The FINANCIAL — GSK on October 27 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, according to GSK.
GSK will assess these findings over the next few months to evaluate all options for future development.
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