B/BE/25/BVW5 - Information sheet for the public (prepared by the notifier)Public information according to the provisions of Directive 2001/18/EC
Long title
A phase 2, adaptive, double-blinded, placebo controlled, randomized, multi-center trial to evaluate the efficacy, safety and tolerability of intracoronary infusion of AB-1002 in adult subjects with New York Heart Association (NYHA) Class III heart failure and non-ischemic cardiomyopathy
Date receipt dossier
EU record number
B/BE/25/BVW5
EudraCT number
2024-510581-17-00
Company / Sponsor
Asklepios BioPharmaceutical (AskBio)
Phase
II
Treated organism
Humans
Indication category
Congestive Heart failure
Disease
NYHA Class III heart failure and non-ischemic cardiomyopathy
Therapeutic approach
Gene therapy
Genetic modification
Non-replicating recombinant vector derived from adeno-associated virus AAV2i8 carrying the transgene encoding for the human activated Inhibitor-1c ( I-1c)
Method of transfer of nucleic acid of interest
Non-replicating recombinant vector derived from adeno-associated virus AAV2/AAV8
Administered biological material
Genetically modified virus
Route of administration
Intracoronary
Locations in Belgium
AZORG in Aalst
UZ Antwerpen in Edegem
UZ Gent in Gent
AZ Delta in Roeselare
UZ Antwerpen in Edegem
UZ Gent in Gent
AZ Delta in Roeselare
Nr of subjects
Up to 150 patients overall and 5 patients in Belgium
Foreseen duration
from Aug.2025 till 31.12.2030
Type of procedure
Contained use and Deliberate release
Current status
Authorized