LONDON, Dec 18 (Reuters) - GlaxoSmithKline Plc (GSK.L) placed a big bet on a new type of medicine for clogged arteries on Thursday by launching a costly three-year clinical trial involving more than 15,000 patients worldwide.
The world’s second biggest drugmaker said it expected the Phase III study of darapladib to last about three years, with a second large trial involving around 12,000 subjects due to start in late 2009.
Glaxo wants to find out if patients live longer and have fewer heart attacks and strokes when given the drug.
The move comes at a time when other some large drugmakers are cutting back on developing new cardiovascular treatments.
Darapladib, which Glaxo discovered with Human Genome Sciences Inc HGSI.O, is the first in a new class of drugs targeting an enzyme called Lp-PLA2 which is linked to artery-clogging plaques.
It is designed to offer something above and beyond the hugely successful statin class of cholesterol-lowering treatments, by reducing the risk of plaques rupturing and blocking blood vessels, thereby triggering heart attacks.
UBS analysts estimate annual sales might eventually top 5 billion pounds ($7.7 billion) a year if the drug works. But the project remains high-risk and darapladib is still many years from reaching the market.
Glaxo’s decision to invest heavily in the new approach contrasts with a move this year by its biggest rival Pfizer Inc (PFE.N) to stop hunting for new drugs for heart disease.
“We are prepared to take a risk in an area where risk-taking is necessary if we’re going to change the treatment paradigm,” Patrick Vallance, Glaxo’s head of drug discovery, told Reuters.
He declined to comment on the exact cost of the Phase III trial programme but acknowledged it would be expensive.
For now, industry analysts are cautious about prospects for darapladib, with most carrying only modest sales forecasts for the product in financial models.
Mixed results from a Phase II clinical trial involving 330 patients, reported at a medical meeting in Munich in September, did little to persuade them that Glaxo has a sure-fire winner.
That study found darapladib prevented the expansion of the so-called necrotic core of arterial plaques, which can break up and block arteries.
But it failed to meet its primary goals of reducing the “deformability” of plaques and in cutting blood levels of an inflammatory marker called C-reactive protein, raising doubts about how useful the drug will be in clinical practice.
The new 15,000-patient study, called STABILITY, aims to answer this question by comparing darapladib to placebo when both are given on top of standard care that may include statins, aspirin and blood pressure medications in people with chronic coronary heart disease.
The trial will be stopped after approximately 1,500 cases of major adverse cardiovascular events are recorded, which Glaxo expects to take around three years.
A second large event-driven study of the drug in patients who have experienced acute coronary syndrome is scheduled to start in late 2009 and also last around three years.
Vallance said it was possible both trials might last longer than three years if event rates were slower than anticipated.
The lengthy trial programme means darapladib would not reach the market until well after generic versions of Pfizer’s blockbuster anti-cholesterol heart drug Lipitor — the world’s biggest selling prescription medicine — start flooding the market in 2011. (Editing by Jon Loades-Carter)