CSL Behring initiates Phase III AEGIS-II trial for post MI reduction of CV events.

CSL Behring 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 CSL 112 for the reduction of early recurrent cardiovascular events following an acute myocardial infarction (MI).

CSL 112 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.AEGIS-II is a Phase III, multicenter, double-blind, randomized, placebo-controlled, parallel-group study designed to evaluate the efficacy and safety of CSL 112 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.