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Darapladib fails to meet primary endpoint in SOLID-TIMI 52 trial
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GlaxoSmithKline today announced that the Lp-PLA2 inhibitor darapladib failed to meet the primary endpoint in the phase 3 SOLID-TIMI 52 study.
The randomized, double blind, multicenter, international SOLID-TIMI 52 study was designed to assess the efficacy of darapladib as a long-term therapy within 30 days of ACS. Researchers enrolled more than 13,000 patients, according to a press release.
The primary endpoint was time to first occurrence of MI, urgent coronary revascularization due to myocardial ischemia or CHD-related death. The trial was the second of two studies of darapladib. In the phase 3 STABILITY trial, darapladib did not significantly reduce the incidence of stroke, MI or CV-related death compared with placebo among patients with chronic CHD.
Safety data from the SOLID-TIMI 52 study were similar to that observed in STABILITY, and no major safety issues were observed, according to the release.
“We are disappointed that the outcome of this second phase 3 study with darapladib does not support a regulatory submission in atherosclerosis,” Patrick Vallance, president of pharmaceuticals research and development for GlaxoSmithKline, stated in the release. “… We will now work to further analyze the data and better understand the findings.”
The company will present the full results from SOLID-TIMI 52 at a future scientific meeting.