Mississauga, May 21, 2021 – Bayer’s Phase III study FIGARO-DKD, evaluating the efficacy and safety of the investigational drug finerenone versus placebo when added to standard of care in patients with chronic kidney disease (CKD) and type 2 diabetes (T2D), has met its primary endpoint, showing that finerenone significantly reduced the composite risk of time to first occurrence of cardiovascular (CV) death or non-fatal CV events (myocardial infarction, stroke or hospitalization for heart failure). Compared to FIDELIO-DKD, the first of the two Phase III studies investigating finerenone in patients with CKD and T2D, FIGARO-DKD included more patients with earlier stage CKD and T2D. 

“An estimated 160 million patients globally are living with chronic kidney disease and type 2 diabetes, and they are at high risk of experiencing cardiovascular events, as well as progressing to kidney failure,” said Prof. Luis M. Ruilope, Professor at the Cardiorenal Translational Laboratory and Hypertension Unit, Institute of Research imas12, Madrid, Spain, and co-principal investigator of the FIGARO-DKD trial. “The FIGARO-DKD study delivers important insights into the cardiovascular benefits of finerenone, suggesting its potential to offer physicians a new tool in their armamentarium to protect these vulnerable patients by reducing their risk of cardiovascular events.” 

“Overactivation of the mineralocorticoid receptor contributes to inflammation and fibrosis in the kidneys and heart. With the positive outcome of the composite primary endpoint of the FIGARO-DKD trial, we have reached a significant milestone by completing the largest Phase III clinical trial program to date focusing on chronic kidney disease and T2D across a broad range of disease severity,” said Dr. Christian Rommel, Member of the Executive Committee of Bayer AG's Pharmaceutical Division and Head of Research and Development. "We are pleased to see that the FIGARO-DKD data further support the evidence generated in the FIDELIO-DKD trial with respect to reducing the combined risk of cardiovascular death or non-fatal cardiovascular outcomes in patients with chronic kidney disease and type 2 diabetes.”

The FIGARO-DKD study is part of the largest Phase III clinical trial program to date in CKD and T2D, 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. FIGARO-DKD is a randomized, double-blind, placebo-controlled, parallel-group, event-driven Phase III study investigating finerenone versus placebo in patients with CKD and T2D. The study included approximately 7,400 patients from more than 1,000 sites across 47 countries worldwide, including Canada. 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 RAS-blocking therapy such as angiotensin-converting enzyme (ACE) inhibitors or angiotensin II receptor blockers (ARBs).

The marketing authorization application (MAA) submitted to the EMA, and the new drug application (NDA) accepted by U.S. FDA for Priority Review were based on positive data from the previously completed Phase III FIDELIO-DKD study and are currently under review. Results from this trial 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. The clinical data from FIGARO-DKD will be presented at an upcoming scientific meeting. Finerenone does not yet have marketing authorization in Canada.

About Finerenone
Finerenone (BAY 94-8862) is an investigational novel, non-steroidal, selective mineralocorticoid receptor antagonist (MRA) that has been shown to block many of the harmful effects of mineralocorticoid receptor (MR) overactivation. MR overactivation is a major driver of kidney and cardiovascular damage through inflammatory and fibrotic processes. 

Having randomized more than 13,000 patients with CKD and T2D around the world, the Phase III program with finerenone in CKD and T2D comprises two studies evaluating the effect of finerenone versus placebo on top of standard of care on both renal and cardiovascular outcomes. FIGARO-DKD (FInerenone in reducinG cArdiovascular moRtality and mOrbidity in Diabetic Kidney Disease) investigated the efficacy and safety of finerenone versus placebo in addition to standard of care on the reduction of cardiovascular morbidity and mortality in approximately 7,400 patients with CKD and T2D across 47 countries including sites in Canada, Europe, Japan, China and the U.S. The study met its primary endpoint. 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. 

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 patients with symptomatic heart failure (New York Heart Association class II-IV) with a left ventricular ejection fraction of ≥40%. The primary objective of the study is to demonstrate superiority of finerenone over placebo in reducing the rate of the composite endpoint of cardiovascular 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 (CKD) is a potentially deadly condition that is generally underrecognized. 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 chronic kidney disease. 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 160 million people with T2D worldwide. Chronic kidney disease in T2D is the main cause of end stage kidney disease, which requires dialysis or a kidney transplant to stay alive. MR overactivation is known to trigger detrimental processes (e.g. inflammation and fibrosis) in kidneys and heart in patients with CKD and (T2D).

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. Its products and services are designed to help people and planet thrive by supporting efforts to master the major challenges presented by a growing and aging global population. Bayer is committed to drive sustainable development and generate 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 2020, the Group employed around 100,000 people and had sales of 41.4 billion euros. R&D expenses before special items amounted to 4.9 billion euros. For more information, go to www.bayer.ca.

Contact:
Corporate Communications
mediacanada@bayer.com

xx    (2021-0XXXE)

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.