Portola Pharmaceuticals has announced positive Phase II study results for elinogrel, its investigational anti-platelet drug, which is intended to treat chronic coronary heart disease and acute coronary syndrome.
The Phase II study comprised of a randomised, double-blind, multi-centre trial involving 650 patients who were undergoing non-urgent percutaneous coronary intervention. It evaluated intravenous and oral elinogrel compared to clopidogrel, in addition to standard of care.
The study was designed to evaluate multiple endpoints, including anti-platelet activity, and the safety and tolerability of elinogrel in doses of 80/120mg intravenously, followed by doses of 100/150mg orally, for a period of 60 to 120 days.
The results showed that elinogrel demonstrated a rapid and greater anti-platelet effect than clopidogrel (300-600mg).
There were no TIMI major bleeding events during the 24-hour phase in either the 100mg or 150mg doses.
Dr Daniel Gretler, Portola's chief medical officer, said that the results showed that elinogrel had a desirable pharmacodynamic and tolerability profile worthy of further investigation.
The company plans to initiate a Phase III study of the drug in the first quarter of 2011.
