Today, Bayer announced that its investigational therapyFinerenone Met Primary Endpoint in the Phase 3 FIDELIO-DKD Trial in Patients with Chronic Kidney Disease (CKD) and Type 2 DiabetesCompared with placebo, the addition of finerenone to standard care delayed the time to first occurrence of kidney failure, reduced the risk of death due to kidney disease, and slowed the decline in estimated glomerular filtration rate (eGFR).

Meanwhile, finerenone also reduced the risk of key secondary endpoints, which were a composite endpoint consisting of time to first occurrence of cardiovascular (CV) death, non-fatal myocardial infarction, non-fatal stroke, or hospitalization for heart failure. Clinical data from FIDELIO-DKD will be presented at upcoming scientific conferences.Chronic kidney disease is one of the most common complications of diabetes and an independent risk factor for cardiovascular disease. Approximately 40% of patients with type 2 diabetes develop chronic kidney disease. Chronic kidney disease in patients with type 2 diabetes is a leading cause of end-stage renal disease and kidney failure, with advanced-stage patients potentially requiring dialysis or kidney transplantation for survival. It is well established that excessive activation of mineralocorticoid receptors can trigger harmful processes in the kidneys and heart, such as inflammation and fibrosis.Finerenone (BAY94-8862) is an investigational nonsteroidal selective mineralocorticoid receptor antagonist (MRA) that reduces the harmful effects of excessive mineralocorticoid receptor (MR) activation.Overactivation of the Mineralocorticoid Receptor Is the Primary Driver of Renal and Cardiac Damage. In 2015, the U.S. FDA granted Fast Track designation to Finerenone。

▲Molecular structure of finerenone (Image source: The Titou / Public domain)

The FIDELIO-DKD trial enrolled 13,000 patients with a wide spectrum of disease severity, ranging from those with early kidney damage to those with advanced kidney disease. FIDELIO-DKD was a randomized, double-blind, placebo-controlled, parallel-group, multicenter, event-driven Phase 3 clinical study comparing the efficacy of finerenone versus placebo in patients with chronic kidney disease (CKD) and type 2 diabetes.Bayer recently announced the initiation of the FINEARTS-HF study, a multicenter, randomized, double-blind, placebo-controlled Phase 3 clinical trial designed to evaluate the efficacy of finerenone in reducing the risk of cardiovascular death and heart failure events in more than 5,500 patients with heart failure and a left ventricular ejection fraction (LVEF) of ≥40%.

References:

[1] Bayer’s Finerenone Meets Primary Endpoint in Phase III FIDELIO-DKD Renal Outcomes Study in Patients With Chronic Kidney Disease and Type 2 Diabetes. Retrieved July 9, 2020, from https://www.businesswire.com/news/home/20200709005224/en

Flash Update | Bayer’s Innovative Therapy Meets Phase 3 Clinical Endpoints, Reducing Risks of Kidney Disease and Cardiovascular Events

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