Merck’s Rolofylline Misses Endpoint

Merck’s preliminary results for the Phase III study of rolofylline (MK-7418), an investigational medicine for the treatment of acute heart failure, shows that the drug did not meet the primary or secondary efficacy endpoints. The company will continue to analyze the data with outside experts, however it will not file applications for regulatory approval this year. Results from this study will be presented at a medical meeting later this year.

The 2,033-patient Phase III study, PROTECT, was designed to show that rolofylline 30 mg would improve symptoms of acute heart failure compared to placebo. The secondary endpoints were that rolofylline 30 mg would reduce the risk of death or cardiovascular or renal re-hospitalization 60 days after treatment, and that rolofylline 30 mg would reduce the incidence of persistent kidney impairment.

“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,” said Dan Bloomfield, M.D., executive director, cardiovascular research, Merck Research Laboratories. “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.