apoA-I (CSL112) / CSL Behring - LARVOL DELTA

EFFICACY AND SAFETY OF CSL112 IN ENHANCING CHOLESTEROL EFFLUX AND HDL FUNCTION: A SYSTEMATIC REVIEW AND META-ANALYSIS (CHEST 2026) - No abstract available

Retrospective data • Review • Acute Coronary Syndrome • Cardiovascular • Gene Therapies • Ischemic stroke • Myocardial Ischemia • Reperfusion Injury

No genetic evidence for an association of apolipoprotein A-I with cardiovascular outcomes at different LDL cholesterol levels: drug-target Mendelian randomization analyses. (PubMed, Atherosclerosis) - "Genetically proxied lifelong elevation of apoA-I concentration was not associated with reduced cardiovascular risk, even among individuals with high residual LDL-C."

Journal • Cardiovascular • Coronary Artery Disease • Heart Failure • Myocardial Infarction • APOA1

Efficacy and safety of CSL112 (apolipoprotein A-I) on modulation of HDL-Related biomarkers and reverse cholesterol transport in atherosclerosis and myocardial infarction: a systematic review and meta-analysis. (PubMed, Expert Rev Cardiovasc Ther) - "CSL112 significantly enhances CEC and HDL-C levels with favorable safety profile with the 6 g dose at 2 hours, supporting its use as adjunctive therapy for immediate cardiovascular protection. Large outcome-driven trials are warranted to define long-term clinical benefits."

Biomarker • Journal • Retrospective data • Review • Atherosclerosis • Cardiovascular • Myocardial Infarction • ABCA1 • APOA1

Apolipoprotein A-I (CSL112) and Cardiovascular Outcomes in Atherosclerotic Cardiovascular Disease: A Scoping Review. (PubMed, Clin Cardiol) - "ApoA-I remains a promising biomarker and therapeutic target in ASCVD, though its clinical application is complicated by biological and methodological variability. Future research focusing on gene therapies, small molecule modulators, and ApoA-I mimetics may enhance its functional properties and clinical utility. Integrating ApoA-I into personalized treatment strategies could improve cardiovascular outcomes and reduce disease burden."

Biomarker • Journal • Review • Atherosclerosis • Cardiovascular • Gene Therapies • APOA1

Precision approach in apoA-I infusion trials: When CSL112 may actually work. (PubMed, J Clin Lipidol) - "We integrate ATP-binding cassette transporter A1 (ABCA1) biology with subgroup trial findings to propose a precision-stratification framework for future apoA-I infusion trials. We focus on the interaction of lipid burden and inflammation on ABCA1 transporter function, the impact of statin-induced transporter downregulation, and strategies for patient selection, including ex vivo efflux assays and molecular transporter profiling, and the therapeutic promise of combination therapies (apoA-I infusion with liver X receptor agonists) in patients with impaired transporter function."

Journal • Cardiovascular • Dyslipidemia • Inflammation • Myocardial Infarction • ABCA1 • APOA1

High-Density Lipoprotein Dysfunction and Atherosclerotic Cardiovascular Disease: From Quantity to Quality. (PubMed, Cardiol Rev) - "Despite the promising therapies such as cholesterol ester transfer protein (CETP) inhibitors, niacin, and apolipoprotein A-I infusions (reconstituted high-density lipoprotein (CSL112)), none have yet demonstrated definitive event reduction. Future directions include standardizing HDL functional assays, prioritizing quality over concentration, and integrating HDL-targeted and metabolic therapies, including glucagon-like peptide-1 (GLP-1) receptor agonists and sodium-glucose transport 2 (SGLT2) inhibitors, to restore HDL's protective phenotype and redefine preventive cardiology."

Journal • Atherosclerosis • Cardiovascular • Inflammation • APOA1 • MPO

Apolipoprotein A (ApoA) in Neurological Disorders: Connections and Insights. (PubMed, Int J Mol Sci) - "Clinical trials, such as those with CSL112, highlight the need for neuro-specific optimization. Further research should prioritize human-relevant models, advanced neuroimaging techniques, and functional assays to elucidate ApoA mechanisms inside the central nervous system. The integration of genetic, lipidomic, and clinical data offers potential for enhancing precision medicine in neurological illnesses by facilitating the generation of ApoA-targeted treatments and bridging current deficiencies in disease comprehension and therapy."

