CSL Fails Its Phase 3 Aegis-Ii Trial for CSL112

CSL’s phase 3 AEGIS-II trial of CSL112 fails to meet its primary efficacy endpoint of MACE reduction at 90 days

Global biotechnology leader CSL announced top-line results from the phase 3 AEGIS-II trial evaluating the efficacy and safety of CSL112 (apolipoprotein A-I [human]) compared to placebo in reducing the risk of major adverse cardiovascular events (MACE) in patients following an acute myocardial infarction (AMI). 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.

Investigator’s word

We look forward to sharing our scientific learnings regarding cholesterol efflux and recurrent cardiovascular events, said C. Michael Gibson, M.S., M.D., Baim Institute for Clinical Research, Harvard Medical School. We will continue to analyze the findings and share the full results in the coming months.

Further analysis of AEGIS-II is ongoing and primary results will be presented at the American College of Cardiology Scientific Sessions, held April 6, 2024, and published in a peer-reviewed journal.

Response from CSL

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 programme, said Dr. Bill Mezzanotte, executive vice president, head of R&D, for CSL. AEGIS-II is the most ambitious study in our company's history and we are proud of the quality of the study we delivered and the enhanced capabilities we developed to do so. We plan to apply these capabilities as well as our plasma protein platform to future unmet medical need in cardiovascular and metabolic conditions as well as those in our other strategic therapeutic areas.

What Is Aegis-Ii Trial? 

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.

Lead Molecule

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 Company

CSL 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.

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