GSK gambles on massive heart drug trial

While other companies are cutting back, GlaxoSmithKline is ramping up. The drugmaker announced on Thursday that it is initiating the first Phase III clinical trial for an investigational Lp-PLA2 inhibitor. The first in class darapladib is designed to target enzymes linked to plaque that clogs arteries. The study--dubbed STABILITY--will include more than 15,000 men and women from 39 countries. It will test whether darapladib reduces the risk of heart attack and stroke by preventing plaque ruptures, is expected to last three years.

GSK is gambling on a drug that showed mixed results in mid-stage trials. The trial failed to meet its primary end point of reducing the "deformability" of plaques and cutting blood levels of the C-reactive protein, an inflammatory marker. But data on the 330 patients involved in the IBIS-2 study showed that darapladib prevented the expansion of the necrotic core within coronary artery plaques, which can rupture and cause heart attacks and cardiovascular death.

Rival Pfizer cut its heart research program earlier this year, but GSK says it's ready to take the risk in expanding its program. "We are prepared to take a risk in an area where risk-taking is necessary if we're going to change the treatment paradigm," said Patrick Vallance, head of drug discovery. Although approval is years away, the risk could pay off big. Sales could reach $7.7 billion, UBS analysts tell Pharmalot.

- see GSK's release
- read the Pharmalot post