CSL Behring presents positive results from CSL112 Phase IIb trial

CSL112 is being developed to reduce the high incidence of early recurrent cardiovascular events.

The AEGIS-I study met its co-primary safety endpoints, showing that CSL112 does not cause significant changes in liver or kidney function and demonstrating that it is well-tolerated when administered in the post myocardial infarction (MI) (or heart attack) 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 with 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, CSL112 may rapidly stabilize additional lesions at risk of rupture thereby reducing the high rate of recurrent events following a heart attack.

"We are highly encouraged by the impressive results of this clinical study demonstrating that CSL112 significantly increases cholesterol efflux capacity in patients who have suffered a heart attack, with no significant changes to liver or kidney function," said Larry Deckelbaum, Global Clinical Therapeutic Area Head, Cardiovascular at CSL Behring. "The AEGIS-I results support continued planning for Phase III to determine whether increasing cholesterol efflux capacity with CSL112 translates into improved cardiovascular outcomes."