Last update 01 Nov 2024

ER-2001

Last update 01 Nov 2024

Overview

R&D Status

Clinical Result

Translational Medicine

Overview

Basic Info

Drug Type

siRNA

Synonyms

A plasmid encoding a rabies virus glycoprotein tag & lysosome-associated membrane glycoprotein 2 fusion protein gene and a mutant huntingtin small interfering RNA

Target

LAMP-2

Mechanism

LAMP-2 modulators(Lysosome-associated membrane glycoprotein 2 modulators)

Therapeutic Areas

Nervous System DiseasesCongenital DisordersOther Diseases

Active Indication

Huntington Disease

Inactive Indication-

Originator Organization

ExoRNA Bioscience Nanjing Co. Ltd.

Active Organization

ExoRNA Bioscience Nanjing Co. Ltd.

Inactive Organization-

Drug Highest PhasePhase 1

First Approval Date-

RegulationOrphan Drug (US)

Clinical Trials associated with ER-2001

CTR20243121 / Not yet recruitingPhase 1

ER2001注射液治疗早期显性亨廷顿舞蹈病的随机、盲法、安慰剂对照的I期临床研究

[Translation] A randomized, blinded, placebo-controlled phase I clinical study of ER2001 injection in the treatment of early-stage dominant Huntington's disease

评价ER2001注射液在早期显性亨廷顿舞蹈病患者中的安全性和耐受性, 药代动力学,药效动力学,临床疗效,免疫原性及潜在的生物标志物等。

[Translation]

To evaluate the safety and tolerability, pharmacokinetics, pharmacodynamics, clinical efficacy, immunogenicity and potential biomarkers of ER2001 injection in patients with early-stage manifest Huntington's disease.

Start Date-

Sponsor / Collaborator

ExoRNA Bioscience Nanjing Co. Ltd.

NCT06024265 / RecruitingEarly Phase 1

An Open-Label, Dose Escalation Early Phase 1 Study of ER2001 Intravenous Injection in Adults With Early Manifest Huntington's Disease

This is an open label, dose escalation clinic trial of ER2001 intravenous injection to evaluate safety, tolerability and pharmacokinetics of ascending single and multiple doses of intravenously administered ER2001 in patients with early manifest Huntington's Disease. Furthermore, pharmacodynamics in particular target engagement, and early clinical signs of efficacy will be assessed. This study will evaluate increasing doses of ER2001 in sequential cohorts. ER2001 was escalated over 4 dose levels . The planned duration of this treatment is 14 weeks.

Start Date04 Apr 2023

Sponsor / Collaborator

ExoRNA Bioscience Nanjing Co. Ltd.

100 Clinical Results associated with ER-2001

100 Translational Medicine associated with ER-2001

100 Patents (Medical) associated with ER-2001

Literatures (Medical) associated with ER-2001

01 Apr 2006·International Journal of Geriatric PsychiatryQ2 · MEDICINE

Venlafaxine extended-release in patients older than 80 years with depressive syndrome

Q2 · MEDICINE

Article

Author: Carmen Garcia-Calvo ; Rita Prieto ; Miquel Roca ; Enrique Baca

OBJECTIVESThe aim of this evaluation was to assess the efficacy and safety of venlafaxine extended-release (ER) in very old primary care out-patients with depressive syndrome and associated anxiety symptoms.METHODSThis was an observational, naturalistic, multicenter, prospective, open-label study in an outpatient population with a diagnosis of depressive syndrome with anxiety symptoms. Minimum scores of 17 and 10 on the Hamilton Rating Scale for Depression (HAM-D(17)) and Anxiety (HAM-A), respectively, were required. Daily doses of 75 mg to 225 mg of venlafaxine extended release (ER) were administered for 24 weeks. Effectiveness for depressive-anxious symptomatology was assessed using the HAM-D(17) and HAM-A scales.PATIENTSThe 97 patients discussed in this report are a subgroup comprising all elderly patients, aged >or= 80 years, who were part of the larger observational, naturalistic, multicenter, prospective, open-label study and who had received venlafaxine ER for a maximum duration of 24 weeks.RESULTSAt endpoint, remission rates were 57.1% (HAM-D(17) CONCLUSIONSVenlafaxine ER was shown to be an effective and safe drug for the treatment of very elderly primary care patients with depressive syndrome and associated anxiety symptoms.

100 Deals associated with ER-2001

R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Huntington Disease	Phase 1	CN	ExoRNA Bioscience Nanjing Co. Ltd.	20 Aug 2024

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ER-2001

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R&D Status

Clinical Result

Translational Medicine

Deal

Core Patent

Clinical Trial

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Regulation