Merck has announced the results for the pivotal phase-III study of rolofylline (MK-7418), the investigational medicine for the treatment of acute heart failure. The results showed that rolofylline did not meet the primary or secondary efficacy endpoints.
While Merck will continue to analyze the data with outside experts, the company will not file applications for regulatory approval this year. The results from this study will be presented at a medical meeting later this year.
Rolofylline was acquired by Merck through NovaCardia, which Merck purchased in 2007.
Dan Bloomfield, Executive Director of cardiovascular research at Merck Research Laboratories, said: Advances to help patients with acute heart failure, a disease that is the leading cause of hospitalization for patients over age 65 and that is associated with a high rate of mortality, have long been elusive.
These results are disappointing because we had been hopeful that blocking the adenosine A1 receptor with rolofylline would prove to be a useful new approach for these patients,” he added.