Bayer's finerenone clears key heart failure trial

At the start of this year, Bayer said there were two important trial readouts for the company to deliver near-term growth this year as it rebuilds its pipeline – and both have now delivered positive results in the space of a month.

This morning, the German group revealed that mineralocorticoid receptor antagonist (MRA) Kerendia (finerenone) was able to reduce cardiovascular death and other heart failure events compared to placebo in the FINEARTS-HF trial.

The study enrolled patients with heart failure with a mildly reduced or preserved left ventricular ejection fraction (LVEF) of 40% or greater – a group with few available therapies – and is comparing finerenone to placebo on top of standard therapies.

According to Bayer, it demonstrated a "clinically meaningful" reduction in the composite endpoint of cardiovascular death and hospitalisations or urgent clinic visits for heart failure, the first time that an MRA has done so in this patient population. Patients with LVEF of 40% or more tend to be sicker and account for around half of all heart failure patients.

The positive results will form the basis of regulatory filings to extend the indications of finerenone beyond its current use in chronic kidney disease (CKD) associated with type 2 diabetes. It made €270 million last year – up 152% – but the heart failure indication will be needed if it is to reach a peak sales projection of €3 billion.

It comes after Bayer's Nubeqa (darolutamide) hit the mark in the ARANOTE trial in metastatic, hormone-sensitive prostate cancer (mHSPC) in mid-July, a key part of Bayer's plan to build the drug into another €3 billion-a-year blockbuster.

"We are very excited by the positive results from the FINEARTS-HF study," said Dr Christian Rommel, head of R&D at Bayer's pharma division. "With limited options currently available for patients with this common form of heart failure…this news is hugely important for patients and the clinical community," he added.

FINEARTS-HF is one of four phase 3 studies that Bayer is hoping to make finerenone a go-to therapy for heart failure patients, alongside the REDEFINE-HF trial of the drug as monotherapy in patients with an LVEF of 40% or more, and the FINALITY-HF study as a monotherapy in those with an LVEF below 40%.

Finally, the company is also running an open-label study – CONFIRMATION-HF – testing finerenone with Boehringer/Eli Lilly's SGLT2 inhibitor Jardiance (empagliflozin) versus standard of care in patients hospitalised or recently discharged with heart failure, regardless of their LVEF status.