Merck has reported that the Phase III VICTORIA clinical trial of vericiguat met its primary efficacy endpoint in patients suffering from worsening chronic heart failure with reduced ejection fraction (HFrEF).
Vericiguat is a stimulator of soluble guanylate cyclase (sGC) that is being co-developed by Merck and Bayer.
The VICTORIA trial assessed the drug in a total of 5,050 HFrEF patients after a decompensation event/heart failure hospitalisation or taking an intravenous diuretic for heart failure without hospitalisation.
During the trial, a once-daily dose of the drug was compared to placebo when given with existing heart failure therapies.
The primary endpoint is the composite of time to the first occurrence of cardiovascular death or heart failure hospitalisation.
Secondary endpoints include time to first heart failure hospitalisation and time to occurrence of cardiovascular death. It also includes time to total heart failure hospitalisations, the composite of all-cause mortality or heart failure hospitalisation and all-cause mortality.
The trial met the primary goal, with vericiguat mitigating the risk of the composite endpoint of heart failure hospitalisation or cardiovascular death, compared to placebo.
Merck Research Laboratories senior vice-president and global clinical development head Dr Roy Baynes said: “VICTORIA is the first large contemporary outcomes study to focus exclusively on a population with worsening chronic heart failure who have a high risk for cardiovascular mortality and repeated heart failure hospitalisations.
“We are pleased vericiguat met this primary endpoint and look forward to sharing the detailed findings of the study.”
Merck and Bayer co-sponsored the Phase III trial, which was conducted in alliance with Canadian VIGOUR Centre and the Duke Clinical Research Institute at more than 600 sites in 42 countries.
The companies entered a global collaboration in October 2014 for the development of sGC modulators.