CER-001 Atherosclerosis Regression ACS Trial

Phase 2 Completed 301 enrolled Cerenis Therapeutics, SA South Australian Health and Medical Research Institute · collab

RandomizedParallel-groupQuadruple-blindTreatment

Summary

The purpose of this study is to assess the impact of ten intravenous infusions of 3 mg/kg CER 001 vs. placebo, given at weekly intervals for ten weeks, on atherosclerotic plaque volume as measured by coronary IVUS, when administered to subjects presenting with Acute Coronary Syndrome (ACS) with significant plaque volume.

Timeline

Start: 2015-08
Primary completion: 2016-11
Completion: 2016-12

Outcome

Missed primary endpoint

paper The primary efficacy measure, PAV, decreased 0.41% with placebo (P = .005 compared with baseline), but not with CER-001 PMID 30046828 ↗

paper between group differences, 0.32%; P = .15 PMID 30046828 ↗

paper CONCLUSIONS AND RELEVANCE: Infusion of CER-001 did not promote regression of coronary atherosclerosis in statin-treated patients with ACS and high plaque burden. PMID 30046828 ↗

Publications

Nicholls SJ, Andrews J, Kastelein JJP, Merkely B, Nissen SE, Ray KK, Schwartz GG, Worthley SG, Keyserling C, Dasseux JL, Griffith L, Kim SW, Janssan A, Di Giovanni G, Pisaniello AD, Scherer DJ, Psaltis PJ, Butters J. Effect of Serial Infusions of CER-001, a Pre-beta High-Density Lipoprotein Mimetic, on Coronary Atherosclerosis in Patients Following Acute Coronary Syndromes in the CER-001 Atherosclerosis Regression Acute Coronary Syndrome Trial: A Randomized Clinical Trial. JAMA Cardiol. 2018 Sep 1;3(9):815-822. doi: 10.1001/jamacardio.2018.2121.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	CER-001	Protein / enzyme biologic	3 mg/kg	—