Therapy Areas: Cardiovascular
CSL reveals top-line outcome from Phase three AEGIS-II trial of CSL112
12 February 2024 -

CSL (ASX:CSL; USOTC:CSLLY), a global biotechnology company, announced on Sunday the top-line outcome from its Phase three AEGIS-II trial assessing the efficacy and safety of CSL112 (apolipoprotein A-I [human]) compared to placebo in decreasing the risk of major adverse cardiovascular events (MACE) in subjects subsequent to an acute myocardial infarction (AMI).

The study has not met its primary efficacy endpoint of MACE decrease at 90 days. Due to this, there are no plans for a near-term regulatory filing. The study did not identify any major safety or tolerability concerns with the product. Further evaluation of AEGIS-II is ongoing and primary outcome will be showcased at the American College of Cardiology Scientific Sessions, scheduled at 6 April 2024, and published in a peer-reviewed journal.

The AEGIS-II trial enrolled more than 18,200 subjects from more than 850 sites in 49 countries. Subjects were randomised to receive four weekly doses of the product or placebo started within five days of first medical contact.