GSK provides update on LATITUDE-TIMI 60 (losmapimod cardiovascular study)
GSK today 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.
Issued: London, UK
GSK today 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.
GSK will assess these findings over the next few months to evaluate all options for future development.
About the LATITUDE-TIMI 60 study
LATITUDE-TIMI 60 (LosmApimod To Inhibit p38 MAP kinase as aTherapeUtic 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, 3,503 patients presenting with acute coronary syndrome (specifically, a heart attack) 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.
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.
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.
About losmapimod and p38 MAP kinase
Losmapimod is an anti-inflammatory agent that works by inhibiting the activity of p38, a mitogen-activated protein kinase, which is a type of 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 acute coronary syndrome.
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Cautionary statement regarding forward-looking statements
GSK cautions investors that any forward-looking statements or projections made by GSK, including those made in this announcement, are subject to risks and uncertainties that may cause actual results to differ materially from those projected. Such factors include, but are not limited to, those described under Item 3.D 'Risk factors' in the company's Annual Report on Form 20-F for 2014.
