British pharma giant GlaxoSmithKline plc (GSK.L,GSK) announced top-line results from the Phase III STABILITY trial, assessing the efficacy of its investigational Lp-PLA2 inhibitor darapladib in adults with chronic coronary heart disease. Darapladib is not approved for use anywhere in the world.
The study failed to meet the primary endpoint measure, which was time to first occurrence of any major adverse cardiovascular event from the composite of myocardial infarction, stroke, and cardiovascular death. There were greater reductions in some of the pre-defined secondary endpoints that require further analysis. Additional data would be forthcoming from the second Phase III study, SOLID-TIMI 52.
In STABILITY, the overall safety profile demonstarted no major imbalance in serious adverse events between the active and placebo groups. Frequently reported adverse events included diarrhoea and odour which occurred at a similar frequency to that seen in Phase II. Further analysis of the data is ongoing.
Patrick Vallance, President of Pharmaceuticals R&D, said: "Given the level of patient need in this area, we continue to investigate the role of Lp-PLA2 inhibition in coronary heart disease and other diseases. We will now work to better understand the data, including evaluation of the patient sub-groups, and await the outcome of a second Phase III study of darapladib in acute coronary syndrome, called SOLID-TIMI 52, to determine our next steps."
The complete results of the STABILITY trial would be submitted for presentation at a scientific meeting in 2014.
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