November 21, 2019 — Merck announced the results from the Phase 3 VICTORIA Study evaluating the efficacy and safety of vericiguat, met the primary efficacy endpoint for reducing the risk of heart failure hospitalization and cardiovascular death in patients with worsening chronic heart failure with reduced ejection fraction (HFrEF). The new drug outperformed patients given a placebo in combination with available heart failure therapies.
Vericiguat is being jointly developed by Merck and Bayer AG. It is a soluble guanylate cyclase (sGC) stimulator being developed to treat patients with worsening chronic heart failure.
The drug company said the results of the VICTORIA study will be presented at an upcoming medical meeting in 2020.
“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 hospitalizations. We are pleased vericiguat met this primary endpoint and look forward to sharing the detailed findings of the study,” said Roy Baynes, M.D., Ph.D., senior vice president and head of global clinical development, chief medical officer, Merck Research Laboratories.
“Heart failure affects more than 60 million patients worldwide. Despite advances in therapies and prevention efforts, the cardiovascular event rates remain high,” said Joerg Moeller, M.D., member of the Executive Committee of Bayer AG's Pharmaceutical Division and head of Research and Development. “There is a high unmet need for new treatment options to reduce the risk of death and hospitalizations. We are pleased with the positive outcome with vericiguat as the first sGC stimulator evaluated in patients with worsening chronic heart failure with reduced ejection fraction.”
VICTORIA Trial Details
The VICTORIA study is a randomized, placebo-controlled, parallel-group, multi-center, double-blind, Phase 3 study of vericiguat versus placebo when given 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 heart failure hospitalization or receiving an intravenous diuretic for heart failure 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 who were randomized to receive either vericiguat once daily (titrated up to 10 mg) or placebo when given 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.
What is 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.
For more information: www.merck.com