Top-line results from a Phase III study showed that AstraZeneca's Brilinta (ticagrelor), taken with aspirin, significantly reduced the risk of the primary composite endpoint of stroke and death versus aspirin alone in patients who recently suffered an acute ischaemic stroke or transient ischaemic attack, the company reported Monday. Mene Pangalos, executive vice president of biopharmaceuticals R&D, said "we look forward to sharing the detailed results with health authorities."
The THALES trial enrolled over 11,000 patients who had a minor acute ischaemic stroke or high-risk transient ischaemic attack in the 24 hours prior to treatment initiation. Subjects were randomised within 24 hours of onset of acute ischaemic stroke or high-risk transient ischaemic attack symptoms to receive a loading dose of Brilinta on day one, followed by twice-daily treatment on days two to 30, or matching placebo. All patients also received aspirin for 30 days. The primary efficacy outcome was the time to the composite endpoint of stroke and death at 30 days.
In regards to safety, AstraZeneca said preliminary findings in the trial were consistent with the known profile of the P2Y platelet inhibitor, "with an increased bleeding rate in the treatment arm." Lead investigator Clay Johnston noted that "while an expected increase in bleeding was observed, the findings from THALES showed that Brilinta, in combination with aspirin, reduced the risk of potentially devastating events in this crucial time." The company will present full trial results at a forthcoming medical meeting.
Brilinta, which generated sales of $416 million in the third quarter, is approved in more than 110 countries for the treatment of acute coronary syndrome and in more than 70 countries for the secondary prevention of cardiovascular events among high-risk patients who have experienced a heart attack.
Separately on Monday, AstraZeneca agreed to divest a portfolio of established hypertension drugs to Atnahs Pharma for an upfront payment of $350 million and also regained rights to the experimental IL-23 inhibitor brazikumab from Allergan.
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