GlaxoSmithKline (GSK) announced disappointing top-line data from a phase III study on its chronic coronary heart disease (CHD) candidate, darapladib. Investors reacted negatively to the news with the stock price falling approximately 1.6%.
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, which enrolled more than 15,000 patients, 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. Full data from the STABILITY study will be presented in 2014 at a scientific meeting.
Meanwhile, the second phase III study, SOLID-TIMI 52 (n >13,000), evaluating darapladib in patients suffering from acute coronary syndrome is expected to be completed in 2014.
Darapladib, which became a part of Glaxo’s portfolio through the Aug 2012 acquisition of Human Genome, was one of the most interesting late-stage candidates in Glaxo’s pipeline. With the candidate failing in a big study, expectations for success in the second study, SOLID-TIMI 52, will be low.
Other Setbacks
Over the last few months Glaxo has suffered quite a few late-stage pipeline setbacks. In Sep 2013, Glaxo had announced negative data from a phase III study on drisapersen. Glaxo is developing drisapersen in collaboration with Prosensa (RNA) for the treatment of patients suffering from Duchenne muscular dystrophy (DMD).
Glaxo’s MAGE-A3 cancer immunotherapeutic also failed to meet its first co-primary endpoint in the phase III DERMA study.
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 the provided a much needed boost to Glaxo's revenues.
Glaxo carries a Zacks Rank #3 (Hold). Right now, Bayer (BAYRY) and Johnson & Johnson (JNJ) look attractive. Both carry a Zacks Rank #2 (Buy).
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