Bayer to present real-world study data of Kerendia™ (finerenone) use and risk models for the progression of chronic kidney disease and onset of hyperkalaemia

Berlin, May 23, 2024 – Bayer will present data on Kerendia™ (finerenone) use among patients with chronic kidney disease (CKD) and type 2 diabetes (T2D) in real-world clinical practice, as well as new risk models for patients with CKD and T2D at the 61^st European Renal Association (ERA) Congress. The data will include insights on how finerenone is used with other renal and cardiovascular protective medicines, and modelling with the aim to predict the long-term risk of CKD and potential onset of hyperkalaemia.

Risk model for CKD progression

Accepted as a focused oral presentation, the study tests a new model using patient data from the FIDELITY pooled analysis. Developed by the CKD Prognosis Consortium (CKD-PC), it aims to predict the 3-year risk of a ≥40% decrease in estimated glomerular filtration rate (eGFR) or kidney failure in the general population:

• CKD-PC risk model for CKD Progression: Validation and association with outcomes in the FIDELITY population

o   May 24, 2024; 17:40 CEST, Focused Oral Room 8

Risk model for hyperkalaemia

Despite the positive data for use of finerenone among patients with CKD and T2D, perceived risk of hyperkalaemia may limit use, particularly in patients with high risk of increased serum potassium. A new risk score model was developed and validated using data from the FIDELITY analysis, and the efficacy of finerenone was also assessed among patients with differing levels of hyperkalaemia risk. The study was accepted as a late-breaker:

• Hyperkalemia risk and the effect of finerenone in patients with diabetes and chronic kidney disease: an analysis from FIDELITY

o   May 24, 2024; 16:15 CEST, The Square

Real-world clinical outcomes for finerenone

Building on clinical trial data demonstrating ability of finerenone to reduce the risk of cardiovascular and renal complications, real-world study data was obtained from US patients with CKD and T2D. The analysis of 28,056 health records and insurance claims is part of a multi-national, multi-database observational research platform:

• Clinical outcomes in US patients initiating finerenone – a report from the FOUNTAIN platform

o   May 23, 2024; 00:51 CEST, e-Poster

About the FIDELITY analysis
FIDELITY is a prespecified pooled analysis of more than 13,000 patients from the Phase III studies FIGARO-DKD and FIDELIO-DKD, investigating the efficacy and safety of finerenone across the spectrum of patients with CKD in T2D.

About Kerendia^™ (finerenone) / 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 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
This release may contain forward-looking statements based on current assumptions and forecasts made by Bayer management. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, development or performance of the company and the estimates given here. These factors include those discussed in Bayer’s public reports which are available on the Bayer website at www.bayer.com. The company assumes no liability whatsoever to update these forward-looking statements or to conform them to future events or developments.