Approval Year
Substance Class |
Protein
Created
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admin
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Sat Dec 16 19:36:51 GMT 2023
by
admin
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Sat Dec 16 19:36:51 GMT 2023
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Protein Sub Type | |
Record UNII |
V9526P2UXZ
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Record Status |
Validated (UNII)
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Record Version |
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Common Name | English | ||
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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
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Code System | Code | Type | Description | ||
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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
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PRIMARY | |||
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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
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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. | ||
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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
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PRIMARY |
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TARGET->MIMETIC |
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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).
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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
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ACTIVE MOIETY |
Capstone Therapeutics Announces Phase 1b/2a Study Results for AEM-28 Showing Safety and Biomarker Efficacy Signals
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Name | Property Type | Amount | Referenced Substance | Defining | Parameters | References |
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MOL_WEIGHT:NUMBER(CALCULATED) | CHEMICAL |
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Molecular Formula | CHEMICAL |
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