drugset

Drugs / CSL112

Follow last change Feb 2024 re-read 3 minutes ago

CSL112

also known as apolipoprotein A-I [human] · apoA-I · apoA-I [human]

Protein / enzyme biologic

Developed for: acute myocardial infarction · atherosclerosis
Investigated by: CSL Behring · CSL Limited

Trials 6

today NCT02742103 · Ph 2 NCT02427035 · Ph 1 NCT02108262 · Ph 2 NCT01499420 · Ph 2 NCT01281774 · Ph 1 NCT01129661 · Ph 1

201020112012201320142015201620172018201920202021202220232024202520262027

Phase	Registry id	Dates	Indication	Sponsor	Status	Outcome
Phase 13 trials
Phase 1	NCT02427035	May → Nov 2015	acute myocardial infarction	CSL Behring	Completed	No outcome recorded
Phase 1	NCT01281774	Jan → Jun 2011	—	CSL Limited	Completed	No outcome recorded
Phase 1	NCT01129661	Jun → Dec 2010	—	CSL Limited	Completed	No outcome recorded
Phase 23 trials · 1 met primary
Phase 2	NCT02742103	Aug 2016 → Jun 2017	acute myocardial infarction	CSL Behring	Completed	Mixed
Phase 2	NCT02108262	Aug 2014 → Dec 2015	acute myocardial infarction	CSL Behring	Completed	Met primary
Phase 2	NCT01499420	Feb → Dec 2012	atherosclerosis	CSL Limited	Completed	No outcome recorded

News releases announcing trial results or a regulatory action · 4

Date	Issuer	Release
2024-02-11	CSL Behring	Results CSL Announces Top-line Results from the Phase 3 AEGIS-II Trial Evaluating the Efficacy and Safety of CSL112 (apolipoprotein A-I [human]) csl.com ↗
2016-11-15	CSL Behring	Results CSL Behring Presents Positive Results from the CSL112 AEGIS-I Phase 2b Trial csl.com ↗ CSL Behring today announced positive results from AEGIS-I, a Phase 2b safety and proof of mechanism clinical study of CSL112, a novel apolipoprotein A-I (apoA-I) infusion therapy.
2014-11-18	CSL Behring	Results CSL112 Found to Elevate Cholesterol Efflux in Patients with Coronary Artery Disease and Mechanism for Rapid Cholesterol Efflux Capacity Demonstrated csl.com ↗
2013-11-20	CSL Behring	Results Phase 2a Findings Demonstrate that CSL112, A Novel Apolipoprotein A-I Infusion Therapy, Has a Favorable Safety Profile, is Well Tolerated and Increases Cholesterol Efflux Capacity in Stable Atherothrombotic Patients csl.com ↗ Results of a Phase 2a trial of CSL112, sponsored by CSL Limited, demonstrated favorable safety and tolerability when administered to patients with stable atherothrombotic disease.

All press releases naming this drug 7 releases

Date	Issuer	Release
2024-02-11	CSL Behring	CSL Announces Top-line Results from the Phase 3 AEGIS-II Trial Evaluating the Efficacy and Safety of CSL112 (apolipoprotein A-I [human]) csl.com ↗
2020-11-05	CSL Behring	CSL Behring Publishes Design for First-Ever Outcomes Study of ApoA-I to Reduce Risk of Cardiovascular Events in Heart Attack Patients csl.com ↗
2018-03-23	CSL Behring	CSL Behring Announces First Patient Enrollment in Phase 3 Clinical Trial of CSL112 to Assess Reduction of Early Recurrent Cardiovascular Events in Heart Attack Survivors csl.com ↗
2016-11-15	CSL Behring	CSL Behring Presents Positive Results from the CSL112 AEGIS-I Phase 2b Trial csl.com ↗
2014-11-18	CSL Behring	CSL112 Found to Elevate Cholesterol Efflux in Patients with Coronary Artery Disease and Mechanism for Rapid Cholesterol Efflux Capacity Demonstrated csl.com ↗
2014-11-10	CSL Behring	CSL Limited Launches AEGIS-I, a Phase 2b Clinical Study of CSL112, a Novel Apolipoprotein A-I Infusion Therapy Designed to Rapidly Remove Cholesterol from Arteries and Stabilize Plaque csl.com ↗
2013-11-20	CSL Behring	Phase 2a Findings Demonstrate that CSL112, A Novel Apolipoprotein A-I Infusion Therapy, Has a Favorable Safety Profile, is Well Tolerated and Increases Cholesterol Efflux Capacity in Stable Atherothrombotic Patients csl.com ↗

Evidence & citations 6 cited values

Every value below carries the sentence it was read from. 8 sources stand behind the page.

Field	Value	Cited text
Known as	CSL112	“The CSL112-2001 trial: Safety and tolerability of multiple doses of CSL112 (apolipoprotein A-I [human]), an intravenous formulation of plasma-derived apolipoprotein A-I, among...” PMID 30580130 ↗ Nov 2018 5 NCT01499420 ↗ NCT02427035 ↗ NCT01129661 ↗ NCT02108262 ↗ NCT01281774 ↗
Known as	apoA-I	“AIMS: To characterize relationships between apolipoprotein A-I (apoA-I) exposure and cholesterol efflux capacity (CEC) and covariate effects following CSL112 (apoA-I [human])...” PMID 33217027 ↗ Dec 2020
Known as	apoA-I [human]	“following CSL112 (apoA-I [human]) administration in an integrated population including acute myocardial infarction (AMI) patients” PMID 33217027 ↗ Dec 2020
Known as	apolipoprotein A-I [human]	“The CSL112-2001 trial: Safety and tolerability of multiple doses of CSL112 (apolipoprotein A-I [human]), an intravenous formulation of plasma-derived apolipoprotein A-I, among...” PMID 30580130 ↗ Nov 2018 1 “Pharmacokinetics and Safety of CSL112 (Apolipoprotein A-I [Human]) in Adults With Moderate Renal Impairment and Normal Renal Function.” PMID 30240132 ↗ Sep 2018
Modality	Protein / enzyme biologic	“CSL112 (apoA-I [human])” PMID 33217027 ↗ Dec 2020
Route	Intravenous	“Single escalating intravenous doses of CSL112” NCT01129661 ↗