Merck has said that the preliminary results for its pivotal Phase III study of rolofylline (MK-7418), its investigational medicine for the treatment of acute heart failure, did not meet the primary or secondary efficacy endpoints in patients with heart failure.
While the Whitehouse Station, N.J.-based Merck said it will continue to analyze the data with outside experts, it will not file applications for regulatory approval this year. The results from this study will be presented later this year.
"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," said Dan Bloomfield, MD, executive director, cardiovascular research at Merck Research Laboratories.
The primary hypothesis of the 2,033-patient pivotal phase III study, PROTECT, was 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.
Rolofylline was acquired by Merck through the San Diego-based NovaCardia, which Merck purchased in 2007. Results from the PROTECT pilot study, presented at previous medical meetings and published in 2008, had shown an overall trend toward efficacy (more patients with improved shortness of breath, fewer patients with worsening renal function and/or worsening heart failure), according to the company.