Bayer to Present Results From Phase III FIDELIO-DKD Study with Finerenone in Patients with Chronic Kidney Disease and Type 2 Diabetes during Late-Breaker Session at the American Society of Nephrology’s Kidney Week 2020

Bayer will present detailed results from the Phase III FIDELIO-DKD study assessing the use of the investigational drug finerenone on kidney and cardiovascular outcomes in patients with chronic kidney disease (CKD) and type 2 diabetes (T2D) during scientific sessions of the upcoming American Society of Nephrology’s (ASN) Kidney Week, October 22-25, 2020. Additional data evaluating use of finerenone will also be presented.

The FIDELIO-DKD study, which evaluated the efficacy and safety of finerenone versus placebo when added to standard of care in patients with CKD and T2D, 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. Bayer announced earlier this year that FIDELIO-DKD met its composite primary renal endpoint and its composite key secondary cardiovascular endpoint.

Full data from the FIDELIO-DKD study will be presented as part of the live-streamed, late-breaker oral abstract session High-Impact Clinical Trials:

• “Effect of Finerenone on Chronic Kidney Disease Outcomes in Type 2 Diabetes” - October 23, 2020, 10:30 –10:45 am (EDT) (Abstract FR-OR51)

Additional scientific presentations include:

• “The novel nonsteroidal and selective MR antagonist finerenone differentiates from sodium glucose co-transporter 2 (SGLT2) inhibitor empagliflozin by anti-fibrotic effects in a progressive mouse kidney fibrosis model”
  • Session: CKD Mechanisms – 2
  • Poster: PO0646

• “Combined efficacy of the novel nonsteroidal and selective MR antagonist finerenone and the SGLT2 inhibitor empagliflozin in a non-diabetic cardiorenal rat model”
  • Session: CKD Mechanisms – 2
  • Poster: PO0642

• “Chronic kidney disease by previous diabetes or hypertension: a longitudinal outcomes study in primary care”
  • Session: CKD Epidemiology, Biomarkers, Predictors
  • Poster: PO0439

About the Finerenone Phase III Clinical Program

Finerenone (BAY 94-8862) is an investigational, non-steroidal, selective mineralocorticoid receptor antagonist.¹ The Phase III clinical program with finerenone in CKD and T2D is the largest Phase III clinical trial program to date in CKD and T2D having 13,000 randomized patients across a broad range of disease severity including those with early kidney damage and more advanced stages of kidney disease. The clinical program comprises two studies (FIDELIO-DKD and FIGARO-DKD), evaluating the effect of finerenone versus placebo in addition to the standard of care in 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.

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 and the U.S.

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 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.us.

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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.

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¹ 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.        

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