Mississauga, ON, October 23, 2020 – Detailed results from the Phase III FIDELIO-DKD study demonstrated that the investigational drug finerenone slowed the progression of chronic kidney disease (CKD) in patients with CKD and type 2 diabetes (T2D) compared to placebo. Finerenone significantly reduced the risk of the composite primary endpoint of time to kidney failure, a sustained decrease of estimated glomerular filtration rate (eGFR) ≥ 40% from baseline over a period of at least four weeks, or renal death by 18% (relative risk reduction, HR 0.82 [95% CI, 0.73-0.93; p=0.0014]) over a median duration of follow-up of 2.6 years when added to maximum tolerated dose of standard of care therapy. At 36 months, the number needed to treat to prevent a primary composite endpoint event was 29 [95% CI 16-166]. FIDELIO-DKD is the first large contemporary positive outcomes study in patients with CKD and T2D with a primary composite endpoint exclusively consisting of kidney-specific outcomes. The findings from the FIDELIO-DKD study, which is part of the largest Phase III clinical trial program to date in CKD and T2D, were presented at the American Society of Nephrology’s (ASN) Kidney Week 2020, and simultaneously published in the New England Journal of Medicine.

“Despite available treatments focusing on hemodynamic and metabolic pathways, there is residual risk of kidney disease progression in patients with chronic kidney disease and type 2 diabetes.The findings from FIDELIO-DKD provide important evidence suggesting a potential new strategy for treating these patients,” said Professor George L. Bakris, MD, Department of Medicine, American Heart Association Comprehensive Hypertension Center, University of Chicago Medicine, USA and principal investigator of FIDELIO-DKD. “Overactivation of the mineralocorticoid receptor contributes to inflammation and fibrosis in the kidneys and heart, representing a promising target for a new therapy. New strategies are needed to prevent further end-organ damage and slow patient’s rate of decline in kidney function. The results with finerenone are highly relevant, showing improvement in outcomes for these patients who currently have limited options.”

The effects of finerenone on the primary outcome were generally consistent across pre-specified subgroups, and the treatment effect was sustained throughout the duration of the study. Finerenone also significantly reduced the risk of the key secondary endpoint, a composite of time to cardiovascular death, non-fatal myocardial infarction, non-fatal stroke or hospitalization for heart failure compared to placebo by 14% (relative risk reduction, HR 0.86 [95% CI, 0.75-0.99; p=0.0339]) over a median duration of follow-up of 2.6 years. Patients in both groups received standard of care, including blood glucose lowering therapies and a maximum tolerated dose of a renin-angiotensin system (RAS)-blocking therapy such as an angiotensin-converting enzyme (ACE) inhibitor or an angiotensin II receptor blocker (ARB).

“These vulnerable patients need to be protected by delaying the need for dialysis or a kidney transplant, and to reduce their risk of cardiovascular events,” said Dr. Joerg Moeller, Member of the Executive Committee of Bayer AG's Pharmaceutical Division and Head of Research and Development. “There is a high unmet medical need in cardiovascular and kidney diseases, which we aim to address with our research and development efforts. The FIDELIO-DKD results demonstrate that finerenone may become a new potential therapeutic option for patients with chronic kidney disease and type 2 diabetes, who experience progressive loss of kidney function. We are pleased to have reached this important development milestone for finerenone that addresses a key driver involved in the progression of chronic kidney disease in type 2 diabetes.”

Finerenone was well-tolerated, which is consistent with the safety profile seen in previous studies with finerenone. Overall treatment-emergent adverse events and serious adverse events were similar between groups. The majority of adverse events were mild or moderate. The frequency of serious adverse events was lower in patients treated with finerenone (31.9%) compared to placebo (34.3%). Overall, hyperkalemia-related adverse events occurred more often in patients receiving finerenone compared with placebo (18.3% and 9%, respectively). Hyperkalemia-related serious adverse events were low (1.6% and 0.4%, respectively), and there was no hyperkalemia-related death in either treatment group. Treatment was discontinued due to hyperkalemia in 2.3% of patients treated with finerenone compared to 0.9% in the placebo group.

Finerenone does not yet have marketing authorization in Canada. Bayer will provide the data to Health Canada at the time of submission for marketing authorization.

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.

The Phase III program with finerenone in CKD and T2D enrolled more than 13,000 patients across a broad range of disease severity including those with early kidney damage and more advanced stages of kidney disease. It is the largest Phase III clinical trial program to date in CKD and T2D and comprises two studies, evaluating the effect of finerenone versus placebo on top of standard of care on both renal and cardiovascular outcomes.

FIDELIO-DKD (FInerenone in reducing kiDnEy faiLure and dIsease prOgression in Diabetic Kidney Disease) is a randomized, double-blind, placebo-controlled, parallel-group, multicenter, event-driven Phase III study that 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 from more than 1,000 sites across 48 countries worldwide. Finerenone 10 mg or 20 mg orally once daily 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), significantly reduced the combined risk of time to kidney failure, a sustained decrease of estimated glomerular filtration rate (eGFR) ≥ 40% from baseline over a period of at least four weeks, or renal death by 18% (relative risk reduction; HR 0.82 [95% CI, 0.73-0.93; p=0.0014]) over a median duration of follow-up of 2.6 years. The results for the individual components of the primary endpoint are kidney failure: HR 0.87, 95% CI (0.72-1.05); sustained ≥ 40% decrease in eGFR from baseline: HR 0.81, 95% CI (0.72-0.92); renal death only occurred in 4 patients (2 in each group). Finerenone also significantly reduced the risk of the key secondary endpoint, a composite of time to cardiovascular death, non-fatal myocardial infarction, non-fatal stroke or hospitalization for heart failure compared to placebo by 14% (relative risk reduction, HR 0.86 [95% CI, 0.75-0.99; p=0.0339]) over a median duration of follow-up of 2.6 years. The results for the individual components of the key secondary endpoint are: Cardiovascular death: HR 0.86, 95% CI (0.68-1.08); non-fatal myocardial infarction: HR 0.80, 95% CI (0.58-1.09); non-fatal stroke: 1.03, 95% CI (0.76-1.38); hospitalization for heart failure: HR 0.86, CI 95% (0.68-1.08).

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 cardiovascular morbidity and mortality in approximately 7,400 patients with CKD and T2D across 47 countries including sites in Europe, Japan, China, the U.S., and Canada.

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 ≥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 deadly condition that is underrecognized. CKD is one of the most frequent complications arising from diabetes and is also an independent risk factor of cardiovascular disease. Approximately 40% of all patients with type 2 diabetes 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 type 2 diabetes is the main cause of end stage kidney disease which requires dialysis or a kidney transplant to stay alive. MR over-activation is known to trigger detrimental processes (e.g. inflammation and fibrosis) in the kidneys and heart in patients with CKD and type 2 diabetes (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 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.ca.

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