Phase III study with Lp-PLA2 inhibitor darapladib did not meet primary endpoint
The SOLID-TIMI 52 trial, evaluating the efficacy of the investigational Lp-PLA2 inhibitor darapladib in adults following an acute coronary syndrome, did not achieve the primary endpoint of a reduction of major coronary events as compared with placebo, when added to standard of care. The primary endpoint was time to first occurrence of any event from the composite of coronary heart disease death, myocardial infarction (MI) and urgent coronary revascularisation for myocardial ischemia.
Elevated Lp-PLA2 (lipoprotein-associated phospholipase A2) activity has been implicated in the development and progression of atherosclerosis. Darapladib is a selective and orally active inhibitor of Lp-PLA2.
In SOLID-TIMI 52, darapladib was tested as a long-term therapy in patients within 30 days of an acute coronary syndrome. The randomised, placebo-controlled, double-blind, parallel group multi-centre study enrolled more than 13,000 patients across 36 countries.
SOLID-TIMI 52 (Stabilisation Of pLaques usIng Darapladib – Thrombolysis In Myocardial Infarction 52) is the second of two event-driven phase III studies with darapladib in coronary heart disease. STABILITY, the first phase III study, had shown that darapladib did not achieve a statistically significant reduction in the primary endpoint of major adverse cardiovascular events (CV death, MI and stroke), when compared with placebo in patients with chronic coronary heart disease.
The overall safety profile for darapladib showed no major safety concerns and was generally consistent with the safety data seen in STABILITY.
Full results of the SOLID-TIMI 52 study will be presented at a scientific meeting.
Press release GlaxoSmithKline 13 May 2014