GSK launches huge Phase III trial for heart drug losmapimod

GlaxoSmithKline has begun a Phase III study cardiovascular outcomes study of its investigational compound losmapimod in patients with acute coronary syndrome.

The trial will assess whether losmapimod can reduce the risk of a subsequent cardiac event when administered orally twice a day for three months immediately after presentation with an ACS, such as heart attack. GSK says that some 25,500 patients will be enrolled over the study period across 39 countries.

Losmapimod is an anti-inflammatory that works by inhibiting the activity of p38, a mitogen-activated protein kinase. The latter is a type of enzyme associated with the acute inflammation that occurs in the blood vessels during and immediately after an ACS.

ohn Lepore, head of metabolic pathways and cardiovascular R&D at GSK, noted that changes in diet and lifestyle, “along with new approaches to treatment, have led to improved outcomes for patients with coronary artery disease”. However, 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”, he added, claiming that “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”.

The push on lospamimod comes less than a month after another heart drug, darapladib, failed to show efficacy in a second Phase III trial.