Abeona Therapeutics® Announces Publication in The Lancet of Phase 3 VIITAL™ Study Data in Recessive Dystrophic Epidermolysis Bullosa

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- RDEB is a lifelong debilitating, blistering skin disease associated with large and painful wounds that often remain open for years and cause significant clinical burden, including pain, itch, and risk of squamous cell carcinoma - - ZEVASKYN™ (prademagene zamikeracel) demonstrated significant wound healing and pain reduction after a single treatment with a favorable safety profile in large chronic RDEB wounds - - ZEVASKYN is the first and only autologous cell-based gene therapy FDA-approved to treat RDEB wounds in adult and pediatric patients - CLEVELAND , June 24, 2025 (GLOBE NEWSWIRE) -- Abeona Therapeutics Inc. (Nasdaq: ABEO) today announced that The Lancet has published results from the pivotal Phase 3 VIITAL study (NCT04227106) evaluating the efficacy and safety of ZEVASKYN (prademagene zamikeracel) gene-modified cellular sheets, also known as pz-cel, for the treatment of wounds in adult and pediatric patients with recessive dystrophic epidermolysis bullosa (RDEB). This article, titled, “Prademagene Zamikeracel for Recessive Dystrophic Epidermolysis Bullosa Wounds (VIITAL): A Two-Centre, Randomised, Open-Label, Intrapatient-Controlled Phase 3 Trial,” representing the primary publication of the full VIITAL study data, is now available online and will be published in a future print issue of The Lancet . Jean Tang , M.D., Ph.D., Professor of Dermatology, Stanford University School of Medicine , Principal Investigator of the ZEVASKYN Phase 3 VIITAL study and lead author of The Lancet publication said, "People with RDEB endure incredibly fragile skin, leading to severe, painful wounds that can last for years, and lead to systemic complications impacting the length and quality of life. Our VIITAL study showed ZEVASKYN was well tolerated and significantly improved wound healing and pain in large chronic RDEB wounds after just a single treatment. We hope sharing these important findings, including our work published in The Lancet , raises awareness for RDEB and helps improve the lives of patients." RDEB, a rare genetic blistering disorder, is characterized by severe skin wounds that cause pain and can lead to systemic complications impacting the length and quality of life. People with RDEB have a defect in both copies of the COL7A1 gene, leaving them unable to produce functioning type VII collagen, which forms anchoring fibrils necessary to secure the dermal and epidermal layers of the skin. Lack of anchoring fibrils leads to fragile skin that blisters easily, and patients can suffer from years of painful wounds and itch. RDEB patients also have high risk of developing squamous cell carcinoma (SCC). There is no cure for RDEB and ZEVASKYN is the only product approved by the U.S. Food and Drug Administration (FDA) to treat RDEB wounds with a single application. “The publication of our VIITAL study results in The Lancet , a respected global medical journal, marks a significant achievement as our U.S. launch of ZEVASKYN is underway, with the first patient expected to be treated in the third quarter of 2025,” said Vish Seshadri , Chief Executive Officer of Abeona. “We deeply appreciate the invaluable participation of patients and their families in the VIITAL study, along with the scientific community's critical contributions to advancing effective treatment options for RDEB.” VIITAL was an intra-patient randomized, open-label, controlled, Phase 3 study to compare the efficacy and safety of a single application of ZEVASKYN in 11 patients with RDEB, focusing on 43 pairs of their large chronic wounds. These wounds, each at least 20 cm² and open for a median duration of 5 years (ranging from 6 months to 21 years), were assessed against two co-primary endpoints at six months (week 24), comparing treated to matched untreated (control) wounds. The VIITAL study builds on the clinical experience from the Phase 1/2a study of ZEVASKYN (NCT01263379), a single center, open label study in 38 chronic wounds across 7 patients. The Phase 1/2a study showed that a single surgical application of ZEVASKYN was associated with long-term improvement at treated sites over a median follow-up of 6.9 years (range 4 to 8 years). Long-term follow up data and quality of life data from the Phase 1/2a study were published in Orphanet Journal of Rare Diseases . Highlights from the VIITAL study Both co-primary endpoints of wound healing and pain reduction were met. 81% of treated wounds (35/43) were healed by 50% or more from baseline as compared with 16% of control wounds (7/43) at week 24 (P

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