Second pivotal Phase 3 trial to evaluate investigational Lp-PLA2 inhibitor darapladib initiated

Dec 10 2009

Attached is a press release issued earlier this morning by GlaxoSmithKline, announcing that GSK has initiated its second pivotal Phase 3 trial to evaluate the efficacy of long-term treatment with the investigational Lp-PLA₂ inhibitor darapladib in men and women with acute coronary syndrome (ACS). GSK announced the initiation of its first pivotal trial of darapladib in December 2008.

Darapladib was discovered by GSK based on HGS technology. HGS will receive 10% royalties on worldwide sales if darapladib is commercialized, and has a 20% co-promotion option in North America and Europe.

GlaxoSmithKline today announced initiation of the second large-scale Phase III clinical trial to evaluate long-term treatment with the investigational Lp-PLA₂ inhibitor darapladib in men and women with acute coronary syndrome (ACS). The study, called SOLID-TIMI 52 (The Stabilisation of pLaque Using darapladib -Thrombolysis In Myocardial Infarction 52), will include 11,500 patients from 40 countries.

SOLID-TIMI 52 is a randomised, placebo-controlled, double-blind trial in men and women with ACS. The study will evaluate the clinical efficacy of long-term use of darapladib as compared with placebo when both are added to standard of care (which may include a statin, aspirin and blood pressure medications). The study will test whether darapladib affects the chances of having a cardiovascular event, such as a heart attack or stroke, when treatment is started within 30 days after an acute coronary syndrome.

“Because cardiovascular disease remains the world’s number one killer, new approaches to treatment are needed. Targeting and inhibiting the Lp-PLA₂ enzyme may reduce the risk of cardiovascular events in patients with heart disease,” said Patrick Vallance, MD, Senior Vice President, Drug Discovery, GlaxoSmithKline. “With more than 27,000 patients, the combined Phase III clinical programme for darapladib will be one of the largest ever conducted to evaluate the efficacy and safety of any cardiovascular medication”.

SOLID-TIMI 52 is the second pivotal Phase III trial to evaluate darapladib. The first large-scale trial, STABILITY, is studying darapladib in patients with chronic coronary artery disease. STABILITY was initiated in late 2008 and has completed enrollment ahead of schedule with more than 15,000 patients recruited.