Please login to the form below

Not currently logged in
Email:
Password:

GSK hit as darapladib flunks phase III test

Heart disease drug disappoints in late-stage trial

GlaxoSmithKline (GSK) House 

GlaxoSmithKline's highly anticipated new coronary heart disease (CHD) drug candidate darapladib has disappointed in a phase III trial.

Top-line results from the STABILITY study revealed that the Lp-PLA2 inhibitor was unable to achieve a significant reduction in major cardiovascular events, including heart attack, stroke and cardiovascular death, compared to placebo.

Darapladib is designed to prevent the rupture of atherosclerotic plaques, a process which leads to heart attacks and strokes in patients with CHD, and was one of the compounds that prompted GSK's $3bn acquisition of Human Genome Sciences (HGS) in 2012.

If effective, the drug would be a candidate for the millions of people worldwide who do not get a strong enough response from statin drugs, which could make darapladib a blockbuster with sales of several billion dollars a year.

GSK's head of pharmaceutical R&D Patrick Vallance noted there were some trends towards a benefit in secondary measures in STABILITY and said further analysis is ongoing.

"Given the level of patient need in this area, we continue to investigate the role of Lp-PLA2 inhibition in coronary heart disease and other disease," he said, adding the company will continue to examine the data and wait for the results of a second phase III trial of darapladib in acute coronary syndrome (ACS).

Analysts were not overwhelmingly hopeful of a positive outcome, however, given that darapladib failed a phase II study looking at its ability to resolve plaques while another drug with a similar mode of action - Anthera Pharmaceuticals' varespladib - was found to be infective in a phase III ACS trial last year.

Panmure Gordon downgraded GSK from 'Buy' to 'Hold' on the news yesterday, with analyst Savvas Neophytou saying that even if the ACS trial (SOLID-TIMI 52) is successful "we believe it will be difficult to gain market registration on one trial alone".

This is the second big disappointment in GSK's late-stage pipeline this year after its melanoma immunotherapy MAGE-A3 missed its targets.

Article by
Phil Taylor

13th November 2013

From: Research

Share

Tags

Featured jobs

Subscribe to our email news alerts

PMHub

Add my company
Sciterion

Sciterion is an award winning specialist healthcare communications consultancy within the Havas Health network of companies. We exist to make...

Latest intelligence

Combined immunotherapies – potential and pitfalls
‘Combining therapeutic compounds is the first logical step towards better results, namely higher rates of patients responding to treatment, with deeper and more sustained responses’...
Report: Achieving launch excellence in the challenging healthcare markets of today
Our in-depth report is based on original data and expert interviews, which coupled with our own experience, ensures we give you the best recommendations for achieving launch success in challenging...
What is blockchain and why should i care - Richard Springham
Four Health - Emerging Technologies The power of blockchain lies in the fact it can prove that a unique event occurred at a certain time with out the need to...

Infographics