Bayer extends clinical development program for finerenone with Phase II study investigating the initial combination therapy with empagliflozin in patients with chronic kidney disease and type 2 diabetes

There is a high unmet need for new treatments to preserve kidney function and delay kidney disease progression in patients with chronic kidney disease (CKD) and type 2 diabetes (T2D) / The Phase II CONFIDENCE study will investigate the effect of the simultaneous initiation of combination therapy with finerenone and the SGLT2 inhibitor empagliflozin in patients with CKD and T2D

Bayer announced today 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). 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). The primary outcome is the relative change from baseline in UACR at 180 days in the combination therapy group vs the monotherapy groups.

“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. 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,” 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 type 2 diabetes (T2D) across two completed and published Phase III studies: FIDELIO-DKD and FIGARO-DKD 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. 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,” 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.”

The Phase II CONFIDENCE study will investigate finerenone plus empagliflozin compared with either finerenone or empagliflozin alone in about 870 patients with CKD and T2D. 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.

About Chronic Kidney Disease in Type 2 Diabetes
Chronic kidney disease (CKD) is a common and potentially deadly condition that is widely underrecognized. CKD progresses silently and unpredictably, with many symptoms not appearing until the disease is well-advanced. 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 type 2 diabetes (T2D) develop CKD. 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. CKD in T2D is the main cause of end stage kidney disease, which requires dialysis or a kidney transplant to stay alive. Patients with CKD and T2D are three times more likely to die from a cardiovascular-related cause than those with T2D alone.

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.

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.

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