Bayer reveals positive phase 3 results for Kerendia in heart failure study

Bayer has announced encouraging outcomes from a late-stage clinical trial involving Kerendia (finerenone) for heart failure (HF) patients with mildly reduced or preserved ejection fraction. Kerendia, a non-steroidal mineralocorticoid receptor antagonist, is already approved for reducing the risk of cardiovascular death, non-fatal myocardial infarction, hospitalizations for heart failure, sustained decline in estimated glomerular filtration rate (eGFR), and end-stage kidney disease in adults with chronic kidney disease (CKD) linked to type 2 diabetes.

The FINEARTS-HF phase 3 trial has been assessing the effectiveness of Kerendia in roughly 6,000 patients diagnosed with symptomatic heart failure, having a left ventricular ejection fraction (LVEF) of at least 40%. Participants were randomly assigned to receive either Kerendia or a placebo once daily for up to 42 months. In the United States, around 55% of the 6.7 million adults with heart failure exhibit an LVEF of at least 40%. Despite the significant prevalence, treatment options for this group are limited.

These patients often also grapple with multiple co-morbidities, such as obesity, hypertension, and chronic kidney disease, which complicate treatment decisions for healthcare professionals. The FINEARTS-HF study achieved its primary goal, showing a statistically significant reduction in the composite measure of cardiovascular death and total heart failure events, which included hospitalizations and urgent visits for heart failure. Importantly, no new safety concerns were identified, in line with previous studies of the drug.

Bayer has indicated plans to present the findings at the European Society of Cardiology Congress this September and to discuss regulatory approval with the U.S. Food and Drug Administration. Dr. Christian Rommel, head of research and development at Bayer’s pharmaceuticals division, stated that the company is committed to advancing research and innovations that could become treatment options for diseases with substantial unmet medical needs, particularly for patients with mildly reduced or preserved ejection fraction.

These positive results come shortly after Bayer and Orion reported significant survival benefits from their drug darolutamide in a phase 3 trial for metastatic hormone-sensitive prostate cancer. The ARANOTE trial demonstrated that darolutamide, combined with androgen deprivation therapy (ADT), significantly increased radiological progression-free survival compared to a placebo plus ADT.