Table 1.

Clinical studies and characteristics of apolipoprotein A-I infusion therapies

	MDCO-216	CER-001	CSL112
ApoA-I source	Recombinant apoA-I Milano	Recombinant wild-type apoA-I	Native apoA-I isolated from human plasma
Phospholipid	POPC	SM and DPPG in a molar ratio of 32.3:1	Mixed PCs isolated from soy
Protein/phospholipid ratio	1:1.1	1:2.7	1:1.4
Phase IIb study	MILANO-PILOT	CARAT	AEGIS-I trial
Tested patient population	Acute coronary syndrome	Acute coronary syndrome	Acute coronary syndrome
Primary outcome	Coronary atherosclerotic plaque regression in the treatment group	Coronary atherosclerotic plaque regression in the treatment group	Hepatic and renal safety and tolerability of CSL112
Dose mg/kg	20	3	80 (est)
Dose (total), g	1.5 (est)	0.225 (est)	6
Timing of first infusion from first medical contact, days	14	14	5
Dose frequency	Weekly	Weekly	Weekly
Number of doses	5	10	4
	Acute response
ApoA-1 level, % change	− 4	+ 6*	+ 106
HDL-C level, % change	− 8	NA	+ 26
ABCA1-mediated CEC, % change	+ 80–90	+ 14*	+ 242
LCAT activity

^*Parameters are not available in the CARAT study; data from Zheng KH et al. [69] 2016

Abbreviations: ABCA1, ATP-binding cassette protein A1; AEGIS-I, ApoA-I Event Reducing in Ischemic Syndromes I; ApoA-1, apolipoprotein A-I; CARAT, CER-001 Atherosclerosis Regression Acute Coronary Syndrome Trial; CEC, cholesterol efflux capacity; DPPG, dipalmitoylphosphatidylglycerol; est, estimated; HDL-C, high-density lipoprotein cholesterol; MILANO-PILOT, MDCO-216 Infusions Leading to Changes in Atherosclerosis: a Novel Therapy in Development to Improve Cardiovascular Outcomes—Proof of Concept IVUS, Lipids, and Other Surrogate Biomarkers; NA, not applicable; PC, phosphatidylcholine; POPC, 1-palmitoyl-2-oleoylphosphocholine; SM, sphingomyelin; LCAT, lecithin cholesterol acyltransferase