Primary efficacy endpoint not met with anti-inflammatory agent in patients with ACS


News - Oct. 28, 2015

An interim review of data from part A of the phase III LATITUDE-TIMI 60 study evaluating losmapimod did not indicate efficacy against the primary endpoint. Part A consisted of an initial cohort of 3503 patients. These data do not support investment in the larger part B of the study as currently designed. 

LATITUDE-TIMI 60 (LosmApimod To Inhibit p38 MAP kinase as a TherapeUtic target and moDify outcomes after an acute coronary syndrome-Thrombolysis In Myocardial Infarction 60; NCT02145468) was a randomised, double-blind, placebo-controlled, multi-centre study across 39 countries. In Part A of the study, 3503 patients presenting with acute coronary syndrome (ACS) were randomised to receive three months of twice daily oral treatment with either 7.5mg of losmapimod or placebo in addition to standard of care.

Losmapimod is an anti-inflammatory agent that inhibits the activity of p38, a mitogen-activated protein kinase, an enzyme that is associated with the acute inflammation and cellular injury that occurs in the blood vessels and in the heart during and immediately after an ACS.

The primary efficacy endpoint of the study was the composite measure of adjudicated major adverse cardiovascular events, comprising the time to first occurrence of cardiovascular death, myocardial infarction, or severe recurrent ischemia requiring urgent coronary artery revascularization. The key secondary endpoint of the trial was cardiovascular death and myocardial infarction. Other composite secondary endpoints include those which examine hospitalisation for heart failure and stroke.

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. Specifically, statistically nonsignificant 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. The number of events (n=59) was relatively low.  

The study’s stepwise approach was designed with input from academic organisations to enable a phase III scale study to begin, but with an interim review to assess safety and gain insights on efficacy before continuing on the major second part of the study. Full results from Part A of the LATITUDE-TIMI 60 study will be submitted for presentation at a scientific meeting. Glaxo Smith Kline will assess these findings over the next few months to evaluate all options for future development. 
 Press release Glaxo Smith Kline October 27 2015

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