Abeona Therapeutics Inc. announced an oral presentation of additional data from the Company's pivotal Phase 3 VIITAL™ study evaluating its investigational EB-101 for recessive dystrophic epidermolysis bullosa (RDEB). The data presentation occurred earlier on May 11, 2023 during the inaugural International Societies for Investigative Dermatology (ISID) Meeting in Tokyo, Japan. People with RDEB have a defect in the COL7A1 gene, leaving them unable to produce functioning type VII collagen, which is necessary to anchor the dermal and epidermal layers of the skin.

There is currently no approved treatment for RDEB. EB-101 is an autologous, engineered cell therapy currently being developed for the treatment of recessive dystrophic epidersolysis bullosa (R DEB), a rare connective tissue disorder without an approved therapy. The pivotal Phase 3 VIital™ study is a randomized clinical trial that evaluated the efficacy, safety and tolerability of EB-101 in 43 large chronic wound pairs in 11 subjects with RDEB.

Treatment with EB-101 involves using gene transfer to deliver the functional COL7A1 gene into a patient's own skin cells (keratinocytes and its proteins) and transplanting those cells back to the patient. EB-101 is being investigated for its ability to enable normal Type VII collagen expression and to facilitate wound healing. EB-101 has been granted Regenerative Medicine Advanced Therapy, Breakthrough Therapy, Orphan Drug and Rare Pediatric Disease designation by the U.S. FDA.

Abeona produces EB-101 for the VIITAL study at its fully integrated gene and cell therapy manufacturing facility in Cleveland, Ohio. EB-101 is an investigational product not yet approved by the FDA.