) presented data from a phase III study on its chronic coronary
heart disease (CHD) candidate, darapladib at the American College
of Cardiology. The data was also published in the New England
Journal of Medicine.
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The randomized, placebo-controlled, double-blind, parallel group,
multi-centre, event-driven STABILITY study (STabilisation of
Atherosclerotic plaque By Initiation of darapLadIb TherapY) is
the first of two phase III studies on darapladib. The STABILITY
study (n = 15,828) assessed the use of darapladib in combination
with current standard of care (statin, aspirin and blood pressure
treatments) versus placebo plus standard of care.
The study failed to meet its primary endpoint. The primary
endpoint was time to first occurrence of any major adverse
cardiovascular event (MACE) including cardiovascular death,
nonfatal myocardial infarction and nonfatal stroke.
In the time to first occurrence of MACE, no difference was found
between both arms of the study. During median follow-up period
(3.7 years) MACE occurred in 9.7% of patients receiving
darapladib plus standard of care versus 10.4% receiving standard
of care alone.
Secondary endpoints of the study included major coronary events
(MCE), total coronary events and all-cause mortality. MCE and
total coronary events occurred in 9.3% and 14.9%, respectively,
in the darapladib plus standard of care arm versus 10.3% and
16.1%, in the other arm of the study. No difference in all-cause
mortality, which occurred in 7.3% of patients, was observed
between both arms.
We note that Glaxo had announced disappointing top-line data from
the STABILITY study in Nov 2013.
Meanwhile, the second phase III study, SOLID-TIMI 52 (n
>13,000), evaluating darapladib in patients suffering from
acute coronary syndrome is ongoing. Data from the study is
expected in the second quarter of 2014.
With the candidate failing in a big study, expectations for
success in the second study, SOLID-TIMI 52, are low. We believe
that positive data from the STABILITY study would have supported
regulatory filings and increased Glaxo's chances of gaining
approval for darapladib. This would have provided a much needed
boost to Glaxo's revenues.
Glaxo carries a Zacks Rank #4 (Sell). Some better-ranked stocks
Alexion Pharmaceuticals, Inc.
Gilead Sciences Inc.
), all of which carry a Zacks Rank #1 (Strong Buy).