WASHINGTON, March 30 An experimental heart drug
being developed by GlaxoSmithKline, which failed the
main goal of a Phase III study of patients with chronic but
well-treated heart disease, showed signs of potential benefit,
the trial's co-leader said Sunday.
The results presented at the American College of Cardiology
scientific meeting in Washington provided a glimmer of hope that
the medicine may have value.
"I'm convinced there is a signal here of efficacy," said Dr.
Harvey White, co-chair of the Glaxo-sponsored international
The real test of the drug, darapladib, is likely to come
from a second, late stage study in far less stable patients who
received the medicine within 30 days of a heart attack.
A positive result in that study could put the drug back on
track, after it was largely discounted by analysts and investors
following the first Phase III failure.
The stakes are high for the British drugmaker as gaining
full control of darapladib was one of the reasons behind its
$3.6 billion acquisition of Human Genome Sciences in 2012.
Human Genome had rejected an earlier $2.6 billion offer, on
the grounds that Glaxo was underestimating the blockbuster sales
potential of darapladib.
Glaxo had previously said darapladib did no better than a
placebo in decreasing the risk of a combination of
cardiovascular death, heart attack and stroke in the trial
That trial involved 15,828 patients followed for a median of
For those taking the Glaxo pill, 9.7 percent had one of the
major adverse events compared with 10.4 percent for placebo,
which was not a statistically significant difference.
A lack of any impact on stroke prevention appears to have
contributed to the failure of the study, researchers surmised.
In addition, the effect of the Glaxo drug may have been
muted by the high level of care the patients were receiving.
Almost all were taking statins and aspirin and nearly 80
percent were on blood pressure drugs - all known to decrease the
risk of heart attacks, strokes and death.
The drug's impact on a pair of composite secondary goals of
the study was deemed "nominally significant" by researchers,
meaning they saw the potential of a clinically meaningful effect
despite falling short of statistical significance.
(Reporting by Bill Berkrot; Editing by Sophie Hares)