GSK Presents Data From STABILITY Trial Of Darapladib At ACC 14

GlaxoSmithKline announced that it has presented data from the pivotal Phase III STABILITY study of darapladib at the American College of Cardiology 63rd Annual Scientific Session in Washington, DC. The study results have also been published in the New England Journal of Medicine.

Dr. Murray Stewart, SVP, Metabolic Pathways Cardiovascular Therapy Area, said, “STABILITY was a robust, large-scale cardiovascular outcomes study of a novel mechanism with the goal of providing incremental benefit above a high level of standard of care. Given the unmet medical need, the results of the STABILITY study are important in understanding how this mechanism may impact the lives of patients with heart disease. We await the results of the second study, SOLID-TIMI 52, to better understand the findings.”

The double-blind, event-driven, global STABILITY (STtabilisation of Atherosclerotic plaque By Initiation of darapLadIb TherapY) trial randomized 15,828 patients with chronic coronary heart disease (CHD) to receive 160mg of darapladib or placebo once daily on a standard of care background. The study did not meet its primary endpoint, which was time to first occurrence of any major adverse cardiovascular event (MACE) comprising cardiovascular death, myocardial infarction (MI) and stroke. However, safety profile was well characterized in the large outcome study.

“In the STABILITY study, the lack of effect on stroke was disappointing but not unexpected given the emerging epidemiology data. While the study didn’t meet its primary endpoint, the effects of darapladib on the reduction of coronary events are of potential interest. These findings take us a step further towards defining which patients may benefit from treatment with darapladib,” said Dr. Harvey White, Director of Coronary Care Unit, Green Lane Cardiovascular Unit, Auckland City Hospital in New Zealand, and the co-chair of the STABILTY study.

Darapladib is a selective, orally active inhibitor of Lp-PLA2 (lipoprotein-associated phospholipase A2) under investigation as a potential agent to reduce cardiovascular events in patients with coronary heart disease. Lp-PLA2 is an enzyme found in blood and in atherosclerotic plaques. The drug is not yet approved for use anywhere in the world.