Presentation at EASD meeting of new cardiorenal data for Kerendia across a broad range of patients with early to late-stage chronic kidney disease and type 2 diabetes

This data will include new post-hoc analyses of FIDELITY, a prespecified pooled analysis of FIDELIO-DKD and FIGARO-DKD, as well as the design of the Phase II CONFIDENCE study, investigating simultaneous initial combination therapy with finerenone and an SGLT2-inhibitor in patients with chronic kidney disease (CKD) and type 2 diabetes (T2D).

Kerendia FIDELITY study data: i. The prespecified pooled analysis FIDELITY, including the FIDELIO-DKD and FIGARO-DKD studies, comprises data in more than 13,000 patients with CKD and T2D. FIDELITY investigated the efficacy and safety of Kerendia across a broad range of patients with early to late-stage CKD and T2D and provided insights into the relationship between CKD stage (based on baseline Kidney Disease: Improving Global Outcomes – KDIGO – risk categories) and the effects of Kerendia on composite CV and kidney-specific endpoints.ii. Data from a new post-hoc analysis from FIDELITY evaluated the effects of Kerendia on kidney and CV outcomes by use of glucagon-like peptide-1 receptor agonists (GLP-1RA) at baseline. This analysis encompasses a population including patients with earlier stages of CKD than was included in the FIDELIO-DKD trial.

iii. An additional post-hoc analysis from FIDELITY will investigate the effect of Kerendia by baseline HbA1c categories, HbA1c variability, and diabetes duration in patients with CKD and T2D. Despite well-controlled blood glucose levels and blood pressure, many patients with CKD and diabetes still progress to loss of kidney function. New therapeutic strategies are needed to prevent further end-organ damage and slow patient’s rate of decline in kidney function. Iv.Further data from FIDELITY will investigate the efficacy and safety of Kerendia in CKD and T2D patients with obesity, as defined by a substantially increased waist-hip ratio. Kerendia is the first non-steroidal, selective mineralocorticoid receptor (MR) antagonist to demonstrate positive kidney and CV outcomes in patients with CKD and T2D. Patients with visceral adiposity have been shown previously to respond better to MR antagonists than patients without visceral adiposity.

Bayer will also present the design of the Phase II CONFIDENCE study, investigating simultaneous initial combination therapy with finerenone and an SGLT2-inhibitor in patients with CKD and T2D. Despite guideline-directed therapies, patients with CKD and T2D remain at high risk of CKD progression and CV events. It is currently unknown whether dual therapy with finerenone and a SGLT2i is superior to either agent alone. The CONFIDENCE study aims to address this clinical question.