Date: 2014-06-05
Type of information: Initiation of the trial
phase: 3
Announcement: initiation of the trial
Company: GSK (UK)
Product: losmapimod
Action
mechanism: Losmapimod is an orally available, p38 mitogen-activated protein kinase inhibitor. p38 MAPK is a serine/threonine protein kinase which is required in the biosynthesis of tumour necrosis factor-α (TNFα) and interleukin-1 (IL-1). Inhibitors of p38 MAP kinase are therefore potential blockers of the secretion of these pro-inflammatory cytokines. For cardiovascular disease, studies have demonstrated several key biological functions of p38 MAP kinase in the coronary vessel wall and in the myocardium, which make p38 MAP kinase inhibition a potentially important therapeutic approach in acute coronary syndrome. Evidence to date suggests that p38 MAP kinase inhibition may potentially attenuate the inflammatory processes in the vascular wall, improve vascular function and prevent subsequent thrombosis, thereby potentially reducing the risk of subsequent plaque rupture and cardiac events.
Disease: acute coronary syndrome
Therapeutic area: Cardiovascular diseases
Country:
Trial
details: LATITUDE-TIMI 60 (LosmApimod To Inhibit p38 MAP kinase as aTherapeUtic target and moDify outcomes after an acute coronary syndrome-Thrombolysis InMyocardial Infarction 60; NCT02145468) is a randomised, double-blind, placebo-controlled, multi-centre study across 39 countries. It is anticipated that a total of 25,500 patients will be enrolled over the study period. Eligible patients presenting with acute coronary syndrome (specifically, a heart attack) will be 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 is 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 is cardiovascular death and myocardial infarction. Other composite secondary endpoints include those which examine hospitalisation for heart failure and stroke.
The LATITUDE-TIMI 60 study is being conducted in collaboration with the TIMI Study Group, Brigham and Women\'s Hospital, Boston, Massachusetts. (NCT02145468)
Latest
news: * On June 5, 2014, GSK announced the start of a pivotal phase III study, LATITUDE-TIMI 60, to evaluate the effects of losmapimod in patients presenting with acute coronary syndrome. The global, phase III study will assess whether losmapimod can reduce the risk of a subsequent cardiac event when administered orally twice a day for a period of three months immediately after presentation with an acute coronary syndrome. It is anticipated that a total of 25,500 patients will be enrolled over the study period. Eligible patients presenting with acute coronary syndrome (specifically, a heart attack) will be 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 LATITUDE-TIMI 60 study is being conducted in collaboration with the TIMI Study Group, Brigham and Women\'s Hospital, Boston, Massachusetts.
