Australia-based biotherapeutics company CSL is set to begin a Phase lll trial of CSL112 to help reduce early recurrent cardiovascular events in heart attack survivors.
The trial will be known as ApoA-I Event reducinG in Ischemic Syndromes II (AEGIS-II) and is subject to final agreement with the US Food and Drug Administration (FDA).
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More than 17,000 patients from around 1,000 sites across the world will be involved in the multicentre, double-blind, randomised, placebo-controlled, parallel-group study.
AEGIS-II will assess the efficacy and safety of CSL112 to reduce the risk of cardiovascular death, myocardial infarction, and stroke in acute coronary syndrome (ACS) in patients receiving evidence-based medical therapy, diagnosed with either ST-elevation myocardial infarction (STEMI) or non-ST-elevation myocardial infarction (NSTEMI).
Harvard Medical School Medicine professor Michael Gibson will serve as the co-lead investigator of AEGIS-II, which is anticipated to take four years to complete.
Patient enrolment for the trial is expected to begin by early next year.
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By GlobalDataGibson said: “Despite recent advances in cardiovascular care, we still have an unacceptable rate of early recurrent cardiovascular events occurring in high-risk patients following an acute MI.
“We are optimistic that CSL112 will offer a novel, rapid approach to reduce these events during the 90-day period when heart attack survivors are most vulnerable.”
According to the World Health Organisation’s Cardiovascular diseases (CVDs) – Fact Sheet 2017, CVD is the main cause of death across the world.
Around 54,000 people are also estimated to be hospitalised as a result of a heart attack in Australia every year.
