GlaxoSmithKline (GSK) has started a huge late-stage trial of its anti-inflammatory drug losmapimod in patients with acute coronary syndrome (ACS).
Losmapimod (formerly GW856553) is a selective inhibitor of the enzyme family known as p38 mitogen-activated kinase (MAK) and has been tested by GSK in a number of indications, including chronic obstructive pulmonary disease (COPD), neuropathic and back pain and even depression.
There are suggestions that the inflammatory response in ACS is integral to atherosclerotic plaque instability that can lead to rupture and heart attack, so dampening down this inflammation could have a protective effect.
John Lepore, GSK’s senior vice president of metabolic pathways and cardiovascular R&D, said the new study “is an important step forward in the search for innovative therapies aimed at reducing the recurrence of cardiovascular events.”
The phase III trial – called LATITUDE-TIMI 60 – will enrol more than 25,000 ACS patients who have just suffered a myocardial infarction (MI) and who will be randomised to receive three months of twice daily oral treatment with either losmapimod or placebo. The first 12 weeks after an MI tend to be when an ACS patient is at the most risk of a further major cardiovascular event.
After an initial in-hospital period, patients will return for outpatient visits at 4 and 12 weeks, as well as a follow up visit at 24 weeks.
The primary measure of efficacy will be a composite of major adverse cardiovascular events, including the time to cardiovascular death, MI, or severe recurrent ischemia requiring urgent coronary artery revascularisation.
“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,” said Lepore.
GSK’s cardiovascular pipeline suffered a setback last month when coronary artery disease therapy darapladib failed a second phase III trial.