Bayer Announces Three Finerenone Studies at ESC and EASD 2024, Demonstrating Potential for Simultaneous Treatment of Two Comorbidities

China Finance Network September 12 -- Bayer recently announced the results of three finerenone studies at the 2024 European Society of Cardiology (ESC) annual meeting and the 2024 annual meeting of the European Association for the Study of Diabetes (EASD).

Among the results presented at ESC2024, the FINE-HEART study of Bayer's finerenone showed that, compared with the placebo group, the primary endpoint of cardiovascular death in the finerenone group was numerically reduced but narrowly missed statistical significance (11% relative risk reduction, HR 0.89 [95% CI 0.78–1.01; p=0.076]). However, in a pre-specified sensitivity analysis of the primary endpoint of FINE-HEART (including cardiovascular death and deaths of undetermined cause), finerenone significantly reduced the risk of events by 12% (relative risk reduction, HR 0.88 [95% CI, 0.79–0.98; p=0.025]). Across the 16 subgroups of the FINE-HEART study, the effect of finerenone on cardiovascular death remained consistent. Additionally, the results also demonstrated that, compared to placebo, finerenone significantly reduced all-cause mortality as well as cardiovascular and renal events. In summary, these findings indicate that finerenone provides cardiovascular and renal benefits in high-risk patients with coexisting cardiovascular, renal, and metabolic diseases.

The detailed results of the FINEARTS-HF Phase III study on Bayer's finerenone showed that, compared with placebo, finerenone significantly improved cardiovascular outcomes in heart failure patients with left ventricular ejection fraction (LVEF) ≥40%. Over a median treatment period of 32 months, finerenone significantly reduced the risk of the primary composite endpoint of cardiovascular death and total (first and recurrent) heart failure events (defined as hospitalization for heart failure or emergency visits for heart failure) by 16% (relative risk reduction, RR 0.84 [95% CI, 0.74-0.95; p=0.0072]). Based on this, finerenone is the first non-steroidal selective mineralocorticoid receptor antagonist to demonstrate definitive cardiovascular efficacy in a Phase III study for common heart failure.

Additionally, on September 10, 2024, the latest data released by Bayer at the 2024 Annual Meeting of the European Association for the Study of Diabetes (EASD) showed that, compared with placebo, finerenone treatment reduced the risk of new-onset diabetes by 24% in heart failure patients with left ventricular ejection fraction ≥40%. This data comes from a pre-specified analysis of the Phase III FINEARTS-HF study, which included approximately 6,000 heart failure patients. The results also indicated that, compared with placebo, finerenone reduced the composite risk of cardiovascular death and total heart failure events.

In response, at the Bayer Global Media Briefing, Dr. Harriette Van Spall, Senior Scientist at the Population Health Research Institute of McMaster University in Hamilton, Canada, Cardiologist and Director of Digital Health & Data, as well as Director of Implementation Science at the Baim Clinical Research Institute in Boston, USA, stated that although there are currently many therapies for treating heart failure, there aren't many proven effective treatment options specifically for patients with multiple comorbidities.

"Now we have a drug that can treat two important comorbidities at the same time, not only addressing heart failure symptoms and heart failure events but also tackling common comorbidities such as diabetes, kidney disease, and hypertension." Harriette Van Spal considers this a "one-stop" solution that treats not only heart failure but also kidney disease.

Is Finerenone Beneficial for All Heart Failure Patients with LVEF≥40%, Regardless of Their Comorbidities or Disease Progression? Scott D. Solomon, Professor at Harvard Medical School, Director of Non-Invasive Cardiology at Brigham and Women's Hospital, and Chair of the Executive Committee of the study, stated, "In our pre-specified 17 subgroups, no heterogeneity was found. We will conduct further analyses, but based on formal statistical tests, no heterogeneity has been observed. Regardless of whether patients have diabetes or kidney disease, finerenone has shown overall benefits."

Data show that heart failure (HF) is a complex clinical syndrome characterized by a gradual decline in the heart's pumping ability, unable to meet the body's demand for blood and oxygen. Heart failure affects more than 60 million people worldwide and is the leading cause of hospitalization for individuals over 65 years old. It is projected that within the next decade, the incidence of heart failure will rise sharply, partly due to an aging population. Heart failure can be complicated by various comorbidities, with over half of the patients also suffering from obesity, chronic kidney disease, diabetes, hypertension, or atrial fibrillation.

Kerendia (Finerenone Tablets) is a non-steroidal, selective mineralocorticoid receptor antagonist that has been shown in preclinical studies to block the harmful effects caused by overactivation of the mineralocorticoid receptor. Overactivation of the mineralocorticoid receptor is considered to lead to the progression of chronic kidney disease and cardiovascular damage through inflammation and fibrosis in target organs.