Database lock for pivotal phase III VIITAL study of EB 101 in patients with recessive dystrophic epidermolysis bullosa
Abeona Therapeutics announced the database lock on October 18, 2022 for the pivotal Phase III VIITAL study of its investigational autologous, engineered cell therapy, EB 101, in patients with recessive dystrophic epidermolysis bullosa (RDEB)
With the database now locked, the Company remains on track to report topline results in the next two to three weeks, consistent with guidance provided in early-October. “I want to thank the clinical team at Abeona and our study sites Stanford and UMass for their collaborative effort and speed in achieving this milestone in about two weeks following completion of the last patient visit,” said Vish Seshadri, Chief Executive Officer of Abeona. Abeona expects the VIITAL study, if positive, to serve as a basis for seeking approval by the FDA of EB 101 for the treatment of patients with RDEB.