Losmapimod fails in Phase III trial (LATITUDE TIMI 60) to treat acute coronary syndrome-GSK
GSK announced that, as per the stepwise trial design of its losmapimod phase III study, LATITUDE-TIMI 60, an interim review of data from part A of the study (an initial cohort of 3,503 patients) did not indicate efficacy against the primary endpoint and did not support investment in the larger part B of the study as currently designed.
In the available data from this interim assessment, an efficacy signal in a sub-population of patients (n=866) classified with ST elevation myocardial infarction (STEMI) has been identified. Although not statistically significant, due to the relatively small number of events (n=59), reductions between 30% and 50% in the pre-specified endpoints of cardiovascular death, hospitalisation for heart failure, and the composite of the two were observed.