Darapladib Fails in Large Phase 3 Study

November 12, 2013

LONDON, UK – A large phase 3 study testing an inhibitor of the lipoprotein-associated A2 (Lp-PLA2) enzyme has failed to lower the risk of cardiovascular events in coronary heart disease patients who received the drug on top of statin therapy[1].

The Lp-PLA2 inhibitor darapladib (GlaxoSmithKline, London, UK) was tested in more than 15 000 patients in the Stabilization of Atherosclerotic Plaque by Initiation of Darapladib Therapy (STABILITY) study.

The trial ran to completion, but GlaxoSmithKline announced the top-line results today, stating the drug failed to provide a significant reduction in the risk of cardiovascular death, nonfatal MI, or nonfatal stroke when compared with patients treated with placebo.

In 2008, heartwire reported that darapladib failed to improve measures of plaque stability in an intravascular ultrasound (IVUS) study known as Integrated Biomarkers and Imaging Study .

Announcing the results today, GlaxoSmithKline said it plans to review the data and noted there was a treatment effect in some of the prespecified secondary end points. The company said it plans to wait for data from the Stabilization of Plaques Using Darapladib—Thrombolysis in Myocardial Infarction 52 (SOLID-TIMI 52) study in acute coronary syndrome patients before deciding what to do with the drug's development. Results of SOLID-TIMI 52 are expected in the first half of 2014.

In 2012, Anthera Pharmaceuticals stopped a phase 3 trial with its secretory PLA2 (sPLA2) inhibitor, varespladib , when it failed to provide a benefit in acute coronary syndrome patients treated with a background of statin therapy.


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