Mississauga, ON, March 10, 2021 – Bayer has recently announced the initiation of the CONFIDENCE study, a Phase II, three-arm study that will investigate simultaneous initial combination therapy with finerenone and the SGLT2 inhibitor empagliflozin, compared with finerenone alone and empagliflozin alone, respectively in patients with chronic kidney disease (CKD) and type 2 diabetes (T2D).4 The primary objective of the study is to demonstrate that the simultaneous initiation and combined use of finerenone and empagliflozin is superior to either empagliflozin alone, or finerenone alone, in reducing urine albumin-to-creatinine ratio (UACR).4  The primary outcome is the relative change from baseline in UACR at 180 days in the combination therapy group vs the monotherapy groups.⁴

“UACR is an important predictor of long-term renal and cardiovascular outcomes in chronic kidney disease and type 2 diabetes patients, with elevated levels indicating worsening kidney damage.5 In a post-hoc analysis of the FIDELIO-DKD study, finerenone indicated a reduction in UACR levels with or without an SGLT2 inhibitor at baseline. An efficient intervention assessed by UACR reduction may provide long-term benefits for patients,6 ” said Rajiv Agarwal, MD, Professor of Medicine, Indiana University School of Medicine and VA Medical Centre, Indianapolis, USA and Chair of the study’s Steering Committee. “If successful, the results of the CONFIDENCE study could be of great significance to clinicians when considering how to optimize disease management and further delay kidney disease progression, while also providing additional insights into the safety of using these treatments in combination.”

Finerenone, a non-steroidal, selective mineralocorticoid receptor (MR) antagonist, has been investigated in a broad population of patients with stages 1-4 CKD and T2D across two completed and published Phase III studies FIDELIO-DKD7 and FIGARO-DKD11 . The two studies evaluated the effects of finerenone versus placebo on top of standard of care on both renal and cardiovascular outcomes in patients with CKD and T2D.The initiation of the Phase II CONFIDENCE study (COmbinatioN effect of FInerenone anD EmpaglifloziN in participants with CKD and T2D using an UACR Endpoint study) builds on the robust Phase III results with finerenone. 

“Despite treatment with standard of care, the residual risk for cardiorenal events remains high in patients living with chronic kidney disease and type 2 diabetes.1 ^,2  There is a high unmet need for treatments that can reduce the extensive burden associated with the progression of kidney disease and the connected risk of cardiovascular events,1 2 3 ” said Dr. Michael Devoy, Chief Medical Officer and Head of Medical Affairs and Pharmacovigilance at Bayer’s Pharmaceuticals Division. “We expect the CONFIDENCE study to extend our clinical insights on finerenone and hope to be able to provide evidence on the potential additive cardiovascular and renal benefits of combination therapy with finerenone and an SGLT2 inhibitor.3 ” 

The Phase II CONFIDENCE study will investigate finerenone plus empagliflozin compared with either finerenone or empagliflozin alone in about 870 patients with CKD and T2D4. Patients will be randomized in a 1:1:1 ratio stratified by estimated glomerular filtration rate (eGFR) and UACR at screening and will receive either finerenone (10 or 20 mg once daily) and empagliflozin (10 mg), finerenone (10 or 20 mg) and matching placebo to empagliflozin, or empagliflozin (10 mg) and matching placebo to finerenone.4  

Based on the positive results of the FIDELIO-DKD Phase III study, finerenone was granted marketing authorization in the European Union and was approved by the U.S. Food and Drug Administration (FDA) under the brand name Kerendia®. Finerenone has also been submitted for marketing authorization in multiple other countries worldwide, including Canada, and these applications are currently under review. Finerenone does not yet have marketing authorization in Canada. 

About Finerenone
Finerenone (BAY 94-8862) is a non-steroidal, selective mineralocorticoid receptor (MR) antagonist that in preclinical studies has been shown to block harmful effects of MR overactivation. In T2D, MR overactivation is thought to contribute to CKD progression and cardiovascular damage which can be driven by metabolic, hemodynamic or inflammatory and fibrotic factors.7 1 8 9 10 The Phase III study programme with finerenone, FINEOVATE, currently comprises four Phase III studies, FIDELIO-DKD7, FIGARO-DKD, FINEARTS-HF and FIND-CKD.

Having randomized more than 13,000 patients with CKD and T2D around the world, including Canada, 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.14 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.7 15 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.16  

In September 2021, Bayer announced the initiation of the FIND-CKD study, a multicenter, randomized, double-blind, placebo-controlled Phase III study which will investigate finerenone in patients with non-diabetic chronic kidney disease. FIND-CKD will investigate the efficacy and safety of finerenone in addition to guideline-directed therapy on the progression of chronic kidney disease (CKD) in more than 1,500 patients with non-diabetic chronic kidney disease etiologies, including hypertension and chronic glomerulonephritis (inflammation of the kidneys). The primary outcome measure is the mean rate of change in kidney function over time (estimated glomerular filtration rate, eGFR slope) from baseline to month 32.

In June 2020, Bayer 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 preserved ejection fraction, i.e. 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).

Finerenone was granted marketing authorization in the European Union and was approved by the U.S. Food and Drug Administration (FDA) under the brand name Kerendia®. Finerenone has also been submitted for marketing authorization in multiple other countries worldwide, including Canada and these applications are currently under review. Finerenone does not yet have marketing authorization in Canada. 

About Chronic Kidney Disease in Type 2 Diabetes
Chronic kidney disease (CKD) is a potentially deadly condition that is generally underrecognized.17 CKD is one of the most frequent complications arising from diabetes and is also an independent risk factor of cardiovascular disease.18 Up to 40% of all patients with type 2 diabetes develop chronic kidney disease.1 17 19  Despite guideline-directed therapies, patients with CKD and T2D remain at high risk of CKD progression and cardiovascular events.1 5 17  It is estimated that CKD affects more than 160 million people with T2D worldwide.20 21 22  Chronic kidney disease in type 2 diabetes is the main cause of end stage kidney disease,17 which requires dialysis or a kidney transplant to stay alive. Patients with chronic kidney disease and type 2 diabetes are three times more likely to die from a cardiovascular-related cause than those with type 2 diabetes alone.24

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 2021, the Group employed around 100,000 people and had sales of 44.1 billion euros. R&D expenses before special items amounted to 5.3 billion euros. For more information, go to www.bayer.ca.

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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. 
 

• 4 a b c d [CONFIDENCE PLACEHOLDER]
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