GSK Pivotal Phase III Study of Darapladib in Chronic Coronary Heart Disease Gid Not Meet Primary Endpoint

GlaxoSmithKline

today announced top-line results from the Phase III STABILITY trial (STabilisation of Atherosclerotic plaque By Initiation of darapLadIb TherapY), evaluating the efficacy of its investigational Lp-PLA2 inhibitor darapladib in adults with chronic coronary heart disease (CHD). Darapladib is not approved for use anywhere in the world. 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 (relative risk reduction of 6%; p=0.199). There were greater reductions (nominal p<=0.05) in some of the pre-defined secondary endpoints that require further analysis. Additional data will be forthcoming from the second Phase III study, SOLID-TIMI 52. In STABILITY, the overall safety profile showed 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. Commenting on the results, 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. ”Full results of the STABILITY study will be submitted for presentation at a scientific meeting in 2014. The data from this study will contribute to any future regulatory submissions for darapladib.