Darapladib mesylate fails to meet endpoint in ACS Phase III trial-GSK
GlaxoSmithKline announced headline results from its second Phase III study with darapladib mesylate, SOLID-TIMI 52, evaluating the efficacy of its investigational Lp-PLA2 inhibitor in adults following an Acute Coronary Syndrome. In the study, darapladib did not achieve the primary endpoint of a reduction of major coronary events versus placebo when added to standard of care.
The overall safety profile for darapladib showed no major safety concerns and was generally consistent with the safety data seen in the previously reported Phase III study, STABILITY. Further analysis of the data is ongoing. Darapladib is not approved for use anywhere in the world.
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