The results of the Phase III VICTORIA trial set up the potential for the companies to seek regulatory approval for vericiguat.
A drug developed by both Merck and Bayer hit the mark in treating patients with worsening chronic heart failure. The results of the Phase III VICTORIA trial set up the potential for the companies to seek regulatory approval for vericiguat.
In a joint announcement this morning, the two companies did not provide complete trial data. They indicated that information would be shared at an upcoming medical conference. Bayer and Merck said vericiguat, a soluble guanylate cyclase (sGC) stimulator, met the primary endpoint by demonstrating a statistically significant reduction of the first occurrence of a composite of cardiovascular death or heart failure hospitalization. The trial was assessing the efficacy of the medication in those patients’ chronic heart patients with reduced ejection fraction (HFrEF). Vericiguat was being tested in combination with available heart failure therapies against placebo, the companies said. Bayer and Merck have been collaborating on the development of sGC modulators since 2014. Soluble guanylate cyclase is an enzyme that plays a key role in regulating pulmonary vascular tone.
The VICTORIA trial included more than 5,000 HFrEF patients who had been hospitalized for heart failure or received an intravenous diuretic for heart failure without hospitalization. In addition to the primary endpoint, the trial included secondary endpoints of time to occurrence of cardiovascular death, time to first occurrence of heart failure hospitalization, time to total heart failure hospitalizations time to the composite of all-cause mortality or heart failure hospitalization, and time to all-cause mortality. In the brief announcement this morning, the companies did not provide information on the secondary endpoints.
Roy Baynes, head of global clinical development and chief medical officer for Merck Research laboratories, said the VICTORIA trial is the first study to solely focus on a patient population with worsening chronic heart failure who have a high risk for cardiovascular mortality and repeated heart failure hospitalizations. Baynes said the research team was pleased that vericiguat met the primary endpoint in the Phase III study and added that they look forward to “sharing the detailed findings of the study” in the near future. The results of the VICTORIA study will be presented at an upcoming medical meeting in 2020.
It is estimated that heart failure impacts more than 60 million people across the globe, with about 6.5 million in the United States. Heart failure with reduced ejection fraction (HFrEF), which has been previously known as systolic heart failure, is characterized by the compromised ability of the heart to eject blood sufficiently during its contraction phase. Approximately 40% to 50% of heart failure patients in the U.S. are estimated to have HFrEF. Of those, about 30% will see their disease worsen, the companies noted. Hospitalization rates increase significantly for those patients and about 20% of these patients with worsening chronic HFrEF will die within two years, the companies noted.
Despite the advances in therapies and prevention efforts for heart failure, Joerg Moeller, head of research and development at Bayer, said cardiovascular events remain high across the world.
“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,” Moeller said in a statement.
