Date: 19-Jun-2020

Bayer Initiates Phase III FINEARTS-HF Study For Finerenone In Patients With Heart Failure And Preserved Ejection Fraction

Bayer announced 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 US.

Finerenone (BAY 94-8862) is an investigational novel, non-steroidal, selective mineralocorticoid receptor antagonist (MRA) that has been shown to block the harmful effects of the overactivated mineralocorticoid receptor (MR) system. MR overactivation is a major driver of heart and kidney damage. Current steroidal MRAs on the market have proven to be effective in reducing cardiovascular mortality in patients suffering from heart failure with reduced ejection fraction (HFrEF). However, they are often underutilized due to the incidence of hyperkalemia, renal dysfunction, and anti-androgenic / progestogenic side effects.

The initiation of the phase III FINEARTS-HF study (FINerenone trial to investigate Efficacy and sAfetysuperioR to placebo in paTientS with Heart Failure) builds upon the robust phase II studies ARTS-HF and ARTS-DN which investigated the efficacy and safety of finerenone in patients with heart failure and chronic kidney disease, respectively.

Within the last 8 years, the approximate global prevalence of Heart Failure has doubled to over 60 million people. Heart failure is characterized by the progressive decline in the heart’s ability to pump enough blood to meet the body’s needs for blood and oxygen. Symptoms may include shortness of breath, fatigue, chest discomfort and swelling in the lower body. Risk factors are hypertension, diabetes mellitus, smoking, a past myocardial infarction, and coronary artery disease.

When categorized by ejection fraction, HF is divided into two main forms, each accounting for approximately 50% of HF patients: heart failure with reduced ejection fraction (HFrEF) is characterized by the compromised ability of the heart to eject oxygen rich blood sufficiently during its contraction phase.

The other form of HF is heart failure with preserved ejection fraction (HFpEF), a condition characterized by stiffness of the heart leading to filling abnormalities and increased pressure in the heart. The prevalence increases with age and hospitalizations for HFpEF have increased over time. Morbidity and mortality in HFpEF are similar to values observed in patients with HFrEF. While advances in therapy have been achieved in HFrEF, there is so far no treatment currently approved for HFpEF. Recommendations have been limited to symptomatic treatment of congestive symptoms by diuretics, and to treating causes and comorbidities