Merck and Bayer announced positive results from the Phase 3 VICTORIA study evaluating vericiguat for the treatment of patients with worsening chronic heart failure. The trial met the primary efficacy endpoint: Vericiguat reduced the risk of the composite endpoint of heart failure hospitalization or cardiovascular death in patients with worsening chronic heart failure with reduced ejection fraction (HFrEF) compared to placebo. Vericiguat is being jointly developed with Bayer AG.
VICTORIA was a randomized, placebo-controlled, parallel-group, multi-center, double-blind study in 5,050 patients with worsening chronic HFrEF following a decompensation event, defined as heart failure hospitalization or receiving an intravenous diuretic for heart failure without hospitalization. The patients were randomized to receive either vericiguat once daily (titrated up to 10 mg) or placebo given in combination with available heart failure therapies. The primary endpoint of the study was the composite of time to first occurrence of cardiovascular death or heart failure hospitalization.
Detailed results of the VICTORIA study will be presented at an upcoming medical meeting in 2020.
Vericiguat is a soluble guanylate cyclase (sGC) stimulator optimized for once-daily dosage. Beyond its vasodilatory properties, low dose sGC stimulation in preclinical models has been shown to also have direct antifibrotic effects, improving myocardial remodeling and diastolic relaxation in the absence of any hemodynamic effects.
About Heart Failure with Reduced Ejection Fraction
Heart failure with reduced ejection fraction (HFrEF), formerly known as systolic heart failure, is characterized by the compromised ability of the heart to eject blood sufficiently during its contraction phase. In the U.S., 6.5 million people have heart failure, and approximately 40-50% of these patients have HFrEF. Annually, approximately 30% of patients with symptomatic chronic heart failure will experience worsening of the disease, which is marked by progressive symptoms and/or a recent heart failure event. Approximately half of patients with worsening chronic HFrEF are rehospitalized within 30 days of the worsening event, and an estimated one in five patients with worsening chronic HFrEF will die within two years.