Bayer’s Finerenone Meets Major Endpoint in Section III FIGARO-DKD Cardiovascular Outcomes Research in Sufferers With Power Kidney Illness and Sort 2 Diabetes

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WHIPPANY, NJ – (BUSINESS WIRE) – Bayer’s phase III cardiovascular outcome study FIGARO-DKD evaluating the efficacy and safety of the investigational drug finerenone versus placebo when it becomes standard in patients with chronic kidney disease (CKD) and type 2 diabetes (T2D) added to care has met its requirements Primary endpoint. The study showed that finerenone significantly reduced the composite risk of time to first onset of cardiovascular death (CV) or non-fatal CV events (myocardial infarction, stroke, or hospitalization for heart failure). The Phase III FIGARO DKD study included more patients with early-stage CKD and T2D than the FIDELIO-DKD study, which was the first of two Phase III studies that included finerenone in patients with CKD and T2D.1 , 3 was examined

“Up to 40 percent of people with type 2 diabetes develop chronic kidney disease and are at high risk of cardiovascular events and kidney failure,” said Prof. Luis M. Ruilope, professor in the Department of Public Health and Preventive Medicine from Autonoma University and Co-Principal Investigator of the FIGARO-DKD study. “The FIGARO-DKD study provides important insight into the potential effects of finerenone on cardiovascular outcomes in the treatment of people with chronic kidney disease and type 2 diabetes.”

“With the positive result of the composite primary endpoint of the FIGARO-DKD study, we have reached a significant milestone for finerenone by completing the largest phase III clinical study program to date, focusing on chronic kidney disease and type 2 diabetes in a wide range of studies focused on disease severity, “said Dr. Christian Rommel, member of the Executive Committee of the Pharmaceutical Department of Bayer AG and Head of Research and Development. “We are pleased to see that the FIGARO-DKD data provide further evidence for the FIDELIO-DKD study in terms of reducing the risk of a combination of cardiovascular death and non-fatal cardiovascular events or outcomes in patients with chronic kidney disease and chronic type provide 2 diabetes. “1.8

The Phase III program of finerenone in CRF and T2D randomized approximately 13,000 patients in a wide range of severity levels, including patients with early kidney damage and more advanced stages of kidney disease.2,3 FIGARO-DKD is a randomized, double-blind, placebo-controlled, Phase III event-driven parallel group study comparing finerenone versus placebo in patients with CKD and T2D.3,9 The study randomized approximately 7,400 patients from more than 1,000 locations in 47 countries worldwide. 3.9 patients were randomized to receive either finerenone 10 mg or 20 mg orally once daily or placebo when added to standard of care, including hypoglycemic therapies and maximum tolerated dose of the guideline-driven therapies angiotensin converting enzyme inhibitors (ACEIs) or angiotensin II receptor blockers (ARBs) .3,9

The new drug application (NDA), which is currently being reviewed by the US FDA for priority review, is based on positive data from the Phase III FIDELIO-DKD study. The results of this study were presented at the American Society of Nephrology’s (ASN) Kidney Week Reimagined 2020 and simultaneously published in the New England Journal of Medicine in October 2020.8 FIGARO-DKD’s clinical data will be presented at an upcoming scientific meeting.

About Finerenone

Finerenone (BAY 94-8862) is a nonsteroidal selective mineralocorticoid receptor antagonist (MRA) that has been shown to reduce many of the deleterious effects of overactivation of the mineralocorticoid receptor (MR ).10 Overactivation of the mineralocorticoid receptor is a driver of the kidney and cardiovascular damage from inflammatory and fibrotic processes.11,12 In 2015, the Food and Drug Administration gave Finerenone the designation Fast Track.

About chronic kidney disease in type 2 diabetes

Chronic kidney disease is a life-threatening condition that goes undetected. CRF is one of the most common complications of diabetes and an independent risk factor for cardiovascular disease.13 In this press release, the terms “diabetic kidney disease” and “chronic kidney disease in type 2 diabetes” are used interchangeably. Approximately 40 percent of all patients with T2D develop CKD.14 Despite guideline-driven therapies, patients with CKD and T2D remain at high risk for CKD progression and cardiovascular events.13,15 In 2013, diabetes resulted in more than 51,000 new kidney failure cases in the USA 16 Chronic kidney disease in T2D is the leading cause of kidney disease and end-stage kidney failure. In advanced stages, patients may need dialysis or a kidney transplant to stay alive.17,18 Overactivation of the mineralocorticoid receptor is known to be harmful to processes (e.g., inflammation and fibrosis) in the kidneys and heart in patients with CKD and T2D.11

About Bayer’s commitment to cardiovascular and kidney diseases

Bayer is a leader in innovation in the field of cardiovascular disease and has long been committed to delivering science for better lives through the advancement of a portfolio of innovative therapies. The heart and kidneys are closely related in terms of health and disease, and Bayer is working on new treatments for cardiovascular and kidney diseases with high unmet medical needs in a variety of therapeutic areas. Bayer’s cardiology franchise 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, prioritizing goals and pathways that may affect the way cardiovascular disease is treated.

