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Gene Therapy Trial Browser
Clinical Trial Report
Gene Therapy Trial Report
Summary
Anti-VEGF Gene Therapy Trial for Vestibular Schwannoma
NCTID
NCT06517888
(View at clinicaltrials.gov)
Description
This trial will evaluate the safety and tolerability of a single unilateral administration of one of three dose levels of AAVAnc80-antiVEGF and will evaluate the Akouos delivery device to safely achieve the intended product performance.
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Development Status
Active
Indication
Vestibular Schwannoma
Disease Ontology Term
DOID:3204
Compound Name
AAVAnc80-antiVEGF
Sponsor
Akouos, Inc.
Funder Type
Industry
Recruitment Status
Recruiting
Enrollment Count
27
Results Posted
Not Available
Therapy Information
Target Gene/Variant
Anti-VEGF
Therapy Type
Gene transfer
Therapy Route
In-vivo
Mechanism of Action
Overexpression of protective allele/gene
Route of Administration
Intracochlear
Drug Product Type
Viral vector
Target Tissue/Cell
Delivery System
Viral transduction
Vector Type
AAVAnc80
Editor Type
none
Dose 1
Undisclosed dose 1
Dose 2
Undisclosed dose 2
Dose 3
Undisclosed dose 3
Dose 4
Dose 5
Study Record Dates
Current Stage
Phase1, Phase2
Submit Date
2024-07-19
Completion Date
2029-08
Last Update
2025-03-12
Participation Criteria
Eligible Age
>=18 Years
Standard Ages
Adult, Older adult
Sexes Eligible for Study
ALL
Locations
No.of Trial Sites
3
Locations
United States
Regulatory Information
Has US IND
True
FDA Designations
Recent Updates
Eli Lilly acquired this company in 2022
Resources/Links
News and Press Releases
SEC Form 10-K: 2024 Annual Report
Preclinical Publications
(Presentation) Demonstration of Durable Anti-VEGF Protein Expression and Otic Tolerability Following Intracochlear Delivery of AK-antiVEGF (AAVAnc80-antiVEGF Vector) Across Multiple Doses in Non-human Primates - ARO 2023
(Presentation) Demonstration of Secreted Protein Expression Levels Following Intracochlear Delivery of AK-antiVEGF (AAVAnc80-antiVEGF Vector) Across Multiple Doses in Non-human Primates - ARO 2022