Bayer to present data from Phase III finerenone trials including new insights on the overlapping nature of cardio-kidney-metabolic conditions

Berlin, May 8, 2024 – Bayer will present data from both its ongoing finerenone (Kerendia™) clinical trial FINEARTS-HF in heart failure (HF) patients with a left ventricular ejection fraction (LVEF) of ≥40%, as well as from its comprehensive trial program in patients with chronic kidney disease (CKD) and type 2 diabetes (T2D) at Heart Failure 2024, a scientific congress of the European Society of Cardiology (ESC). The data will include insights around the overlapping nature of cardio-kidney-metabolic (CKM) conditions, additional risks associated with HF with LVEF ≥40% and the use of gamification to enhance clinical trial recruitment.

Finerenone FINE-HEART study design and baseline characteristics

Accepted as a late-breaker, the study design and baseline characteristics of FINE-HEART, a new pooled analysis exploring the effects of finerenone on cardio-kidney outcomes among patients with overlapping CKM conditions, will be presented. Across the ongoing FINEARTS-HF and completed FIDELIO-DKD and FIGARO-DKD trials, over 19,000 patients with CKD, T2D and/or HF are included in the analysis.

·         Design and baseline characteristics of FINE-HEART: an integrated pooled analysis of finerenone in >19,000 participants across 3 Phase III trials of HF & CKD

o   May 13, 2024; 09:06 am WEST, Room 1

Patient insights from finerenone FINEARTS-HF study

Usually, assessment of health status in HF is focused on typical symptoms such as dyspnea and fatigue. However, patients may suffer other physical and psychological consequences and associated comorbidities:

·         Pain and anxiety in heart failure – findings from FINEARTS-HF

o   May 11, 2024; 10:00 am WEST, Moderated ePosters 3

As finerenone is being studied in patients with a broad spectrum of kidney function, the range of kidney risk was examined and compared with that in the US HF population:

·         Generalizability of the FINEARTS-HF Trial to the US Population across the Spectrum of Kidney Risk

o   May 11, 2024; 10:27 am WEST, Agora 2

Although patients with HF with LVEF ≥40% commonly have CKM comorbidities, the implications of these intersections on markers of risk and health status are less well studied:

·         Cardio-Kidney-Metabolic Overlap in the FINEARTS-HF Trial

o   May 12, 2024; 01:00 pm WEST, Moderated ePosters 3

Use of gamification in FINEARTS-HF study enrollment
Multi-level challenges exist in clinical trial recruitment, leading to longer and more expensive trials. Behavioral science approaches have been shown to drive individual behavior change, however whether these strategies can be used to enhance trial enrollment is unknown:

·         A gamified behavioral science intervention to enhance trial enrollment: an embedded study within the FINEARTS-HF trial

o   May 11, 2024; 09.00 am WEST, ePosters screen 5

About Kerendia^™ / Firialta^™ (finerenone)
Kerendia™ and Firialta™ are globally protected trademarks for finerenone. Finerenone is a non-steroidal, selective mineralocorticoid receptor (MR) antagonist that has been shown to block harmful effects of MR overactivation. MR overactivation contributes to CKD progression and cardiovascular damage which can be driven by metabolic, hemodynamic, or inflammatory and fibrotic factors.

Finerenone is marketed as Kerendia™ or, in some countries, as Firialta™, and approved for the treatment of adult patients with CKD associated with T2D in more than 85 countries worldwide, including in China, Europe, Japan, and the U.S.

The study program with finerenone, FINEOVATE, currently comprises ten Phase III studies with dedicated programs in HF and CKD respectively. The THUNDERBALL CKD program consists of FIDELIO-DKD, FIGARO-DKD, FIND-CKD, FIONA, FIONA-OLE, FINE-ONE, as well as the Phase II study CONFIDENCE. The MOONRAKER program includes FINEARTS-HF, REDEFINE-HF, CONFIRMATION-HF, and FINALITY-HF.

About Chronic Kidney Disease in Type 2 Diabetes
CKD is a common and potentially deadly condition that is widely underrecognized. CKD progresses silently and unpredictably, with many symptoms not appearing until the disease is well-advanced. CKD is one of the most frequent complications arising from diabetes and is also an independent risk factor of cardiovascular disease. Up to 40% of all patients with T2D develop CKD. Despite guideline-directed therapies, patients with CKD and T2D remain at high risk of CKD progression and cardiovascular events. It is estimated that CKD affects more than 190 million people with T2D worldwide. CKD in T2D is the main cause of end stage kidney disease, which requires dialysis or a kidney transplant to stay alive. Patients with CKD and T2D are three times more likely to die from a cardiovascular-related cause than those with T2D alone.

About Heart Failure
HF is characterized by a progressive decline in the heart’s ability to pump enough blood to meet the body’s needs for blood and oxygen. HF affects more than 60 million people worldwide. This number is projected to increase drastically over the next decade, partly as a consequence of the ageing population. One in five people will develop HF. Patients with HF face a poor prognosis with mortality rates similar or worse than the most common cancers. Symptoms of HF may include dizziness, shortness of breath, fatigue, sleep disturbance, chest discomfort, edema (swelling of feet and legs), and chronic coughing or wheezing.

Risk factors include hypertension, diabetes mellitus, smoking, a past myocardial infarction, and coronary artery disease. Despite advances in treatment, around 30% of people diagnosed with HF die within one year, increasing to around 40% after five years.

When categorized by ejection fraction, which is a measure of cardiac function, HF is divided into three different categories:

• Heart failure with reduced ejection fraction (HFrEF) is characterized by the compromised ability of the heart to eject oxygen-rich blood sufficiently during its contraction phase (Left Ventricular Ejection Fraction, LVEF <40%).
• Heart failure with preserved ejection fraction (HFpEF) is a condition characterized by stiffness of the heart, leading to filling abnormalities as the left ventricle is unable to relax sufficiently to fill with blood (LVEF ≥50%).
• Heart failure with mildly reduced ejection fraction (HFmrHF) is a category for patients who fall between the two other categories (LVEF 40-49%).

While advances in therapy have been achieved in HFrEF, there are limited treatment options for HFpEF.

About Bayer’s Commitment in Cardiovascular and Kidney Diseases
Bayer is an innovation leader in the area of cardiovascular diseases, with a long-standing commitment to delivering science for a better life by advancing a portfolio of innovative treatments. The heart and the kidneys are closely linked in health and disease, and Bayer is working in a wide range of therapeutic areas on new treatment approaches for cardiovascular and kidney diseases with high unmet medical needs. The cardiology franchise at Bayer already includes a number of products and several other compounds in various stages of preclinical and clinical development. Together, these products reflect the company’s approach to research, which prioritizes targets and pathways with the potential to impact the way that cardiovascular diseases are treated.

About Bayer
Bayer is a global enterprise with core competencies in the life science fields of health care and nutrition. In line with its mission, “Health for all, Hunger for none,” the company’s products and services are designed to help people and the planet thrive by supporting efforts to master the major challenges presented by a growing and aging global population. Bayer is committed to driving sustainable development and generating a positive impact with its businesses. At the same time, the Group aims to increase its earning power and create value through innovation and growth. The Bayer brand stands for trust, reliability and quality throughout the world. In fiscal 2023, the Group employed around 100,000 people and had sales of 47.6 billion euros. R&D expenses before special items amounted to 5.8 billion euros. For more information, go to www.bayer.com.

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Forward-Looking Statements
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