Bayer announced today that the FINEARTS-HF trial met its primary endpoint by achieving a statistically significant reduction in the composite of cardiovascular death and total (first and recurrent) heart failure (HF) events, including hospitalizations for HF or urgent HF visits. This randomized, double-blind, placebo-controlled, multi-center Phase III cardiovascular outcomes study evaluated the efficacy and safety of KERENDIA® (finerenone) in patients with HF with a left ventricular ejection fraction (LVEF) ≥ 40%, which measures how much blood the heart pumps with each beat. No new safety signals were identified compared to previous studies with the compound.
KERENDIA is already approved to reduce the risk of cardiovascular death, non-fatal myocardial infarction, hospitalization for heart failure, sustained eGFR decline, and end-stage kidney disease in adults with chronic kidney disease (CKD) associated with type 2 diabetes (T2D). As a non-steroidal, selective mineralocorticoid receptor antagonist (MRA), KERENDIA has demonstrated cardiovascular benefits in adults with CKD in T2D, and the new data shows positive results in heart failure patients with LVEF > 40%.
Bayer will present the FINEARTS-HF data at the European Society of Cardiology (ESC) Congress 2024 in September and plans to discuss regulatory approval with the U.S. Food and Drug Administration (FDA).
The FINEARTS-HF study is part of KERENDIA’s MOONRAKER program, which is expected to be one of the largest HF study programs to date with over 15,000 patients. This program aims to establish a comprehensive understanding of KERENDIA in heart failure across a broad spectrum of patients and clinical settings.
Heart failure is a complex condition affecting approximately 6.7 million adults in the U.S., with about 55% having an LVEF ≥ 40%. Despite the high prevalence, treatment options for this group are limited. These patients often manage multiple comorbidities, such as obesity, hypertension, and CKD, adding complexity to their treatment.
“Bayer is committed to driving research and innovations that can address diseases with high unmet medical needs, including heart failure with mildly reduced or preserved ejection fraction,” said Dr. Christian Rommel, Head of Research and Development at Bayer’s Pharmaceuticals Division.
About FINEARTS-HF
FINEARTS-HF is a randomized, double-blind, placebo-controlled, multicenter Phase III study investigating the efficacy and safety of KERENDIA (finerenone) in reducing the risk of cardiovascular death and HF events in symptomatic heart failure patients (NYHA class II-IV) with an LVEF ≥ 40%, confirmed by local imaging within the last 12 months and on diuretic treatment for at least 30 days before randomization. The primary endpoint was the composite of cardiovascular death and total HF events (hospitalizations or urgent visits).
Approximately 6,000 patients were randomized to receive either finerenone or placebo once daily for up to 42 months.
With more than 15,000 patients overall, the MOONRAKER clinical trial program, including FINEARTS-HF, aims to build extensive evidence for finerenone across diverse patient populations and clinical settings.
