GSK heart trial misses primary endpoint
GlaxoSmithKline’s phase 3 clinical trial of its chronic coronary heart disease drug did not meet the primary endpoint measures.
The STABILITY (STabilisation of Atherosclerotic plaque By Initiation of darapLadIbTherapY) trial was evaluating the efficacy of its investigational Lp-PLA2 inhibitor darapladib in adults with chronic coronary heart disease (CHD).
The study did not meet the primary endpoint measure, which was time to first occurrence of any major adverse cardiovascular event (MACE) from the composite of myocardial infarction (heart attack), stroke, and cardiovascular death.
“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.”
Patrick Vallance, President of Pharmaceuticals R&D.
Darapladib is not approved for use anywhere in the world. Data from this study will contribute to any future regulatory submissions for darapladib. Full results of the STABILITY study will be submitted for presentation at a scientific meeting in 2014.
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