GSK said today that a large phase 3 trial of a once highly-promising drug had failed to meet its primary endpoint. Last year the company announced that another phase 3 trial with the same drug had failed. GSK said it would “further analyse the data and better understand the findings” but that, for now at least, it would not seek regulatory approval for the drug.
The SOLID-TIMI 52 (Stabilisation Of pLaques usIng Darapladib – Thrombolysis In Myocardial Infarction 52) trial randomized more than 13,000 patients within 30 days of an acute coronary syndrome to receive either placebo or darapladib, an anti-inflammatory drug designed to stabilize atherosclerotic plaques. GSK reported today that the drug did not significantly reduce major coronary events. The full results of the trial will be presented at a future scientific meeting.
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