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Approval Year

Substance Class Protein
Created
by admin
on Sat Dec 16 19:36:51 GMT 2023
Edited
by admin
on Sat Dec 16 19:36:51 GMT 2023
Protein Sub Type
Record UNII
V9526P2UXZ
Record Status Validated (UNII)
Record Version
  • Download
Name Type Language
AEM-28
Common Name English
AC-HE18A-NH2
Common Name English
AC-LEU-ARG-LYS-LEU-ARG-LYS-ARG-LEU-LEU-ARG-ASP-TRP-LEU-LYS-ALA-PHE-TYR-ASP-LYS-VAL-ALA-GLU-LYS-LEU-LYS-GLU-ALA-PHE-NH2
Systematic Name English
Classification Tree Code System Code
FDA ORPHAN DRUG 381712
Created by admin on Sat Dec 16 19:36:51 GMT 2023 , Edited by admin on Sat Dec 16 19:36:51 GMT 2023
Code System Code Type Description
PUBCHEM
16143342
Created by admin on Sat Dec 16 19:36:51 GMT 2023 , Edited by admin on Sat Dec 16 19:36:51 GMT 2023
PRIMARY
CLINICAL_TRIALS.GOV
AEM-28
Created by admin on Sat Dec 16 19:36:51 GMT 2023 , Edited by admin on Sat Dec 16 19:36:51 GMT 2023
PRIMARY ClinicalTrials.gov Identifier: NCT02100839; The purpose of the first part of this study is to determine the safety and tolerability of a single dose of AEM-28, an apolipoprotein E mimetic, in subjects with high total cholesterol who are otherwise healthy subjects. The pharmacokinetics and pharmacodynamics of AEM-28 will also be evaluated. The second part of this study will be a multiple ascending dose evaluation of AEM-28 in patients with refractory hypercholesterolemia.AEM-28 has demonstrated significant lipid lowering activity and positive effects on the artery wall. AEM-28 is being developed for the treatment of homozygous familial hypercholesterolemia.
FDA UNII
V9526P2UXZ
Created by admin on Sat Dec 16 19:36:51 GMT 2023 , Edited by admin on Sat Dec 16 19:36:51 GMT 2023
PRIMARY
Related Record Type Details
TARGET->MIMETIC
Related Record Type Details
ACTIVE MOIETY
Ac-hE18A-NH2 induced a 2.5 fold increase in pre.BETA.-HDL in the conditioned media of HepG2 cells. This effect persisted for three days after removal of the peptide from culture medium. Ac-hE18A-NH2 also induced the secretion of cell-surface apoE from THP-1 macrophages. In addition, the peptide increased cholesterol efflux from THP-1 cells by an ABCA-1 independent mechanism. Moreover, Ac-hE18A-NH2 inhibited LPS-induced vascular cell adhesion molecule-1 (VCAM-1) expression, and reduced monocyte adhesion in human umbilical vein endothelial cells (HUVECs).
ACTIVE MOIETY
Class: Antihyperlipidaemic, Apolipoprotein therapeutic and Peptide; Mechanism of Action: Apolipoprotein B modulator, Apolipoprotein E agonist and Cholesterol modulator; Orphan Drug Status: Yes - Hyperlipoproteinaemia type IIa; Highest Development Phases: Phase II Hypercholesterolaemia and Hyperlipoproteinaemia type IIa; Most Recent Events: 14 Oct 2015 Capstone Therapeutics receives patent allowance for AEM 28 in USA, 16 Dec 2014 Adverse events and Efficacy data from a phase Ib/IIa trial in Hypercholesterolaemia released by Capstone Therapeutics
ACTIVE MOIETY
Capstone Therapeutics Announces Phase 1b/2a Study Results for AEM-28 Showing Safety and Biomarker Efficacy Signals
Name Property Type Amount Referenced Substance Defining Parameters References
MOL_WEIGHT:NUMBER(CALCULATED) CHEMICAL
Molecular Formula CHEMICAL