Pharmaprojects R&D Pipeline News Feed
Merck discontinues rolofylline following Phase III trial results
10 Jun 2009
Rolofylline (MK-7418) has failed to meet its primary and secondary efficacy endpoints in two Phase III trials (PROTECT-1 and PROTECT-2) across a total of 2,034 patients for the treatment of acute heart failure. The adenosine A1 receptor antagonist, under development by Merck & Co. and Kyowa Hakko Kirin, was previously expected to be filed for regulatory approval this year.
Results from PROTECT-1, an efficacy trial in 932 patients with acute heart failure and renal impairment across sites in the EU, Canada, Russia, Israel and the US, showed it failed to meet the primary or secondary endpoints of effect on heart failure signs and symptoms and effect on renal function and safety. Similar results were observed in PROTECT-2, a European study in 1102 hospitalized patients with acute volume overload.
The setback for Merck follows the discontinuation of its Phase III cannabinoid 1 receptor agonist taranabant at the end of last year, and delayed NDA filing plans for telcagepant, its CGRP antagonist for the treatment of pain associated with migraine.
Other adenosine A1 antagonists under development for the treatment of heart failure include Biogen Idec and CV Therapeutics' lead compound BG-9928 (Adentri), currently in Phase III trials, and Solvay's SLV-320, which is in Phase II studies.
