NASDAQ : Brilinta met primary endpoint in Phase III THALES trial in stroke

Brilinta met primary endpoint in Phase III THALES trial in stroke

27 January 2020 07:00 GMT

Brilinta met primary endpoint in Phase III THALES trial in stroke

Brilinta reduced the risk of the composite of stroke and death
after an acute ischaemic stroke or transient ischaemic attack

High-level results from the Phase III THALES trial showed
AstraZeneca's Brilinta (ticagrelor) 90mg used twice daily and taken with aspirin
for 30 days, reached a statistically significant and clinically meaningful
reduction in the risk of the primary composite endpoint of stroke and death,
compared to aspirin alone.

THALES was conducted in over 11,000 patients who had a minor acute ischaemic
stroke or high-risk transient ischaemic attack (TIA) in the 24 hours prior to
treatment initiation. The preliminary safety findings in the THALES trial were
consistent with the known profile of Brilinta, with an increased bleeding rate
in the treatment arm.

Mene Pangalos, Executive Vice President, BioPharmaceuticals R&D, said: 'Results
of the Phase III THALES trial showed Brilinta, in combination with aspirin,
improved outcomes in patients who had experienced a minor acute ischaemic stroke
or high-risk transient ischaemic attack. We look forward to sharing the detailed
results with health authorities.'

Dr. Clay Johnston, lead investigator for the THALES trial and Dean of the Dell
Medical School at The University of Texas at Austin, US, said: 'The risk of
having a subsequent stroke is highest in the first few days and weeks after a
minor acute ischaemic stroke or high-risk transient ischaemic attack. 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 full THALES trial results will be presented at a forthcoming medical
meeting.

Brilinta is approved in more than 110 countries for the treatment of acute
coronary syndrome (ACS) and in more than 70 countries for the secondary
prevention of cardiovascular (CV) events among high-risk patients who have
experienced a heart attack.

Stroke
Stroke is the second leading cause of death worldwide, with 6.2 million stroke
-related deaths in 2017, from which 2.7 million were due to ischaemic
stroke.[1] Patients who experience an acute ischaemic stroke or TIA are at high
risk of developing subsequent ischaemic events, with particularly high risk
within 30 days after the initial event and the highest risk period being the
first 24 hours after the initial event.[2]

THALES
THALES is an AstraZeneca-sponsored, randomised, placebo-controlled, double
-blinded, international, multicentre, event-driven trial involving more than
11,000 patients to test the hypothesis whether Brilinta and aspirin is superior
to aspirin alone in preventing the composite of stroke and death in patients
with minor acute ischaemic stroke or high-risk TIA. Patients were randomised
within 24 hours of onset of acute ischaemic stroke or high-risk TIA symptoms and
followed-up for 30 days of treatment. Trial treatments were Brilinta 180mg
loading dose on day 1 as soon as possible after randomisation, followed by 90mg
twice daily on days 2-30, or matching placebo. All patients received open-label
aspirin 300-325mg on day 1, followed by 75-100mg once daily on days 2-30. The
primary efficacy outcome was the time to the composite endpoint of stroke and
death at 30 days. The primary safety outcome is time to first severe bleeding
event according to the Global Utilization of Streptokinase and Tissue
Plasminogen Activator for Occluded Coronary Arteries (GUSTO) definition.
Patients were followed for an additional 30 days on standard of care.

Brilinta
Brilinta is an oral, reversible, direct-acting P2Y12 receptor antagonist that
works by inhibiting platelet activation. Brilinta, together with aspirin, has
been shown to significantly reduce the risk of major adverse CV events
(myocardial infarction, stroke or CV death), in patients with ACS or a history
of myocardial infarction (MI).

Brilinta, co-administered with aspirin, is indicated for the prevention of
atherothrombotic events in adult patients with ACS, or for patients with a
history of MI and a high risk of developing an atherothrombotic event.

AstraZeneca in CVRM
Cardiovascular, Renal and Metabolism (CVRM) together forms one of AstraZeneca's
three therapy areas and is a key growth driver for the Company. By following the
science to understand more clearly the underlying links between the heart,
kidneys and pancreas, AstraZeneca is investing in a portfolio of medicines to
protect organs and improve outcomes by slowing disease progression, reducing
risks and tackling comorbidities. The Company's ambition is to modify or halt
the natural course of CVRM diseases and potentially regenerate organs and
restore function, by continuing to deliver transformative science that improves
treatment practices and cardiovascular health for millions of patients
worldwide.

AstraZeneca
AstraZeneca (LSE/STO/NYSE: AZN) is a global, science-led biopharmaceutical
company that focuses on the discovery, development and commercialisation of
prescription medicines, primarily for the treatment of diseases in three therapy
areas - Oncology, Cardiovascular, Renal and Metabolism, and Respiratory.
AstraZeneca operates in over 100 countries and its innovative medicines are used
by millions of patients worldwide. Please
visit astrazeneca.com (http://www.astrazeneca.com/) and follow the Company on
Twitter @AstraZeneca (https://twitter.com/AstraZeneca).

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References
1. Roth GA et al. Global, regional, and national age-sex-specific mortality for
282 causes of death in 195 countries and territories, 1980-2017: A systematic
analysis for the Global Burden of Disease Study 2017. The Lancet 2018;
392(10159):1736-88.
2. Khanevski AN, et al. Thirty-day recurrence after ischemic stroke or TIA.
Brain Behav 2018; 8(10):e01108.

Adrian Kemp
Company Secretary
AstraZeneca PLC

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