Posted by Michael Wonder on 19 Jun 2019
Abeona Therapeutics receives FDA fast track designation for ABO-202 AAV9 gene therapy in CLN1 disease
18 June 2019 - Abeona Therapeutics today announced that the U.S. Food and FDA has granted fast track designation to its ABO-202 program.
ABO-202, the Company’s novel one-time AAV9 gene therapy for CLN1 disease, is designed to deliver a functional copy of the PPT1 gene to the central nervous system and peripheral organs using a combination of intravenous and intrathecal administrations.
Abeona is preparing to initiate a Phase 1/2 clinical trial evaluating ABO-202 in patients with CLN1 disease and will provide guidance on the timing of the trial later this year.
