ACC 2014: GSK's darapladib disappoints in Ph III trial

UK pharma major GlaxoSmithKline (LSE: GSK) presented disappointing data from its pivotal Phase III STABILITY study of heart disease drug darapladib at the American College of Cardiology 63rd Annual Scientific Session in Washington DC yesterday.

The preliminary results were announced in November. Analysts at the time said that the product could have reached $10 billion in revenues if successful, forecasting a 2015 launch with hopes of significant upgrades from this product. The data have also been published in the New England Journal of Medicine. Darapladib is not approved for use anywhere in the world.

The global, double-blind, event-driven trial randomized 15,828 patients with chronic coronary heart disease (CHD) to receive 160mg of darapladib or placebo once daily on a background of standard of care. The primary endpoint was time to first occurrence of any major adverse cardiovascular event (MACE) comprising cardiovascular death, myocardial infarction (MI) and stroke. Secondary endpoints included major coronary events (MCE) comprising CHD death, MI or urgent coronary revascularisation for myocardial ischemia; total coronary events comprising CHD death, MI, hospitalization for unstable angina or any coronary revascularization procedure; the individual components of MACE; and all-cause mortality.