GlaxoSmithKline tees up another huge cardio PhIII after darapladib flop

After a costly string of defeats with the heart drug darapladib, GlaxoSmithKline's ($GSK) cardio unit is rolling into Phase III with another cardiac hopeful, launching an expansive late-stage effort for losmapimod, designed to prevent repeat heart attacks.

GSK plans to enroll more than 25,000 patients around the globe in a double-blind trial, testing how well losmapimod can forestall major cardiovascular events (like another heart attack) in subjects with coronary heart disease. Patients will take losmapimod or placebo twice a day for three months, GSK said, and the company is looking at secondary endpoints of incidence of cardiovascular death and heart attack, and hospitalization for heart failure or stroke.

The oral drug is designed not as a maintenance therapy but as a short-term, as-quickly-as-possible solution for patients who have just endured a heart attack, a population that remains underserved, said John Lepore, GSK's head of cardio R&D.

"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," Lepore said in a statement.

GSK's return to staging colossal cardio outcomes studies comes after darapladib, once expected to be a blockbuster therapy, failed to significantly benefit patients in two Phase III trials involving more than 30,000 subjects. That drug was the star of GSK's $3 billion acquisition of Human Genome Sciences in 2012, a price tag painful to consider after its clinical performance.

Losmapimod, also in development for COPD, works by blocking an enzyme called p38 MAP, considered to play a main role in the acute inflammation that takes place during a heart attack. Shutting the enzyme down should relieve inflammation in the vascular wall, GSK said, thereby preventing blood clots and reducing the risk of plaque buildup and heart attack.

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