Bayer’s finerenone hits primary endpoint in Phase III heart failure trial
Bayer’s finerenone hits primary endpoint in Phase III heart failure trial
Bayer said Monday its Phase III cardiovascular outcomes trial hit the primary endpoint, positioning the company to discuss with regulators filing for approval of finerenone in heart failure.
The FDA approved finerenone in adults with chronic kidney disease associated with type 2 diabetes in 2021. Bayer, which sells the drug as Kerendia in the kidney indication, also identified the potential for the non-steroidal, selective mineralocorticoid receptor antagonist to improve outcomes in people with heart failure with mildly reduced or preserved ejection fraction.
Bayer put that idea to the test in the FINEARTS-HF study. Investigators randomized around 6,000 people with symptomatic heart failure to take finerenone or placebo once a day for up to 42 months. Monday, Bayer said finerenone significantly reduced the composite of cardiovascular death and total heart failure events compared to placebo.
The significant reduction caused the trial to hit its primary endpoint. Bayer is yet to share data from the study but is sufficiently encouraged by the results to outline plans to talk to regulatory agencies about filing for approval.
Finerenone was well tolerated in the study, according to Bayer. While the company did not share data on safety and tolerability, the positive topline finding is encouraging for a molecule with a mechanism of action that has proven problematic in the past.
Mineralocorticoid receptor antagonists such as spironolactone and eplerenone are used to treat heart failure with reduced ejection fraction. In that population, the drugs have improved outcomes in clinical trials. However, spironolactone was less impressive in a trial in heart failure with preserved ejection fraction, failing to reduce cardiovascular mortality while raising the risk of elevated potassium levels.
Bayer’s trial program, which has enrolled more than 15,000 patients, and real-world finerenone use in kidney disease patients suggest the risk of elevated potassium levels may be lower for its molecule. The combination of improved cardiovascular outcomes and acceptable tolerability underpins Bayer’s hopes of turning finerenone into a blockbuster.
