CSL Behring has started the ‘ApoA-I Event reducinG in Ischemic Syndromes II’ (AEGIS-II) Phase III clinical trial of CSL112 to reduce early recurrent cardiovascular events after an acute myocardial infarction (MI).
The study will evaluate the efficacy and safety of CSL112 in reducing the risk of major adverse cardiovascular events (MACE) in patients with acute coronary syndrome (ACS).
MACE is defined as heart attack, stroke or cardiovascular death.
The company has completed the enrolment of its first patient for the AEGIS-II trial, which will include more than 17,000 patients from about 1,000 medical centres in 40 countries.
The novel apolipoprotein A-I infusion therapy CSL112 has been shown to have an immediate impact on the ability to remove cholesterol from arteries.
AEGIS-II study chairman Michael Gibson said: “The AEGIS-II study will tell us if a rapid enhancement of the body’s ability to remove cholesterol from the arteries can reduce the rate of early recurrent CV events in heart attack survivors.
“CSL112 is an exciting new approach in cardiovascular medicine that may help protect our patients when they are most vulnerable.”
Research showed that CSL112, a novel formulation of apoA-I derived from human plasma, can produce an immediate and significant enhancement in cholesterol efflux capacity.
The AEGIS-II trial will exclude patients with unstable angina and will see a randomisation of participants in a 1:1 ratio. They will receive either CSL112 6g or placebo, administered through IV infusion once a week for four consecutive weeks.
The study’s primary objective is the first occurrence of MACE from the time of randomisation through 90 days.
Set to be conducted under the academic leadership of the PERFUSE Group at Beth Israel Deaconess Medical Center, the Duke Clinical Research Institute, and the Stanford Cardiovascular Institute, the AEGIS-II trial is expected to be completed within four years.