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Darapladib misses primary endpoint in phase 3 study
Darapladib, a novel Lp-PLA2 inhibitor, did not meet the primary endpoint in the phase 3 STABILITY trial, according to an announcement from GlaxoSmithKline.
The STABILITY study evaluated the efficacy of darapladib in adults with CHD. According to a company press release, the primary outcome of the STABILITY study is time to first occurrence of any major adverse CV event — defined as MI, stroke and CV death — in patients assigned darapladib compared with patients assigned placebo.
There was no significant difference between the groups in the primary endpoint (P=.199), although there were greater reductions (nominal P≤.05) in some pre-defined secondary endpoints, according to the press release. The company stated that those endpoints are undergoing further analysis.
The data also revealed no major differences in safety outcomes between the two groups. The most frequently reported adverse events were diarrhea and odor, which occurred in similar rates to phase 2 studies of darapladib, according to the press release.
Another phase 3 study, SOLID-TIMI 52, is evaluating darapladib for efficacy in adults with ACS. Data from that study are forthcoming, according to the press release.
Full results of STABILITY will be submitted for presentation at a scientific meeting in 2014, according to the press release.