Top 5 Clinical Setbacks of 2014: GlaxoSmithKline’s darapladib.
Datamonitor Healthcare and SCRIP have paired up to select some of the biggest clinical study crashes to date this year. Over the week we’ll be reviewing our top five clinical trials that have been selected, kicking off with cardiovascular.
In May, novelty in the cardiovascular pipeline took a hit when GlaxoSmithKline’s darapladib failed in a Phase III study.
The investigational Lp-PLA 2 inhibitor missed its primary endpoint in the SOLID-TIMI 52, 13,000-patient trial, putting the final nail in the coffin for this class of therapies. This investigational class targeted Lp-PLA2 (lipoprotein-associated phospholipase A2), an inflammatory enzyme found in blood and atherosclerotic plaques. Elevated Lp-PLA2 activity had been implicated in the development and progression of atherosclerosis.
Darapladib’s previous nearest competitor, Anthera Pharmaceuticals’ varespladib, was discontinued in Phase III because of lack of efficacy in atherosclerosis in 2012.
SOLID-TIMI 52’s primary endpoint was reduction of major coronary events, versus placebo when added to standard of care in adults following an acute coronary syndrome (starting within 30 days).
The death knell was sounded back in March, when GSK presented the full results of the first major Phase III trial of the darapladib, STABILITY, in patients with stable coronary heart disease, which also failed back in November 2013.
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