The study did not meet its primary efficacy endpoint of MACE reduction at 90 days. As a result, there are no plans for a near-term regulatory filing. There were no major safety or tolerability concerns with CSL112.
'We look forward to sharing our scientific learnings regarding cholesterol efflux and recurrent cardiovascular events,' said
Further analysis of AEGIS-II is ongoing and primary results will be presented at the
'Substantial work remains to fully analyze and understand the complete data and then to determine any development path ahead for this asset. We thank all the patients, families, caregivers, and investigators for their support and participation in the AEGIS program,' said Dr.
About AEGIS-II
The AEGIS-II trial is a Phase 3 multicenter, double-blind, randomized, placebo-controlled, parallel-group study which evaluated the efficacy and safety of CSL112 in the reduction of recurrent cardiovascular events in the 90-day high-risk period that follows a heart attack. The study enrolled over 18,200 patients from over 850 sites in 49 countries. Participants were randomized to receive 4 weekly doses of CSL112 or placebo initiated within 5 days of first medical contact.
About CSL112
CSL112, Apolipoprotein A-I (Human), is an investigational cholesterol efflux enhancer, developed using a novel formulation of human plasma-derived apoA-I, the primary functional component of high-density lipoproteins (HDL).
About CSL
CSL (ASX:CSL; USOTC:CSLLY) is a global biotechnology company with a dynamic portfolio of lifesaving medicines, including those that treat haemophilia and immune deficiencies, vaccines to prevent influenza, and therapies in iron deficiency and nephrology. Since our start in 1916, we have been driven by our promise to save lives using the latest technologies. Today, CSL - including our three businesses:
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Tel: +1 610 906 4564
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Tel: +1 610 291 5388
Email: Jimmy.Baker@csl.com.au
Tel: +61 450 909 211
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