GSK's Darapladib Phase III Study In ACS Misses Primary Endpoint
GlaxoSmithKline announced that its second Phase III study SOLID-TIMI 52 with darapladib investigating the efficacy of Lp-PLA2 inhibitor in adult patients following an acute coronary syndrome did not meet its primary endpoint.
The study failed to reduce major coronary events compared to placebo when added to standard of care. Safety profile of the drug was consistent with those observed in the Phase III study STABILITY. However, the drug also failed to significantly reduce major adverse cardiovascular events compared to placebo in patients with chronic coronary heart disease. Primary endpoint measure in the SOLID-TIMI 52 (Stabilisation Of pLaques usIng Darapladib – Thrombolysis In Myocardial Infarction 52) study was time to first occurrence of any event from the composite of coronary heart disease death, myocardial infarction, and urgent coronary for myocardial ischemia.
Patrick Vallance, GSK’s President of Pharmaceuticals R&D, said, “We are disappointed that the outcome of this second phase III study with darapladib does not support a regulatory submission in atherosclerosis. Our phase III program for darapladib would not have been possible without the generous participation of more than 30,000 patients with coronary heart disease and their families, and we are most grateful for their participation. We will now work to further analyze the data and better understand the findings.”
Darapladib is a selective and orally active inhibitor of Lp-PLA2 (lipoprotein-associated phospholipase A2) under development as a potential therapeutic pathway for atherosclerosis. Lp-PLA2 is an enzyme in the blood and in atherosclerotic plaques. High activity levels of the enzyme are implicated in the development and progression of atherosclerosis, an inflammatory heart condition. The disease is characterized by the build-up of plaques, cholesterol, and other blockage material within artery walls. Rupture of the plaques lead to blockage of important blood vessels and lead to heart attacks and strokes.
The investigational drug darapladib is not approved for use anywhere around the world.