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Bayer’s Finerenone Meets Primary Endpoint in Phase III FIDELIO-DKD Renal Outcomes Study in Patients With Chronic Kidney Disease and Type 2 Diabetes

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Bayer today announced the Phase III study FIDELIO-DKD, which is evaluating the efficacy and safety of finerenone versus placebo when added to standard of care for chronic kidney disease (CKD) in patients with type 2 diabetes (T2D), has met its primary endpoint. The results show that the investigational drug finerenone delayed the progression of CKD by reducing the combined risk of time to first occurrence of kidney failure, a sustained decrease of estimated glomerular filtration rate (eGFR) greater than or equal to 40 percent from baseline over a period of at least four weeks, or renal death. Finerenone also reduced the risk of the key secondary endpoint, a composite of time to first occurrence of cardiovascular (CV) death, non-fatal myocardial infarction, non-fatal stroke, or heart failure hospitalization. The clinical data from FIDELIO-DKD will be presented at an upcoming scientific meeting.

The FIDELIO-DKD study is part of the largest Phase III clinical trial program to date in CKD, which enrolled 13,000 patients across a broad range of disease severity, including those with early kidney damage and more advanced stages of kidney disease. FIDELIO-DKD is a randomized, double-blind, placebo-controlled, parallel-group, multicenter, event-driven Phase III study investigating finerenone versus placebo in patients with CKD and T2D. The study included approximately 5,700 patients from more than 1,000 sites across 48 countries worldwide. Patients were randomized to receive either finerenone 10 mg or 20 mg orally once daily or placebo when added to standard of care, including blood glucose lowering therapies and maximum tolerated dose of renin“angiotensin system (RAS)-blocking therapy, such as angiotensin-converting enzyme (ACE) inhibitors or angiotensin II receptor blockers (ARBs).

There has been a recent uptick of both federal initiatives and public-private partnerships encouraging innovation to improve kidney health in America. In 2019, the United States (U.S.) Department of Health and Human Services announced Advancing American Kidney Health, an executive order focused on improving the prevention, detection and treatment of kidney disease.3

About Finerenone

Finerenone (BAY 94-8862) is an investigational, non-steroidal, selective mineralocorticoid receptor antagonist (MRA) that has been shown to reduce the harmful effects of mineralocorticoid receptor (MR) overactivation.4 Mineralocorticoid receptor overactivation is a major driver of kidney and heart damage.

The finerenone Phase III clinical program is comprised of two studies which randomized more than 13,000 patients with CKD and T2D from around the world to evaluate the effect of finerenone versus placebo on top of standard of care on both renal and CV outcomes. FIDELIO-DKD (FInerenone in reducing kiDnEy faiLure and dIsease prOgression in Diabetic Kidney Disease) investigated the efficacy and safety of finerenone in comparison to placebo in addition to standard of care on the reduction of kidney failure and kidney disease progression in approximately 5,700 patients with CKD and T2D. The study has met its primary efficacy endpoint. FIGARO-DKD (FInerenone in reducinG cArdiovascular moRtality and mOrbidity in Diabetic Kidney Disease) is still ongoing and is investigating the efficacy and safety of finerenone versus placebo in addition to standard of care on the reduction of CV morbidity and mortality in approximately 7,400 patients with CKD and T2D across 48 countries including sites in Europe, Japan, China and the U.S. In 2015, the U.S. Food and Drug Administration granted Fast Track designation for finerenone.

Bayer also recently announced the initiation of the FINEARTS-HF study, a multicenter, randomized, double-blind, placebo-controlled Phase III study which will investigate finerenone compared to placebo in more than 5,500 symptomatic heart failure patients (New York Heart Association class II-IV) with a left ventricular ejection fraction of greater than or equal to 40 percent. The primary objective of the study is to demonstrate superiority of finerenone over placebo in reducing the rate of the composite endpoint of CV death and total (first and recurrent) heart failure (HF) events (defined as hospitalizations for HF or urgent HF visits).

About Chronic Kidney Disease in Type 2 Diabetes

Chronic kidney disease is one of the most frequent complications arising from diabetes and is also an independent risk factor of CV.5 Approximately 40 percent of all patients with T2D develop CKD.2 Chronic kidney disease in T2D is the main cause of end stage kidney disease and kidney failure and at advanced stages, patients may need dialysis or a kidney transplant to stay alive.6,7 Over a 10-year period, patients with CKD in T2D were three times more likely to die of CV-related causes than patients with T2D alone.8 Mineralocorticoid receptor over-activation is known to trigger detrimental processes (e.g., inflammation and fibrosis) in the kidneys and heart in patients with CKD and T2D.9 Chronic kidney disease in T2D is the most common cause of kidney failure worldwide.10

About Cardiology at Bayer

Bayer is an innovation leader globally in the area of CV 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 CV and kidney diseases with high unmet medical needs. The cardiology franchise at Bayer includes several compounds in various stages of preclinical and clinical development. Together, these products reflect the companys approach to research, which prioritizes targets and pathways with the potential to impact the way that CV diseases are treated.

About Bayer

Bayer is a global enterprise with core competencies in the life science fields of health care and nutrition. Its products and services are designed to benefit people by supporting efforts to overcome the major challenges presented by a growing and aging global population. At the same time, the Group aims to increase its earning power and create value through innovation and growth. Bayer is committed to the principles of sustainable development, and the Bayer brand stands for trust, reliability and quality throughout the world. In fiscal 2019, the Group employed around 104,000 people and had sales of 43.5 billion euros. Capital expenditures amounted to 2.9 billion euros, R&D expenses to 5.3 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 Bayers 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.

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1 American Diabetes Association. Statistics about diabetes. Accessed October 3, 2019. https://www.diabetes.org/resources/statistics/statistics-about-diabetes

2 International Diabetes Foundation. IDF diabetes atlas 8th edition 2017. Accessed January 13, 2020. https://www.diabetesatlas.org/en/

3 U.S Department of Health and Human Services. Advancing American kidney health. 2019; 1-31.

4 Kolkhof et al. Steroidal and novel non-steroidal mineralocorticoid receptor antagonists in heart failure and cardiorenal diseases: comparison at bench and bedside. Heart Failure, Handbook of Experimental Pharmacology. 2017; 243: 285-287.

5 Alicic et al. Diabetic kidney disease challenges, progress, and possibilities. Clin J Am Soc Nephrol. 2017; 12: 2032-2045.

6 Doshi S and Friedman A. Diagnosis and management of type 2 diabetic kidney disease. Clin J Am Soc Nephrol. 2017; 12: 1366-1373.

7 Mayo Clinic. Chronic kidney disease diagnosis and treatment. Accessed May 4, 2019. https://www.mayoclinic.org/diseases-conditions/chronic-kidney-disease/diagnosis-treatment/drc-20354527

8 Afkarian M, Sachs MC and Kestenbaum B, et al. J Am Soc Nephrol. 2013;24(2):302“308.

9 Belden et al. The role of the mineralocorticoid receptor in inflammation: focus on kidney and vasculature. Am J Nephrol. 2017; 46(4): 298314.

10 National Kidney Foundation. Diabetes and chronic kidney disease. Accessed June 26, 2020. https://www.kidney.org/news/newsroom/factsheets/Diabetes-And-CKD

Media:

David Patti, +1-973-452-6793

Bayer, U.S. Corporate Communications

[email protected]