CSL commences phase IIb heart attack trial

CSL (ASX:CSL) has commenced a phase IIb clinical trial of CSL112 as a preventative treatment for recurrent cardiovascular events associated with cholesterol.

The AEGIS-I trial, which commenced last week, will involve 1200 patients who have experienced a heart attack. The randomised, placebo-controlled, dose-ranging trial will investigate the safety and tolerability of multiple dose administration of the drug.

Secondary outcome measures will include time-to-first-occurrence of a major adverse cardiovascular event, defined as cardiovascular death, myocardial infarction (MI), ischemic stroke and hospitalisation for unstable angina.

CSL112 is designed to purge cholesterol from the arteries and stabilise lesions at risk of rupture. CSL this week presented two research studies into the mechanisms of action behind CSL112, a formulation of apolipoprotein A-1.

Data from studies in 93 healthy subjects and 44 with stable atheorsclerotic disease show that CSL112 caused elevation in cholesterol efflux independent of baseline efflux activity.

The research shows that CSL112 is rapidly remodelled to form pre-β1 HDL, which is associated with superior cholesterol efflux capacity.

“Both studies advance our understanding of the role of CSL112 in rapidly inducing cholesterol efflux, the first step in reverse cholesterol transport, and its potential to rapidly reduce early recurrent cardiovascular events in the post MI setting,” said Samuel Wright, CSL Behring global strategic director of cardiovascular therapeutics.

Patients are at highest risk of experiencing a recurrent cardiovascular event in the first 30 days following the initial heart attack, and preventative treatment options are limited.

CSL (ASX:CSL) shares were trading 0.09% lower at $78.27 as of around 1 pm on Thursday.