AstraZeneca’s Brilinta has missed its targets in a Phase III trial assessing the blood thinner in patients with acute ischaemic stroke or transient ischaemic attack.
The drug failed on the primary efficacy endpoint of increasing the time to first occurrence of stroke (ischaemic or haemorrhagic), myocardial infarction or death compared to aspirin.
Fewer events were observed on Brilinta/Brilique (ticagrelor) versus aspirin in the overall SOCRATES trial population, but the trend did not reach statistical significance, AZ noted.
The drug giant’s chief medical officer Sean Bohen stressed that the trial enrolled a patient population that differs from the currently-approved indications for Brilinta/Brilique, and noted that a full analysis of the data, including on subgroups, will be presented at a forthcoming stroke congress.
Brilinta/Brilique is a direct-acting P2Y12 receptor antagonist that works by inhibiting platelet activation, which has been shown to reduce the rate of thrombotic cardiovascular events, such as heart attack or CV death, in patients with Acute Coronary Syndrome (ACS).
The drug is approved to reduce the rate of thrombotic CV events in patients with ACS, non–ST-elevation myocardial infarction (NSTEMI), or ST-elevation myocardial infarction (STEMI), as well as for the treatment of patients who have suffered a heart attack at least one year prior and are at high risk of developing a further atherothrombotic event.