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LONDON (Alliance News) - GlaxoSmithKline PLC said Monday that its Phase III STABILITY study for darapladib in the treatment of patients with chronic coronary heart disease failed to meet its primary endpoint, although it said that the effects of the drug on the reduction of coronary events was of potential interest.
The study's primary endpoint was time to first occurrence of any major adverse cardiovascular event, including cardiovascular death, myocardial infarction and stroke. It showed there was no difference to this endpoint between patients receiving darapladib or a placebo.
During a 3.7 years media follow up, major adverse cardiovascular events occurred in 9.7% of patients receiving the drug and in 10.4% of patients receiving the placebo.
The secondary endpoint address major coronary events. Major coronary events occurred in 9.3% of patients taking the drug compared to 10.3% in the placebo group.
"In the STABILITY study, the lack of effect on stroke was disappointing but not unexpected given the emerging epidemiology data," said the co-chair of the study, Harvey White, director of the Coronary Care Unit at the Auckland City Hospital in New Zealand. "While the study didn't meet its primary endpoint, the affects of darapladib on the reduction of coronary events are of potential interest. These findings take us a step further towards defining which patients may benefit from treatment with darapladib."
The company is waiting for results of its second Phase III study using the drug, SOLID-TIMI 52, to have a better understand of the STABILITY study.
Darapladib is not approved for use anywhere in the world.
Shares in Glaxo were trading up 0.2% at 1,620.56 pence Monday morning.
By Hana Stewart-Smith; hanassmith@alliancenews.com; @HanaSSAllNews
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