Bayer to Present KERENDIA® (finerenone) Trial Data at Heart Failure 2024 Congress

Bayer is set to present new data on Kerendia® (finerenone) at the Heart Failure 2024 conference organized by the European Society of Cardiology (ESC), scheduled for May 11-14, 2024, in Lisbon, Portugal. The company will unveil findings from its expansive clinical trial program targeting patients with chronic kidney disease (CKD) and type 2 diabetes (T2D), alongside data from the ongoing FINEARTS-HF study.

Kerendia®, a non-steroidal mineralocorticoid receptor antagonist (MRA), has been approved in over 70 countries, including the United States, for treating adults with CKD linked to T2D. The Heart Failure 2024 conference will feature a pre-specified pooled analysis of three Phase III trials under the FINE-HEART initiative. This analysis will shed light on the effects of finerenone on cardio-kidney outcomes among specific patient subgroups, with a focus on heart failure (HF) patients having a left ventricular ejection fraction (LVEF) of 40% or higher.

The FINE-HEART study aims to provide insights into the interconnectedness of cardio-kidney-metabolic (CKM) conditions and additional risks associated with HF with LVEF ≥40%. Gamification techniques to enhance patient enrollment in clinical trials will also be discussed, specifically in the context of the FINEARTS-HF study.

The FINEARTS-HF trial is a large-scale, randomized, double-blind, placebo-controlled, multicenter study investigating the efficacy and safety of finerenone in patients with symptomatic HF and an LVEF of 40% or higher. The trial will assess endpoints such as cardiovascular death and total heart failure events. Kerendia® has been studied extensively in the FIDELIO-DKD and FIGARO-DKD trials, which encompass a wide range of CKD severity in adults with CKD related to T2D. These trials have demonstrated that Kerendia® significantly reduces the risk of CKD and cardiovascular events. Consequently, Kerendia® has been endorsed by several major treatment guidelines, including those from the American Diabetes Association® (ADA) and the Kidney Disease: Improving Global Outcomes® (KDIGO) Foundation.

Heart failure is a prevalent chronic condition affecting approximately 6.5 million adults in the United States. It is characterized by a progressive decline in the heart's ability to pump enough blood to meet the body's needs. Common symptoms include shortness of breath, fatigue, chest discomfort, and lower body swelling. Risk factors for heart failure include hypertension, diabetes mellitus, smoking, a history of myocardial infarction, and coronary artery disease. Patients with diabetes are at a higher risk of developing heart failure and tend to have worse cardiovascular outcomes and prognosis compared to those without diabetes. Studies indicate that 44% of patients hospitalized for heart failure have diabetes.

Bayer's commitment to cardiovascular and kidney diseases is longstanding. The company is engaged in numerous preclinical and clinical development projects aimed at addressing high unmet medical needs in these areas. Bayer's cardiorenal franchise includes a range of products and compounds that could significantly impact the treatment of cardiovascular and kidney diseases.

Bayer remains dedicated to advancing research and treatment options for these conditions. The company actively collaborates with various groups and institutions to improve health outcomes, promote health literacy and education, and support research initiatives that address diverse patient needs. This commitment is aligned with Bayer’s mission of delivering science for a better life and driving sustainable development.

In summary, Bayer’s upcoming presentations at the Heart Failure 2024 conference will provide valuable insights into the efficacy and safety of Kerendia® for treating CKD associated with T2D and heart failure. The data from the FINE-HEART and FINEARTS-HF trials will contribute to a deeper understanding of cardio-kidney-metabolic conditions and may enhance clinical trial recruitment through innovative approaches like gamification. Bayer continues to lead in the cardiovascular and kidney disease space, striving to improve patient outcomes through rigorous scientific research and development.