November 12th, 2013

Promising GSK Heart Drug Misses Primary Endpoint in 15,000-Patient Trial

GlaxoSmithKline announced today that the first of two pivotal phase 3 trials with a new drug, darapladib, had failed to meet its primary endpoint. Full results of the trial will be presented at a scientific meeting.

The STABILITY trial (STabilisation of Atherosclerotic plaque By Initiation of darapLadIb TherapY) tested the effect of darapladib, an investigational Lp-PLA2 inhibitor, in more than 15,000 patients with chronic coronary heart disease. GSK reported a nonsignificant 6% relative risk reduction associated with the use of darapladib (versus placebo) in the time to first occurrence of any major adverse cardiovascular event (the composite of myocardial infarction, stroke, and cardiovascular death).

The company said there were statistically significant reductions “in some of the pre-defined secondary endpoints that require further analysis.” The company reported “no major imbalance in serious adverse events” in the trial but noted that diarrhea and odor “occurred at a similar frequency to that seen in Phase II.”

Darapladib is an oral inhibitor of Lp-PLA2 (lipoprotein-associated phospholipase A2), an inflammatory marker associated with atherosclerosis and plaque rupture. GSK said that a second phase 3 trial, SOLID-TIMI 52, which is testing the effect of darapladib in more than 13,000 patients with acute coronary syndromes, will continue and will help the company “determine our next steps.”

GSK took over the development of darapladib when it acquired Human Genome Sciences last year.

One Response to “Promising GSK Heart Drug Misses Primary Endpoint in 15,000-Patient Trial”

  1. Vaughn Payne, MD, MBA, FACC says:

    Very disappointing. Stabilizing plaque is the current Holy Grail. In addition pharma needs a blockbuster category.