Vericiguat Hits Primary Clinical-Efficacy Endpoint in HFrEF

Megan Brooks

November 18, 2019

The investigational oral soluble guanylate-cyclase (sGC) stimulator vericiguat (Bayer/Merck), under development for treating worsening chronic heart failure (HF), met the primary efficacy endpoint in the phase 3 VICTORIA study, topline results show.

Vericiguat was associated with a reduced risk for the composite endpoint of HF hospitalization or cardiovascular death in patients with worsening chronic HF with reduced ejection fraction (HFrEF) compared to placebo when given in combination with standard HF therapies, Merck said in a press release.

"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," Roy Baynes, MD, PhD, chief medical officer, Merck Research Laboratories, said in the release.

The study enrolled 5050 patients who were randomly assigned to receive either vericiguat once daily, with titration up to 10 mg, or placebo in combination with other HF therapies.

The study, which was cosponsored by Merck and Bayer, was conducted in collaboration with the Canadian VIGOUR Center and the Duke Clinical Research Institute in more than 600 centers in 42 countries.

Secondary endpoints, for which data have yet to be reported, include time to occurrence of cardiovascular death, time to first occurrence of HF hospitalization, time to total HF hospitalizations (including first and recurrent events), time to the composite of all-cause mortality or HF hospitalization, and time to all-cause mortality.

Full results of the VICTORIA study will be presented at a medical meeting in 2020, the statement notes.

"There is a high unmet need for new treatment options to reduce the risk of death and hospitalizations" in HF, Joerg Moeller, MD, head of research and development at Bayer AG's pharmaceutical division, said in the news release. "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."

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