CSL Unveils Phase 3 AEGIS-II Trial Results on CSL112 (Apolipoprotein A-I)

Global biotech leader CSL has released significant findings from its Phase 3 AEGIS-II study. This clinical trial assessed the effectiveness and safety of CSL112, a human apolipoprotein A-I, in reducing major cardiovascular events (MACE) in patients who have experienced an acute myocardial infarction (AMI). Conducted over 90 days, the study involved more than 18,200 participants across 49 countries, who were administered CSL112 or a placebo.

Unfortunately, the trial did not achieve its primary goal of reducing MACE. Consequently, CSL does not plan to pursue regulatory approvals in the near term. Importantly, no major safety or tolerability concerns arose with CSL112 during the study period.

Dr. C. Michael Gibson from the Baim Institute for Clinical Research at Harvard Medical School commented on the findings, emphasizing the team's commitment to further analyze and disseminate the results. Detailed data from the trial will be presented at the American College of Cardiology Scientific Sessions in April 2024 and subsequently published in a peer-reviewed journal.

Executive Vice President and Head of Research and Development at CSL, Dr. Bill Mezzanotte, expressed gratitude to all participants and acknowledged the extensive work required to fully understand the trial data. He highlighted the significance of the AEGIS-II study as the most ambitious in CSL's history. Despite the primary endpoint not being met, he stressed the importance of the advancements made and the robust study design.

Dr. Mezzanotte also outlined CSL's plans to leverage the insights and capabilities gained from the AEGIS-II trial to address unmet medical needs in cardiovascular and metabolic conditions, along with other strategic therapeutic areas.

CSL112, an investigational drug, aims to enhance cholesterol efflux. It was developed from human plasma-derived apoA-I, which is the key functional component of high-density lipoproteins (HDL). The trial's design was a multicenter, double-blind, randomized, placebo-controlled study, ensuring rigorous assessment of CSL112’s potential.

CSL is a global biotechnology company with a rich history dating back to 1916. The company focuses on developing and delivering lifesaving medicines and is involved in treating haemophilia, immune deficiencies, and providing influenza vaccines. CSL operates globally, reaching over 100 countries, and employs around 32,000 people. Its businesses include CSL Behring, CSL Seqirus, and CSL Vifor, each contributing to its mission of improving patient outcomes through innovative therapies.