May 13th, 2014

A Second Darapladib Phase 3 Trial Misses Its Endpoint

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.

Last November GSK announced  that the STABILITY trial (STabilisation of Atherosclerotic plaque By Initiation of darapLadIb TherapY) had failed to meet its primary endpoint. In that trial darapladib was compared with placebo in more than 15,000 patients with chronic coronary heart disease. The main results of the trial were then presented in March at the American College of Cardiology meeting and published simultaneously in the New England Journal of Medicine.

GSK said that the two trials had uncovered “no major safety concerns” with the drug. But an ongoing issue has been that darapladib causes unpleasant odors in feces and urine in some people taking the drug. Darapladib was originally developed by Human Genome Sciences. It was a key reason why GSK acquired that company.

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