Csl112 Restores Cholesterol Efflux In Patients Immediately After Acute Myocardial Infarction

Introduction: CSL112 is human apolipoprotein A-I (apoA-I), currently in development for reduction of cardiovascular (CV) risk in the subacute period after acute myocardial infarction (AMI). Infusion of CSL112 elevates serum cholesterol efflux capacity (CEC) which is postulated to reduce plaque size and instability. AMI is followed by acute phase response and depression in reverse cholesterol transport (RCT). Hypothesis: The aim of this analysis was to compare the 1st CSL112 dose (during acute phase) vs. 4th dose (after resolution) for apoA-I and CEC after MI. Methods: AEGIS-I was a randomized, double blind, placebo controlled, dose ranging phase 2b trial assessing the safety of 4 weekly 2 h infusions of CSL112 in AMI subjects. We assessed biomarkers of cholesterol movement following CSL112 infusions in a substudy of 63 subjects randomly assigned 3:3:2 to 2 g (n=24) or 6 g (n=21) CSL112 or placebo (n=18). Results: Each 6 g CSL112 dose caused strong (u003e2-fold) elevation of apoA-I, and baseline-corrected valu...