Phase III VICTORIA study with vericiguat in patients with worsening chronic heart failure meets primary endpoint.- Bayer + Merck Inc.

Bayer announced that the Phase III study VICTORIA (VerICiguaT glObal study in patients with heart failure with Reduced ejectIon frAction) evaluating the efficacy and safety of investigational vericiguat versus placebo, in combination with available heart failure therapies in patients with worsening chronic heart failure with reduced ejection fraction (HFrEF), has met the primary endpoint.

The findings demonstrate superiority of vericiguat in prolonging the time to first occurrence of the composite endpoint of cardiovascular death or heart failure hospitalization. Vericiguat is being jointly developed with Merck Inc..

VICTORIA is a randomized, placebo-controlled, parallel-group, multi-center, double-blind Phase III study investigating vericiguat versus placebo in combination with available heart failure therapies in patients with worsening chronic heart failure with reduced ejection fraction (HFrEF) following a decompensation event, defined as HF hospitalization or receiving an intravenous diuretic for HF without hospitalization. The primary endpoint of the study is the composite of time to first occurrence of cardiovascular death or heart failure hospitalization. Secondary endpoints include time to occurrence of cardiovascular death, time to first occurrence of heart failure hospitalization, time to total heart failure hospitalizations (including first and recurrent events), time to the composite of all-cause mortality or heart failure hospitalization, and time to all-cause mortality.

The study enrolled 5,050 patients with HFrEF who were randomized to receive either vericiguat once daily (titrated up to 10mg) or placebo in combination with available heart failure therapies. The study, which was co-sponsored by Merck and Bayer, was conducted in collaboration with the Canadian VIGOUR Centre and the Duke Clinical Research Institute in more than 600 centers in 42 countries including in Europe, Japan, China and the U.S. The clinical data from VICTORIA will be presented at an upcoming scientific meeting in 2020.