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Novel apolipoprotein A-I formulation studied in AEGIS-I

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A new phase 2b trial will assess a novel apolipoprotein A-I formulation and its effect on markers of reverse cholesterol transport and the stabilization of atherosclerotic lesions, according to a press release.

The randomized, placebo-controlled, dose-ranging AEGIS-I study is designed to evaluate the safety and tolerability of multiple weekly infusions of CSL112 (CSL Limited) in a cohort of 1,200 patients with acute MI.

CSL112 is purified from human plasma and reconstituted to form HDL particles for IV infusion. Previous research has demonstrated that CSL112 infusion rapidly elevated markers of reverse cholesterol transport, according to the release.

Secondary outcomes of the AEGIS-I study will include time to first major adverse CV event, including CV death, MI, ischemic stroke or hospitalization due to unstable angina.

The phase 2b trial will be the first to assess the CSL112 in patients with acute MI, according to the release.

C. Michael Gibson

“Patients are at highest risk of experiencing a recurrent CV event in the first 30 days following the index event, and physicians have few treatment options to address this risk,” study chairman C. Michael Gibson, MS, MD, professor of medicine at Harvard Medical School, stated in the release. “CSL112 holds the potential to work quickly to reduce early recurrent events, thereby addressing a substantial unmet medical need.”