Abeona Therapeutics Announces Completion of Patient Follow-up in Pivotal Phase 3 VIITAL™ Study ...
Abeona Therapeutics Inc. (Nasdaq: ABEO) today announced that the last patient has completed their 6-month follow-up visit in Abeona’s pivotal Phase 3 VIITAL™ study of its investigational autologous, engineered cell therapy, EB-101, in patients with recessive dystrophic epidermolysis bullosa (RDEB)
NEW YORK and CLEVELAND, Oct. 04, 2022 (GLOBE NEWSWIRE) -- Abeona Therapeutics Inc. (Nasdaq: ABEO) today announced that the last patient has completed their 6-month follow-up visit in Abeona’s pivotal Phase 3 VIITAL™ study of its investigational autologous, engineered cell therapy, EB-101, in patients with recessive dystrophic epidermolysis bullosa (RDEB).
“Completion of the last patient’s 6-month follow-up visit marks a key milestone that enables us to report key findings from our Phase 3 VIITAL™ study of EB-101 in RDEB,” said Vish Seshadri, Chief Executive Officer of Abeona. “We thank the patients, their families, and the clinical investigators, and plan to report topline results from this pivotal study within the next month.”
Abeona has been verifying and preparing the data in real time to ensure that an efficient database lock can be completed within two to three weeks from the last patient’s final visit. Abeona expects the VIITAL™ study, if positive, to serve as the basis for seeking approval by the U.S. Food and Drug Administration (FDA) of EB-101 for the treatment of patients with RDEB.
About Recessive Dystrophic Epidermolysis Bullosa
Recessive dystrophic epidermolysis bullosa (RDEB) is a rare connective tissue disorder 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 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.
