Results of AEGIS-I study of CSL 112 to reduce the high incidence of early recurrent cardiovascular events post heart attack.- CSL Behring

A novel apolipoprotein A-I (apoA-I) infusion therapy CSL 112 from CSL Behring, is being developed to reduce the high incidence of early recurrent cardiovascular events that occur in the weeks to months following a heart attack, most commonly due to additional rupture of vulnerable atherosclerotic plaque, which is an accumulation of fatty material on the innermost layer of the artery wall and which can obstruct blood flow.

The AEGIS-I study met its co-primary safety endpoints, showing that CSL 112 does not cause significant changes in liver or kidney function and demonstrating that it is well-tolerated when administered in the acute myocardial infarction (MI) setting. The study also provided confirmation of CSL112�s unique mechanism of action, cholesterol efflux enhancement, as demonstrated by an immediate, up to four-fold increase in cholesterol efflux capacity, compared to baseline. It is believed that by producing an immediate and profound enhancement of cholesterol efflux capacity, which is the removal of cholesterol from the plaque in the arteries, CSL 112 may rapidly stabilize additional lesions at risk of rupture thereby reducing the high rate of recurrent events following a heart attack. Results from AEGIS-I were presented at the American Heart Association Scientific Sessions in New Orleans, LA and published online in Circulation.

Comment:The main goal of this trial was to assess changes in drug-induced liver injury and renal status in the 29 days after the first infusion. On these measures, which were the co-primary endpoints of the study, incidence rates for both cohorts of CSL 112 patients were comparable to the placebo arm.That resulted in the trial meeting its primary endpoint. Less conclusive was CSL 112�s performance against a secondary efficacy endpoint. CSL tracked the time-to-first occurrence of a major adverse cardiovascular event, such as a heart attack or stroke. The endpoint could have suggested CSL 112 protects patients in the dangerous 30-day period following a heart attack, but CSL found �the risk ... among the groups was similar.� CSL is now planning an adequately-powered Phase III trial to show CSL 112 reduces the risk of major cardiovascular adverse events.