Bayer Reports Positive Kerendia Results in Late-Stage Heart Failure Study

Bayer has revealed detailed outcomes from a significant late-stage study assessing Kerendia (finerenone) for treating heart failure (HF) patients with mildly reduced or preserved ejection fraction. This phase 3 clinical trial, named FINEARTS-HF, involved 6,000 participants. It compared the efficacy of the non-steroidal mineralocorticoid receptor antagonist against a placebo, both administered alongside the patients' standard treatment regimens. The study focused on individuals diagnosed with symptomatic HF, who had a left ventricular ejection fraction (LVEF) of at least 40%, over a period of up to 42 months.

The findings, presented at the European Society of Cardiology Congress and published in The New England Journal of Medicine, demonstrated that Kerendia lowered the risk of the composite primary endpoint, which includes cardiovascular death and total HF events. These events are defined as unplanned hospitalizations for HF or urgent HF visits. Compared to the placebo, Kerendia showed a 16% reduction in these risks.

Moreover, the primary endpoint results were consistent across all pre-specified subgroups. Importantly, no new safety concerns emerged compared to those identified in earlier studies of the drug, as per Bayer's reports. 

In the United States, approximately 55% of the 6.7 million adults with HF have an LVEF of at least 40%. Despite the high prevalence, there are limited guideline-directed medical treatment options available for this population. Additionally, these patients often suffer from multiple co-morbidities such as obesity, hypertension, and chronic kidney disease (CKD), which complicates treatment decisions for healthcare providers.

Christian Rommel, head of research and development at Bayer's pharmaceuticals division, emphasized the company's commitment to addressing this severe condition. He stated that the FINEARTS-HF results underscore Kerendia's potential to reduce cardiovascular risks in a patient population that is particularly challenging to treat.

Kerendia is already approved for reducing the risk of cardiovascular death, non-fatal myocardial infarction, hospitalization for HF, sustained decline in estimated glomerular filtration rate (eGFR), and end-stage kidney disease in adults with CKD linked to type 2 diabetes. Based on the new data, Bayer plans to engage in discussions with the US Food and Drug Administration regarding regulatory approval.

These promising results come shortly after Bayer announced a partnership with NextRNA Therapeutics. The collaboration, valued at $547 million, aims to develop small molecule therapeutics targeting a new class of entities in oncology.

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