Bayer HealthCare has announced the expantion of the clinical development programme for its new, oral, non-steroidal mineralocorticoid receptor antagonist (MRA) finerenone (BAY 94-8862) with three Phase III trials in patients with chronic heart failure (CHF) and with diabetic kidney disease (DKD).
First patients are expected to be enrolled by the year-end in these trials, which are designed to evaluate the efficacy and safety of finerenone.
The company noted that despite recent advances, CHF is still a deadly disease with five-years survival rates similar to those of patients with advanced cancer, while DKD is a common complication of diabetes and the most frequent cause of end-stage renal disease (ESRD) in Western countries.
Bayer HealthCare executive committee member and global development head Dr Joerg Moeller said: "The data we have seen for finerenone to date across the clinical development programme make us very confident to move finerenone forward into Phase III across two important indications of high unmet medical need.
"We are excited about finerenone being the first mineralocorticoid receptor antagonist that is being developed in parallel in chronic heart failure and diabetic kidney disease.
"The studies will investigate whether finerenone can reduce cardiovascular morbidity and mortality, as well as the progression of renal disease in these patients with a well-tolerated safety profile."
The start of the Phase III FINESSE-HF trial in CHF is based on data from the exploratory Phase IIb ARTS-HF trial, which evaluated the effects of different finerenone dosages compared to eplerenone in patients with worsening CHF with reduced ejection fraction (HFrEF) and type 2 diabetes mellitus, and / or chronic kidney disease (CKD).
In the exploratory Phase IIb ARTS-HF trial, which included a total of 1,055 patients from across 25 countries, finerenone showed a reduction of surrogate marker NT-proBNP comparable to highly effective eplerenone when comparing Day 90 to baseline.
It also showed meaningful reductions in key exploratory endpoints of all-cause death and cardiovascular hospitalisation versus eplerenone with the lowest incidence observed in the finerenone 10mg / 20 mg dose group.
The planned FINESSE-HF Phase III trial is designed to evaluate finerenone compared to eplerenone in more than 3,600 CHF patients with reduced ejection fraction and type 2 diabetes mellitus and / or CKD across more than 35 countries including Europe, Japan, China, and the US.
In this trial 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).
The Phase III programme in DKD includes two trials FIGARO-DKD and FIDELIO-DKD and are based on promising data from the Phase IIb ARTS-DN trial, which included 823 patients with type 2 diabetes and the clinical diagnosis of diabetic kidney disease from 23 countries, who were treated for 90 days.
Finerenone is a new potent and selective oral non-steroidal mineralocorticoid receptor antagonist (MRA) that blocks deleterious effects of mineralocorticoid receptor (MR) over-activation by aldosterone.