GSK announces start of phase III cardiovascular outcomes study with losmapimod in patients with acute coronary syndrome

Issued: London UK

GlaxoSmithKline plc (LSE/NYSE: GSK) today 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.

Acute coronary syndrome is a term used to describe situations or events, including heart attack, where there is an abrupt reduction of blood flow to the heart through the coronary arteries. Presentation by a patient with acute coronary syndrome is a manifestation of coronary heart disease.

Losmapimod is an inhibitor of p38 mitogen activated protein (MAP) kinase, an enzyme understood to play a central role in the acute inflammation that occurs during a heart attack.

Dr. John Lepore, Senior Vice President of Metabolic Pathways and Cardiovascular R&D at GSK, commented:

“Although changes in diet and lifestyle along with new approaches to treatment have led to improved outcomes for patients with coronary artery disease, patients who suffer a heart attack remain at increased risk of a recurrent heart attack or other vascular event in the ensuing weeks and months.  The start of our losmapimod study is an important step forward in the search for innovative therapies aimed at reducing the recurrence of cardiovascular events.”

About the LATITUDE-TIMI 60 study

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) 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.

About losmapimod and p38 MAP kinase

Losmapimod is an anti-inflammatory 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 that occurs in the blood vessels during and immediately after an acute coronary syndrome.

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.

Losmapimod is designed as a short-term treatment to be administered as quickly as possible after an acute coronary syndrome (specifically, a heart attack) and for a period of 12 weeks thereafter, when the patient is most at risk of a further major cardiovascular event.

GSK – one of the world’s leading research-based pharmaceutical and healthcare companies – is committed to improving the quality of human life by enabling people to do more, feel better and live longer.  For further information please visit www.gsk.com.

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 2013.