Bayer (BAYN) Study Result summary

Study background and unmet need

• Heart failure affects 64 million people globally, with high mortality and limited treatment options for those with LVEF ≥40%.

• Finerenone, a non-steroidal mineralocorticoid receptor antagonist, targets MR overactivation and the cardiorenal axis, offering a favorable safety profile.

• Patients with mildly reduced or preserved ejection fraction have SGLT2 inhibitors as the only other guideline-recommended therapy.

Study design and population

• FINEARTS-HF was a randomized, double-blind, placebo-controlled phase III trial in 6,001 adults with HF and LVEF ≥40% across 37 countries.

• Patients received finerenone or placebo once daily, in addition to standard therapy for symptoms and comorbidities.

• The study population included a high percentage of hospitalized or recently hospitalized patients, reflecting real-world complexity.

• Baseline characteristics were well balanced and similar to other contemporary HFmr/pEF trials.

• Effects of finerenone were consistent across age, sex, region, LVEF, comorbidities, and background therapies.

Key results and efficacy

• Finerenone reduced the composite of cardiovascular death and total HF events by 16% (rate ratio 0.84, p=0.007), with early and sustained benefit.

• The benefit was mainly driven by a reduction in HF events, with consistent effects across all pre-specified subgroups, including those on SGLT2 inhibitors.

• Secondary endpoints showed an 18% reduction in total HF events, improved patient-reported health status, and a favorable trend in all-cause mortality.

• No significant difference was observed in all-cause mortality or composite kidney outcomes between groups.