GSK heart disease drug fails late-stage trial
pharmafile | November 13, 2013 | News story | Sales and Marketing | GSK, darapladib, heart, statin
GSK has said its investigational chronic coronary heart disease pill darapladib has failed to meet its primary endpoint in a Phase III trial.
The treatment was not found to significantly reduce the risk of stroke or heart attack in a study that tracked more than 15,000 participants over nearly five years.
GSK’s R&D president Patrick Vallance remained optimistic about the news, indicating that some patient sub-groups displayed positive results in the trial.
“Given the level of patient need in this area, we continue to investigate the role of Lp-PLA2 inhibition in coronary heart disease [and] will now work to better understand the data.”
The drug is designed for patients taking cholesterol-lowering statins that are not performing as expected or having the desired effect. Darapladib combats heart disease by targeting the Lp-PLA2 enzyme, which is involved in the build-up of plaque in blood vessels.
Before the disappointing results came in Reuters analysts said darapladib could reach $10 billion in sales, as it sits within a lucrative market that saw Pfizer’s landmark statin Lipitor (atorvastatin) enjoy annual sales of over $12 billion at its peak.
This is the second major Phase III setback the firm has encountered in just over two months. In September its melanoma vaccine MAGE-A3 failed in late-stage trials, representing a huge disappointment for the company.
The British pharma giant acquired rights to darapladib last year as part of its $3 billion buy-out of US biotech firm Human Genome Sciences. The deal was considered risky at the time due to inconclusive data on the compound, and these results will further validate those concerns.
Vallance confirmed that a second Phase III trial of darapladib is ongoing, with results expected in March 2014. The sister study is investigating whether the pill can reduce the risk of further acute coronary events among patients who have already had a stroke or heart attack.
According to NHS figures, coronary heart disease is ‘the UK’s biggest killer’, accounting for over 80,000 deaths every year.
World Health Organization data indicate that more people have died globally as a result of the condition since 1990 than any other disease.
Hugh McCafferty
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