Journal • Review • Alzheimer's Disease • Cardiovascular • CNS Disorders • Inflammation • Metabolic Disorders • Movement Disorders • Multiple Sclerosis • Parkinson's Disease • APOA1 • APOA2 • APOA5

The challenges in improving myocardial infarction outcomes and the year 2024 in a nutshell. (PubMed, Future Cardiol) - No abstract available

Journal • Cardiovascular • Myocardial Infarction

Advancing Secondary Prevention Post-Myocardial Infarction With CSL112. (PubMed, JACC Basic Transl Sci) - No abstract available

Journal • Cardiovascular • Myocardial Infarction

Apolipoprotein A1 (CSL112) Increases Lecithin-Cholesterol Acyltransferase Levels in HDL Particles and Promotes Reverse Cholesterol Transport. (PubMed, JACC Basic Transl Sci) - "CSL112 reduced levels of apolipoproteins A2, B, C, and E and serum amyloids A1 and A4, whereas ApoA1, ApoM, and lecithin-cholesterol acyltransferase were significantly elevated. Increased CEC, plasma HDL cholesterol levels, CER, and CEC also were observed in CSL112-treated patients."

Journal • Cardiovascular • Myocardial Infarction • APOA1

Impact of Apolipoprotein A-I Infusions on Cardiovascular Events Post-MI by Neutrophil-Lymphocyte Ratio and LDL-Cholesterol Levels. (PubMed, JACC Adv) - P3 | "Baseline elevated NLR predicts MACE in post-AMI patients, and CSL112 showed an associated reduction in MACE in patients with elevated NLR and LDL-C ≥100 mg/dL."

Journal • Cardiovascular • Coronary Artery Disease • Dyslipidemia • Inflammation • Myocardial Infarction • APOA1

APOLIPOPROTEIN A-I INFUSIONS AND CARDIOVASCULAR OUTCOMES IN PATIENTS WITH ACUTE MYOCARDIAL INFARCTION AND MODERATE RENAL IMPAIRMENT: INSIGHTS FROM THE AEGIS-II TRIAL - Gerald Chi (ACC 2025) - P3 | "In the subgroup of patients with moderate renal impairment, treatment with CSL112 was associated with a significant reduction in the risk of CV death, MI, or stroke at 180 and 365 days compared to placebo."

Clinical • Cardiovascular • Chronic Kidney Disease • Coronary Artery Disease • Myocardial Infarction • Nephrology • Renal Disease • APOA1

APOLIPOPROTEIN A-I INFUSIONS AND CARDIOVASCULAR OUTCOMES IN ACUTE MYOCARDIAL INFARCTION ACCORDING TO NEUTROPHIL-LYMPHOCYTE RATIO AND BASELINE LDL-CHOLESTEROL LEVELS: INSIGHTS FROM THE AEGIS-II TRIAL - Sem Rikken (ACC 2025) - P3 | "Higher NLR was associated with a higher risk of MACE. CSL112 may reduce MACE in participants with both higher NLR and LDL-C ≥100 mg/dL."

Cardiovascular • Myocardial Infarction • APOA1

Quo Vadis after AEGIS: New Opportunities for Therapies Targeted at Reverse Cholesterol Transport? (PubMed, Curr Atheroscler Rep) - "However, the AEGIS-II trial of CSL112, an apolipoprotein A-I therapy that enhances cholesterol efflux, did not meet its primary endpoint...The role of HDL therapeutics in patients with familial hypercholesterolaemia, inherited low HDL-cholesterol and impaired HDL function, especially with inadequately controlled LDL-cholesterol, merits further investigation. The treatment of patients with monogenic defects in HDL metabolism remains a significant gap in care that needs further research."

Journal • Review • Atherosclerosis • Cardiovascular • Coronary Artery Disease • Dyslipidemia • Familial Hypercholesterolemia • APOA1

Apolipoprotein A1 infusion in patients with Acute Myocardial Infarction: A Systematic Review and Meta-analysis of randomized trials (AHA 2024) - "Our findings suggest that the administration of CSL112 was not associated with a reduction in mortality, SAE or MACE in patients with acute myocardial infarction."

Retrospective data • Review • Cardiovascular • Myocardial Infarction • APOA1

The impact of CSL112 and atorvastatin on lipid core stiffness in murine atherosclerotic plaques (AHA 2024) - "Statistical analysis indicated that CSL112 significantly increased the elastic modulus of lipid cores compared to both atorvastatin and saline (p <0.001), while lipid stiffness was also significantly higher in the atorvastatin group compared to saline (p = 0.039).Conclusion. The increase in lipid pool stiffness within atherosclerotic plaques treated with CSL112 and atorvastatin may reduce the level of PSS and enhance plaque structural stability."

Preclinical • Atherosclerosis • Dyslipidemia • APOA1 • APOE

Infusion of human apolipoprotein A-I (CSL112) promotes several aspects of reverse cholesterol transport (AHA 2024) - "CSL112 altered HDL composition and increased HDL functionality by promoting multiple steps of the reverse cholesterol transport pathway."

