Merck said that its orally administered soluble guanylate cyclase (sGC) stimulator vericiguat met the primary efficacy endpoint in the phase 3 VICTORIA trial in heart failure patients.
Compared to placebo, vericiguat in combination with available heart failure therapies, significantly cut down the risk of heart failure hospitalisation or cardiovascular death, which was the primary endpoint of the late-stage trial. This was achieved in patients having worsening chronic heart failure with reduced ejection fraction (HFrEF).
Merck said that a hazard ratio of 0.90 in the high-risk population converted into a clinically relevant 4.2/100 patient-years absolute reduction in event rate. The company said that based on the absolute risk reduction, the number required for treatment with vericiguat for a year to prevent a primary outcome event is nearly 24 patients.
The sGC stimulator is being developed for the treatment of patients with heart failure with reduced ejection fraction and following a worsening incident.
According to Merck, VICTORIA is the first contemporary outcomes trial, which is exclusively focused on symptomatic chronic heart failure patients following a worsening event. The investigational drug is being developed jointly with Bayer.
The late-stage study featured 5,050 patients having high risk of hospitalisation and cardiovascular death after facing a recent heart failure decompensation.
Secondary endpoints of the VICTORIA trial include time to occurrence of cardiovascular death, time taken to first occurrence of heart failure hospitalisation, and time to total heart failure hospitalisations among others.
Merck Research Laboratories chief medical officer and global clinical development senior vice president and head Roy Baynes said: “VICTORIA builds on Merck’s strong legacy of conducting large cardiovascular outcomes studies designed to answer meaningful questions.
“By enrolling patients receiving heart failure therapy following intervention for a worsening event such as rehospitalization or urgent outpatient treatment, VICTORIA was designed to study a serious medical problem not studied in any other recent heart failure outcomes study.”
Merck and Bayer will look to share data from the VICTORIA trial with regulatory authorities across the world.