Bayer (BAYN) Study Result summary

Study background and unmet need

• Heart failure affects 64 million people globally, with high mortality, hospitalization rates, and significant healthcare costs, especially in patients with LVEF ≥40%.

• Patients with mildly reduced or preserved ejection fraction have limited treatment options, mainly SGLT2 inhibitors.

• Finerenone, a non-steroidal MRA, targets MR overactivation to reduce inflammation and fibrosis, offering a favorable safety profile.

• FINEARTS-HF and FINE-HEART are large-scale studies evaluating finerenone's efficacy and safety in HF and across the cardiovascular-kidney-metabolic spectrum.

FINEARTS-HF study design and population

• Randomized, double-blind, placebo-controlled phase III trial with 6,001 patients with HF and LVEF ≥40% in 37 countries.

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

• The primary endpoint was a composite of cardiovascular death and total (first and recurrent) HF events.

• 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.

Key results and efficacy

• Finerenone reduced the primary composite outcome by 16% (rate ratio 0.84, 95% CI 0.74-0.95, p=0.0072), mainly driven by fewer HF events.

• Benefits appeared early and were consistent across all 17 pre-specified subgroups, including those on SGLT2 inhibitors.

• Significant 18% reduction in total worsening HF events and improved patient-reported health status (KCCQ score).

• No significant difference in all-cause mortality or composite kidney outcomes; all-cause mortality numerically improved but not statistically significant.

• Safety profile was consistent with previous studies; hyperkalemia increased but was mostly mild and rarely led to hospitalization or death.