Glaxo Presents Darapladib Data - Analyst Blog

GlaxoSmithKline GSK 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.

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 include Alkermes ALKS, Alexion Pharmaceuticals, Inc. ALXN and Gilead Sciences Inc. GILD, all of which carry a Zacks Rank #1 (Strong Buy).