Bayer announced today the initiation of the FINEARTS-HF study, a multicenter, randomized, double-blind, placebo-controlled Phase III study to evaluate the efficacy and safety of finerenone on morbidity and mortality in patients suffering from symptomatic heart failure (New York Heart Association class II-IV) with 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).

“No therapy is currently approved for patients with heart failure and preserved ejection fraction. These patients have a substantial risk for cardiovascular events, which represents an enormous unmet need in cardiovascular disease,” said Scott D. Solomon, MD, The Edward D. Frohlich Distinguished Chair, Professor of Medicine at Harvard Medical School, Director of Non-invasive Cardiology and Senior Physician at Brigham and Women’s Hospital and Chair of the study’s Executive Committee. “The FINEARTS-HF study will assess whether finerenone leads to a reduction in the risk of cardiovascular death and other heart failure events in these underserved patients.”

“Blockade of the mineralocorticoid receptor system has been shown to be of benefit in the treatment of heart failure. With the novel compound finerenone, Bayer is pursuing a new research approach in another heart failure patient population where a targeted therapy to reduce mortality and morbidity is still lacking,” said Dr. Joerg Moeller, Member of the Executive Committee of Bayer AG's Pharmaceutical Division and Head of Research and Development. “We are excited about finerenone being the first non-steroidal mineralocorticoid receptor antagonist that is being developed in heart failure with preserved ejection fraction.”

The planned Phase III FINEARTS-HF study will investigate finerenone compared to placebo in more than 5,500 symptomatic heart failure patients with a left ventricular ejection fraction of ≥40%. Patients will be randomized to receive either finerenone once daily (titrated up to 40 mg) or placebo. The study will be conducted in more than 34 countries including sites in Europe, Japan, China and the U.S.