Primary endpoint met in drug study for worsening chronic heart failure

Merck has announced that the Phase III VICTORIA study evaluating the efficacy and safety of vericiguat, a soluble guanylate cyclase (sGC) stimulator being developed to treat patients with worsening chronic heart failure, has met the primary efficacy endpoint.

Vericiguat reduced the risk of the composite endpoint of heart failure hospitalisation or cardiovascular death in patients with worsening chronic heart failure with reduced ejection fraction (HFrEF) compared to placebo when given in combination with available heart failure therapies.

“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,” said Dr Roy Baynes, Senior Vice President and Head of Global Clinical Development, Chief Medical Officer, Merck Research Laboratories. “We are pleased vericiguat met this primary endpoint and look forward to sharing the detailed findings of the study.”

VICTORIA is a randomised Phase III study of vericiguat versus placebo when given in combination with available heart failure therapies in patients with worsening chronic HFrEF following a decompensation event, defined as heart failure hospitalisation or receiving an intravenous diuretic for heart failure without hospitalisation. The primary endpoint of the study is the composite of time to first occurrence of cardiovascular death or heart failure hospitalisation.

HFrEF is characterised by the compromised ability of the heart to eject blood sufficiently during its contraction phase. Approximately half of patients with worsening chronic HFrEF are rehospitalised within 30 days of the worsening event.

“Heart failure affects more than 60 million patients worldwide. Despite advances in therapies and prevention efforts, the cardiovascular event rates remain high,” added Dr Joerg Moeller, 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 hospitalisations.

“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.”

Vericiguat is being jointly developed with Bayer AG.