About Bayer

Bayer is a global company with core competencies in the life science sectors of healthcare and nutrition. Its products and services are designed to help people and planets flourish by supporting efforts to meet the great challenges of a growing and aging world population. Bayer is committed to promoting sustainable development and making a positive impact on its business. At the same time, the group wants to increase its profitability and create value through innovation and growth. The Bayer brand stands for trust, reliability and quality around the world. In the 2020 financial year, the group employed around 100,000 people and achieved sales of 41.4 billion euros. R&D expenses before special items amounted to 4.9 billion euros. Further information is available at www.bayer.com.

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Forward-Looking Statements

This press 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 can lead to material differences between the actual future results, the financial situation, the 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 for updating these forward-looking statements or for adapting them to future events or developments.

References:

  1. Data in file.

  2. Bakris G et al. Design and baseline properties of finerenone in reducing kidney failure and disease progression in the diabetic kidney disease study. On J Nephrol 2019; 50 (5): 333- 344.

  3. Ruilope LM et al. Design and baseline properties of finerenone in reducing cardiovascular mortality and morbidity in a study of diabetic kidney disease. American Journal of Nephrology. 2019. 50 (5), 345- 356

  4. International Diabetes Federation. IDF Diabetes Atlas Ninth Edition. 2019.

  5. Zheng Y et al. Global etiology and epidemiology of type 2 diabetes mellitus and its complications. Nature Reviews Endocrinology. 2018. 14 (2), 88-98.

  6. Wu B et al. Understanding CKD in Patients with T2DM: Prevalence, Trends over Time, and Treatment Patterns – NHANES 2007–2012. British Medical Journal Open Diabetes Research and Care. 2016. 4 (1), e000154.

  7. Bailey, R. et al. Chronic Kidney Disease in Adults in the United States with Type 2 Diabetes: An Updated National Prevalence Estimate Based on Renal Failure: Improvement in Global Results (KDIGO). BMC Res Notes. 2014; 7: 415.

  8. Bakris G et al. Effect of finerenone on chronic kidney disease outcomes in type 2 diabetes. New England Journal of Medicine. 2020. 383, 2219-2229.

  9. ClinicalTrials.gov. Efficacy and safety of finerenone in patients with type 2 diabetes mellitus and a clinical diagnosis of diabetic kidney disease (FIGARO-DKD). 2015. Available at: https://clinicaltrials.gov/ct2/show/NCT02545049. Last accessed March 2021.

  10. Kolkhof P et al. Steroidal and novel non-steroidal mineralocorticoid receptor antagonists in heart failure and cardiorenal diseases: comparison at the bench and at the bedside. Heart failure. Manual of Experimental Pharmacology. 2017. 243, 271- 305

  11. Bauersachs J, et al. Mineralocorticoid receptor activation and mineralocorticoid receptor antagonist treatment in heart and kidney diseases. Hypertension. 2015 Feb; 65 (2): 257- 63.

  12. Buonafine, M, et al. Mineralocorticoid Receptor and Cardiovascular Diseases. Am J Hypertens. 2018; 31 (11): 1165-1174.

  13. Alicic RZ et al. Diabetic Kidney Disease: Challenges, Advances, and Opportunities. Clinical Journal of the American Society of Nephrology. 2017. 12 (12), 2032-2045.

  14. International Diabetes Foundation. IDF Diabetes Atlas 8th Edition 2017. Accessed October 5, 2020. https://www.diabetesatlas.org/en.

  15. Pálsson, R. et al. Cardiovascular complications in diabetic kidney disease. Adv Chronic Kidney Dis. 2014; 21 (3): 273-280.

  16. National Kidney Foundation. Diabetes and chronic kidney disease. Accessed October 6, 2020. https://www.kidney.org/news/newsroom/factsheets/Diabetes-And-CKD.

  17. Doshi SM et al. Diagnosis and Treatment of Type 2 Diabetic Kidney Disease. Clinical Journal of the American Society of Nephrology. 2017. 12 (8), 1366-1373.

  18. Kidney Fund.org. Kidney failure. Available at: https://www.kidneyfund.org/kidney-disease/kidney-failure/. Last accessed April 22, 2020.

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