Bayer Initiates a Phase III Study in Heart Failure Patients

Bayer Aktiengesellschaft BAYRY announced the initiation of FINEARTS-HF, a placebo-controlled phase III study on finerenone. The study will investigate finerenone compared to placebo in more than 5,500 symptomatic heart failure patients with a left ventricular ejection fraction of ≥40%.

The primary objective of the study is to demonstrate the 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. Patients will be randomized to receive either finerenone once daily (titrated up to 40 mg) or placebo. The FINEARTS-HF study will assess whether the candidateleads to a reduction in the risk of cardiovascular death and other heart failure events in patients.

Finerenone (BAY 94-8862) is an investigational, non-steroidal, selective mineralocorticoid receptor antagonist that has been shown to block the harmful effects of the over-activated mineralocorticoid receptor (MR) system. MR overactivation is a major driver of heart and kidney damage. It is the first non-steroidal MR antagonist that is being developed in heart failure with preserved ejection fraction.

Shares of the company have lost 6.8% year to date compared with the industry’s decline of 5.3%.

The initiation of the FINEARTS-HF study is based onthe 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 (CKD), respectively.

Finerenone is already being investigated in large, long-term outcome studies in patients with CKDand type II diabetes (T2D).

We remind investors that, earlier this month, the company submitted regulatory applications seeking the approval of pipeline candidate, vericiguat, in the EU and Japan. Vericiguat is an experimental once-daily, first-in-class soluble guanylate cyclase (sGC)-stimulator being developed to treat patients with symptomatic chronic heart failure with an ejection fraction less than 45%, who have had a previous worsening heart failure event (defined as heart failure hospitalization or receiving an intravenous diuretic for heart failure without hospitalization), in combination with available heart failure therapies.

Bayer is developing the candidate in collaboration with Merck MRK.

Novartis’ NVS Entresto is approved to reduce the risk of death and hospitalization in people with certain types of long-lasting (chronic) heart failure.

Bayer is undertaking several initiatives to strengthen its position across portfolios, enhance efficiency and accelerate structural measures, including the decision to exit the Animal Health business unit. The company had earlier announced the divestment of its Animal Health business to Elanco ELAN. Meanwhile, the Monsanto acquisition in 2018 has strengthened Bayer's position.

 

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Bayer currently carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

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