ABIONYX Pharma Confirms Phase 3 AEGIS-II Trial Outcomes for CSL112

ABIONYX Pharma, a cutting-edge biotechnology firm listed under the stock code FR0012616852 – ABNX, has announced the results of the Phase 3 AEGIS-II clinical trial for CSL112, a human-plasma-derived apolipoprotein A-I (apoA-I) developed by CSL Behring. The trial aimed to assess the impact of CSL112 on the reduction of major adverse cardiovascular events (MACE) in patients post-acute myocardial infarction (AMI). However, the study did not achieve its primary goal of reducing MACE within 90 days when compared to a placebo.
CER-001, a key product of ABIONYX Pharma, is an innovatively engineered form of human apoA-I designed to replicate the natural structure and biological functions of nascent high-density lipoprotein (HDL), also referred to as pre-β HDL. This engineered protein is capable of executing the entire Reverse Lipid Transport (RLT) pathway, which is the body's natural mechanism for eliminating lipids.
When administered, CER-001 enhances the levels of transient apoA-I and the quantity of HDL particles, facilitating the removal of cholesterol and lipids trapped in tissues. This process does not require the enzyme lecithin-cholesterol acyltransferase (LCAT). Additionally, CER-001 aids in the removal of bacterial lipid endotoxins, such as lipopolysaccharides (LPS), particularly in cases of sepsis. The liver then identifies these HDL particles and eliminates the transported lipids through the RLT process.
ABIONYX Pharma is dedicated to the advancement of groundbreaking treatments for diseases that lack effective therapies, including rare conditions. The company leverages its profound knowledge in lipid science and a unique apoA-I-based technology platform to accelerate the development of new therapeutic solutions. ABIONYX Pharma's mission is to significantly enhance the outcomes of patients in critical care and those suffering from sepsis.