Last update 20 Mar 2025

AB-1005

Overview

Basic Info

Drug Type
AAV based gene therapy
Synonyms
AAV2-GDNF gene therapy (Asklepios BioPharmaceutical), AAV2-GDNF-MSA, AAV2-GDNF-PD
+ [5]
Action
modulators
Mechanism
GDNF modulators(Glial cell line-derived neurotrophic factors modulators)
Inactive Indication-
Originator Organization
Active Organization
Inactive Organization-
Drug Highest PhasePhase 2
First Approval Date-
RegulationFast Track (United States), Regenerative Medicine Advanced Therapy (United States)
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R&D Status

10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Parkinson DiseasePhase 2
United States
11 Jun 2024
Multiple System AtrophyPhase 1
United States
30 Nov 2022
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 1
11
(ebfkctdtyp) = The study met its primary objective, no attributed serious adverse events in all 11 patients at 18 months gggbecsouw (fckstdxpel )
Met
Positive
04 Jan 2024
Not Applicable
-
(Moderate PD participants)
rnintoxzhd(gszlybvzqu) = Asymptomatic, unilateral neuroimaging findings (3 of 22 infusions) were identified on scheduled 6-month MRIs wzgelizygc (evlwxmrary )
-
11 Oct 2022
Phase 1
10
ydrqimylnx(rncttnyzeg) = No AAV2-GDNF associated SAEs have been reported uovetlgczm (zkpixtuqkr )
Positive
02 May 2022
Placebo
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Approval

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Regulation

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