known as 'micro-albuminuria'), while FIDELIO-DKD will investigate finerenone in comparison to placebo in 4,800 patients with the clinical diagnosis of diabetic kidney disease mainly comprising of patients with very high albuminuria (previously known as 'macro-albuminuria'). Both studies will be conducted in about 40 countries including Europe, Japan, China and the USA. Patients will receive finerenone or placebo on top of current standard of care, which includes RAS-blocking therapy such as ACE inhibitors or ARBs.