Abeona Therapeutics announced that the U.S. FDA has removed its clinical hold on the company’s pivotal Phase 3 clinical trial evaluating gene therapy for the treatment of recessive dystrophic epidermolysis bullosa (RDEB).
Following the NY-based biopharma's submission of additional data points on transport stability, the FDA provided clearance to proceed with the VIITAL study evaluating EB-101 for the treatment of a rare connective tissue disorder without an approved therapy.
Treatment with EB-101 involves using gene transfer to deliver COL7A1 genes into a patient’s own skin cells and transplanting them back to the patient to enable normal Type VII collagen expression and facilitate wound healing. In the U.S., Abeona holds Regenerative Medicine Advanced Therapy, Breakthrough Therapy, and Rare Pediatric designations for EB-101 and Orphan Drug designation in both the U.S. and EU.
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