Finerenone is an investigational non-steroidal, selective mineralocorticoid receptor (MR) antagonist, which prevents kidney and cardiovascular damage
Bayer Pharmaceuticals headquarters in Berlin-Wedding. (Credit: Fridolin freudenfett/Wikipedia.)
German life sciences firm Bayer announced that the investigational drug finerenone slowed the progression of chronic kidney disease (CKD) in patients suffering with CKD and type 2 diabetes (T2D) compared to placebo in the Phase 3 FIDELIO-DKD study.
Finerenone is an investigational non-steroidal, selective mineralocorticoid receptor (MR) antagonist, which blocks various harmful effects of mineralocorticoid receptor (MR) overactivation that causes kidney and cardiovascular damage.
FIDELIO-DKD (FInerenone in reducing kiDnEy faiLure and dIsease prOgression in Diabetic Kidney Disease) is a randomised, double-blind, placebo-controlled, parallel-group, multicentre Phase 3 study evaluating finerenone for reducing kidney failure and progression of kidney disease in 5,700 CKD and T2D patients at 1,000 sites across 48 countries.
Details of the trial
The trial indicated that the impact of finerenone on the primary outcome were generally consistent across pre-specified subgroups, and the treatment effect was found to have sustained throughout the duration of the trial.
Finerenone also found to have significantly cut down the risk of the important secondary endpoint, a composite of time to cardiovascular death, non-fatal myocardial infarction, non-fatal stroke or hospitalization for heart failure compared to placebo by 14% over a median duration of follow-up of 2.6 years.
During the trial, patients in both the groups received standard of care, including blood glucose lowering therapies and a maximum tolerated dose of a renin-angiotensin system (RAS)-blocking therapy such as an angiotensin-converting enzyme (ACE) inhibitor or an angiotensin II receptor blocker (ARB).
Bayer AG’s member of the executive committee of pharmaceutical division and head of research and development Dr. Joerg Moeller said: “These vulnerable patients need to be protected by delaying the need for dialysis or a kidney transplant, and to reduce their risk of cardiovascular events.
“There is a high unmet medical need in cardiovascular and kidney diseases, which we aim to address with our research and development efforts. The FIDELIO-DKD results demonstrate that finerenone may become a new potential therapeutic option for patients with chronic kidney disease and type 2 diabetes, who experience progressive loss of kidney function.
“We are pleased to have reached this important development milestone for finerenone that addresses a key driver involved in the progression of chronic kidney disease in type 2 diabetes.”
Furthermore, Bayer intends to begin FINEARTS-HF study, a multicentre, randomised, double-blind, placebo-controlled Phase 3 study to evaluate finerenone versus placebo in 5,500 subjects with symptomatic heart failure with a left ventricular ejection fraction.