CSL Behring, a global biotherapeutics leader, today announced the initiation of the AEGIS-II (ApoA-I Event reducinG in Ischemic Syndromes II) clinical trial and the first patient enrollment. The clinical trial will evaluate the efficacy and safety of CSL112 for the reduction of early recurrent cardiovascular events following an acute myocardial infarction (MI). CSL112 is a novel apolipoprotein A-I infusion therapy that has been shown to have an immediate and significant impact on the ability to remove cholesterol from arteries. The AEGIS-II trial will enroll more than 17,000 patients from approximately 1,000 medical centers around the world.
Cardiovascular disease is the leading cause of death globally, with an estimated 800,000 acute MIs occurring each year in the US alone. Patients who survive an acute MI are at high risk of experiencing early recurrent cardiovascular events. The majority of these events occur in the weeks and months following the initial event and are associated with a high rate of morbidity and mortality.
"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," said C. Michael Gibson, M.D., M.S., Professor of Medicine at Harvard Medical School and Chairman of the AEGIS-II study. "CSL112 is an exciting new approach in cardiovascular medicine that may help protect our patients when they are most vulnerable."
CSL112 is a novel formulation of apoA-I derived from human plasma. Research has shown that CSL112 can produce an immediate and significant enhancement in cholesterol efflux capacity, a measurement of the body's ability to remove excess cholesterol from cells. CSL112 is the only apoA-I therapy to proceed to a large-scale Phase 3 cardiovascular clinical trial.
"The enrollment of the first patient into AEGIS-II is an important milestone in the AEGIS clinical program and the development of CSL112 as a potential innovative approach for preventing early recurrent cardiovascular events in heart attack survivors," said Andrew Cuthbertson, Chief Scientific Officer and R&D Director for CSL Limited. "CSL's research with CSL112 reflects our ongoing commitment to improve the lives of patients through the discovery and development of novel therapies."
MORE ON AEGIS-II
AEGIS-II is a Phase 3, multicenter, double-blind, randomized, placebo-controlled, parallel-group study designed to evaluate the efficacy and safety of CSL112 on reducing the risk of major adverse cardiovascular events (MACE), defined as heart attack, stroke or cardiovascular death, in patients with acute coronary syndrome (ACS). This includes patients with either ST-elevation myocardial infarction (STEMI) or non-ST-elevation myocardial infarction (NSTEMI), and those managed with percutaneous coronary intervention (PCI) or medically managed. Patients with unstable angina will be excluded from the study. The study will enroll approximately 17,400 patients from 1,000 sites in 40 countries.
Patients will be randomized in a 1:1 ratio and will receive either CSL112 6g or placebo, administered through IV infusion once weekly for four consecutive weeks. The primary endpoint is the first occurrence of MACE from the time of randomization through 90 days. Patients will continue to be followed for a total of 365 days.
AEGIS-II is being 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 and is expected to be completed within approximately four years.
ABOUT THE AEGIS CLINICAL STUDY PROGRAM
Prior to AEGIS-II, results from the Phase 2b AEGIS-I study were presented at the American Heart Association Scientific Sessions 2016 and published in Circulation. A multicenter, randomized, double-blind, placebo-controlled, dose-ranging study, AEGIS-I met its primary safety endpoints, showing CSL112 did not cause significant changes in liver or kidney function and was well tolerated when administered to patients who experienced a heart attack. The study also co...
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