Cardiovascular • Myocardial Infarction • APOA1 • SAA1

ApoA-I Infusions and Burden of Ischemic Events After Acute Myocardial Infarction: Insights From the AEGIS-II Trial. (PubMed, J Am Coll Cardiol) - P3 | "In this prespecified exploratory analysis of the AEGIS-II trial, 4 weekly infusions of CSL112 among high-risk patients after AMI significantly reduced the total burden of nonfatal ischemic events and CV death at 180 and 365 days compared with placebo. (AEGIS-II [Study to Investigate CSL112 in Subjects With Acute Coronary Syndrome]; NCT03473223)."

Journal • Acute Coronary Syndrome • Cardiovascular • Coronary Artery Disease • Myocardial Infarction • APOA1

Apolipoprotein A-I Infusions and Cardiovascular Outcomes in Acute Myocardial Infarction According to Baseline LDL-Cholesterol Levels: The AEGIS-II Trial. (PubMed, Eur Heart J) - P3 | "In this population, treatment with CSL112 compared to placebo was associated with a significantly lower risk of recurrent cardiovascular events among patients with a baseline LDL-C ≥100 mg/dL. Further studies need to confirm that CSL112 efficacy is influenced by baseline LDL-C."

Journal • Cardiovascular • Coronary Artery Disease • Dyslipidemia • Myocardial Infarction • APOA1

New perspectives on the high-density lipoprotein system and its role in the prevention and treatment of atherosclerotic cardiovascular disease. (PubMed, Curr Opin Endocrinol Diabetes Obes) - "Qualitative markers of HDL may be causally related to CVD. There is a need for ongoing research into HDL therapeutics that promote the biological properties of HDL. The optimal cohort or disease state that will benefit from these therapies needs to be identified."

Journal • Atherosclerosis • Cardiovascular • Dyslipidemia • APOA1

CSL112 and HDL function hypothesis - a never-ending wait. (PubMed, Expert Rev Clin Pharmacol) - No abstract available

Journal • Cardiovascular • Myocardial Infarction

Highlights of Cardiovascular Disease Prevention Studies Presented at the 2024 American College of Cardiology Conference. (PubMed, Curr Atheroscler Rep) - "The LIBerate-HR trial showed the efficacy and safety of lerodalcibep, a subcutaneous injection that prevents binding of Pro-Protein Convertase Subtilisin/Kexin (PCSK) 9 to low-density lipoprotein (LDL)-receptors resulting in LDL-cholesterol (LDL-C) lowering in patients at very high risk or high risk of atherosclerotic CV disease (ASCVD). The AEGIS-II randomized patients with type 1 myocardial infarction (MI) with multivessel coronary artery disease and additional CV risk factors and found no benefit in major adverse CV events (MACE) with CSL112, an apolipoprotein A1 infusion shown to increase cholesterol efflux capacity. The Bridge-TIMI 73a trial showed a significant reduction in triglyceride (TG) levels with olezarsen, an antisense mRNA, in patients with moderate hyperTG with elevated CV risk...The VICTORIAN-INITIATE trial showed efficacy and safety in early use of inclisiran in patients with ASCVD who did not reach target LDL-C < 70 mg/dL despite maximally..."

Journal • Review • Atherosclerosis • Cardiomyopathy • Cardiovascular • Coronary Artery Disease • Diabetes • Dyslipidemia • Metabolic Disorders • Myocardial Infarction • Type 2 Diabetes Mellitus • AKR1B1 • APOA1

Enhancing HDL Function to Prevent Atherothrombosis: Is it Time to Efflux the HDL Hypothesis? (PubMed, J Am Coll Cardiol) - No abstract available

Journal • Acute Coronary Syndrome • Cardiovascular • Hematological Disorders • Myocardial Infarction • Thrombosis

Can CSL-112 Revolutionize Atherosclerosis Treatment? A Critical Look at the Evidence. (PubMed, Curr Probl Cardiol) - "Larger, well-designed trials with longer follow-up periods are necessary to definitively establish its clinical benefit and safety profile before widespread clinical use can be considered. Future research should also explore deeper into the pharmacokinetic and pharmacodynamic profile of CSL-112 and explore its efficacy and safety in different patient subgroups."

Journal • Review • Atherosclerosis • Cardiovascular • Dyslipidemia • Immunology • Myocardial Infarction • APOA1

CSL112 (Apolipoprotein A-I [Human]) Reduces the Elevation in Neutrophil-to-Lymphocyte Ratio Induced by Acute Myocardial Infarction. (PubMed, J Am Heart Assoc) - No abstract available

Journal • Cardiovascular • Inflammation • Myocardial Infarction • APOA1