Kerendia Achieves Reduction in Risk of Cardiovascular Death and Heart Failure

Bayer has shared new data from the Phase III FINEARTS-HF clinical trial, showing that its Kerendia (finerenone) achieved a statistically significant reduction of the composite of cardiovascular death and total (first and recurrent) heart failure (HF) events. The trial met its primary endpoint, making finerenone the first non-steroidal, selective mineralocorticoid receptor antagonist (MRA) to meet a primary cardiovascular endpoint in a Phase III study investigating patients with HF with mildly reduced or preserved ejection fraction.¹

In a press release, Christian Rommel, PhD, head of research and development at Bayer’s pharmaceuticals division said: “Bayer is determined to drive research and innovations that have the potential to become treatment options for diseases with high unmet medical need, including for patients with mildly reduced or preserved ejection fraction.”

The Phase III FINEARTS-HF study (NCT04435626) is a randomized, double-blind, placebo-controlled, multicenter, event-driven trial investigating the efficacy and safety of finerenone in participants with HF and left ventricular ejection fraction greater or equal to 40%.

FINEARTS-HF is part of Bayer’s MOONRAKER clinical development program. Announced in August 2023, the program is investigating finerenone as a potential treatment for HF. MOONRAKER expected to recruit approximately 15,000 patients, making it one of the largest HF study programs. Outside of FINEARTS-HF, the other studies are evaluating finerenone in HF patients with reduced (HfrEF), mildly reduced (HfmrEF), and/or preserved ejection fraction (HfpEF).²

At the time of the announcement, Michael Devoy, chief medical officer, Bayer said: “With the addition of the REDEFINE-HF, CONFIRMATION-HF, and FINALITY-HF studies to the MOONRAKER heart failure clinical trial program, we aim to gain a comprehensive understanding of the potential of finerenone for the treatment of heart failure, examining its efficacy and safety across a broad spectrum of patients and clinical settings. The studies will complement our Phase III FINEARTS-HF study, and we hope the findings will provide additional guidance around the potential clinical implementation of finerenone.”

In July 2021, finerenone received FDA approval for the treatment of patients with chronic kidney disease (CKD) associated with type 2 diabetes. The approval was based on the results of the Phase III FIDELIO-DKD trial, which demonstrated positive kidney and cardiovascular outcomes in patients with CKD associated with type 2 diabetes.³

“The patient population included in the trial that supported the approval of KERENDIA were at risk of chronic kidney disease progression despite receiving standard of care treatment to control blood pressure and blood glucose,” George Bakris, MD, University of Chicago and lead FIDELIO-DKD study investigator said in a press release. “In people with chronic kidney disease associated with type 2 diabetes, physicians now have a new treatment to provide kidney protection.”

For results of the FINEARTS-HF trial, Bayer is planning to present additional information at the European Society of Cardiology (ESC) Congress 2024 in September. The organization also plans on discussing submission for regulatory approval with the FDA.

References

1. Bayer Announces Primary Endpoint Achieved in Phase III FINEARTS-HF Cardiovascular Outcomes Study Investigating KERENDIA® (finerenone) in Patients with Heart Failure with Mildly Reduced or Preserved Ejection Fraction. News release. Bayer. August 5, 2024. Accessed August 6, 2024. https://www.businesswire.com/news/home/20240804941740/en/Bayer-Announces-Primary-Endpoint-Achieved-in-Phase-III-FINEARTS-HF-Cardiovascular-Outcomes-Study-Investigating-KERENDIA%C2%AE-finerenone-in-Patients-with-Heart-Failure-with-Mildly-Reduced-or-Preserved-Ejection-Fraction

2. Bayer Expands Clinical Development Program Investigating Finerenone for Potential Treatment of Heart Failure. News release. Bayer. August 31, 2023. Accessed August 6, 2024. https://www.businesswire.com/news/home/20230831964080/en/Bayer-Expands-Clinical-Development-Program-Investigating-Finerenone-for-Potential-Treatment-of-Heart-Failure

3. Bayer’s KERENDIA® (finerenone) Receives U.S. FDA Approval for Treatment of Patients with Chronic Kidney Disease Associated with Type 2 Diabetes. News release. Bayer. July 10, 2021. Accessed August 6, 2024. https://www.businesswire.com/news/home/20210709005441/en