Bayer announced that the Phase 3 FINEARTS-HF study, assessing the efficacy and safety of finerenone (Kerendia) in heart failure (HF) patients, has met its primary endpoint.
Finerenone is a non-steroidal, selective mineralocorticoid receptor (MR) antagonist that mitigates the detrimental effects associated with MR overactivation.
Kerendia and Firialta are registered trademarks for finerenone worldwide. It was approved by the US Food and Drug Administration (FDA) in July 2021 for chronic kidney disease (CKD) associated with type 2 diabetes.
FINEARTS-HF is a randomised, double-blind, placebo-controlled, multicentre, event-driven late-stage trial.
It assessed Kerendia in about 6,000 patients with symptomatic heart failure and a left ventricular ejection fraction (LVEF) of 40% or higher.
Patients were randomised to receive either finerenone or a placebo once daily for up to 42 months.
The primary endpoint was defined as the composite of cardiovascular death and total HF events, defined as hospitalisations for HF or urgent HF visits.
The results demonstrated that finerenone significantly and meaningfully reduced the combined risk of cardiovascular death and total HF events, which include both initial and recurrent hospitalisations or urgent visits for HF.
Finerenone was well-tolerated throughout the study, aligning with its established safety profile.
Bayer pharmaceuticals division research and development head Christian Rommel said: “We are very excited by the positive results from the FINEARTS-HF study.
“With limited options currently available for patients with this common form of heart failure with a mildly reduced or preserved ejection fraction, this news is hugely important for patients and the clinical community.
“We are looking forward to sharing the data at ESC Congress 2024, and are eager to bring finerenone to eligible patients as soon as possible.”
The FINEARTS-HF study is a component of Kerendia’s MOONRAKER programme, anticipated to be one of the largest heart failure study initiatives to date.
With over 15,000 patients enrolled, this programme aims to provide a thorough understanding of Kerendia’s effects on HF across diverse patient populations and clinical scenarios.
Bayer plans to present the data to health authorities as part of the process for submitting a marketing authorisation application.
