Bayer and Merck & Co. reported Monday that a Phase III study of the investigational therapy vericiguat in patients with worsening chronic heart failure with reduced ejection fraction (HFrEF) met its primary endpoint. Results from the VICTORIA trial showed that the soluble guanylate cyclase (sGC) stimulator reduced the risk of the composite endpoint of heart failure hospitalisation or cardiovascular death compared to placebo when given in combination with available heart failure therapies.
Roy Baynes, head of global clinical development at Merck Research Laboratories, remarked "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." The companies noted that results from the trial, which was initiated in 2016, will be presented at a medical meeting next year.
The study randomised 5050 patients with worsening chronic heart failure with HFrEF following a decompensation event to receive either vericiguat once daily or placebo, both in combination with available heart failure therapies. The trial's primary endpoint is the composite of time to first occurrence of cardiovascular death or heart failure hospitalisation, while secondary goals include time to occurrence of cardiovascular death, time to first occurrence of heart failure hospitalisation, time to total heart failure hospitalisations, time to the composite of all-cause mortality or heart failure hospitalisation, and time to all-cause mortality.
In 2014, Merck entered a deal potentially worth up to $2.1 billion in the area of cardiovascular diseases to market and develop Bayer's sGC modulators, including vericiguat. More recently, Bayer has estimated that if approved, vericiguat will bring in approximately €500 million ($553 million) in peak annual sales.
For related analysis, see ViewPoints: Bayer, Merck & Co.’s quiet confidence in vericiguat preliminarily pays off.
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