Bayer Unveils New Biomarker Study Supporting Kerendia®'s Mechanism in CKD Patients with T2D

03 November 2023 | Friday | News

New Human Biomarker Findings Support Mechanism of Action of Kerendia® (finerenone) in Patients with Chronic Kidney Disease Associated with Type 2 Diabetes
Image Source | Public Domain

Image Source | Public Domain

At the American Society of Nephrology’s (ASN) Kidney Week 2023, Bayer today announced pharmacodynamic data on Kerendia® (finerenone), the first non-steroidal, selective mineralocorticoid receptor (MR) antagonist to demonstrate dual cardiorenal risk reduction in adult patients with chronic kidney disease (CKD) and type 2 diabetes (T2D). 2

Kerendia is indicated to reduce the risk of sustained eGFR decline, end-stage kidney disease, cardiovascular death, non-fatal myocardial infarction, and hospitalization for heart failure in adult patients with CKD associated with T2D.3 The Kerendia label contains a Warning and Precaution that Kerendia can cause hyperkalemia. For more information, see “Important Safety Information” below.

The data from FIGARO-BM, an exploratory human biomarker study, provide findings which support the mechanism of action of Kerendia in blocking MR overactivation, thought to contribute to inflammation and fibrosis. Left untreated, inflammation and fibrosis can lead to damage in the kidneys and heart. 3

“The biomarker findings from FIGARO-BM are an important moment for Bayer,” said Dr. Christian Rommel, Member of the Executive Committee of Bayer AG's Pharmaceutical Division and Head of Research and Development. “In addition to existing preclinical data, we now have data from human biomarkers that support finerenone's mechanism of action in blocking MR overactivation which can lead to inflammation and fibrosis.”

The FIGARO-BM study aims to elucidate the mode-of-action (MOA) of finerenone. More than 2,900 plasma biomarkers derived from biosamples from 945 patients who were treated with either placebo or finerenone for at least 36 months in the Phase III study FIGARO-DKD were analyzed.1 Future studies are needed to validate these findings.

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