Abeona Therapeutics Inc. announced that target enrollment has been achieved in its pivotal Phase 3 VIITAL™ study. The objective of VIITAL™ is to evaluate the safety and effectiveness of Abeona's investigational EB-101 product for the treatment of recessive dystrophic epidermolysis bullosa (RDEB), 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. Large chronic wounds typically do not heal spontaneously and inflict the great pain and clinical burden on RDEB patients.

Large chronic wounds treated in VIITAL™ measured greater than 20 cm2 of surface area and had remained open for more than six months. In a phase 1/2a study conducted at Stanford University, large chronic wounds treated with EB-101 showed considerable wound healing and reduction in associated long-term pain for up to six years. The EB-101 pivotal VIITAL™ study treated patients at Stanford University Medical Center in Palo Alto, CA and at UMass Memorial Medical Center in Worcester, MA and met the goal of randomizing a minimum of 36 wound pairs (i.e., each pair has a treated and untreated wound) in a minimum of 10 patients.

The co-primary endpoints of the study are: 1) the proportion of randomized RDEB wound pairs with greater than or equal to 50% healing from baseline at Week 24 (Month 6), as determined by direct investigator assessment; and 2) pain reduction associated with wound dressing change assessed by the mean differences in scores of the Wong-Baker FACES scale between randomized wound pairs at Week 24 (Month 6). Given that the primary endpoint is measured at 24 weeks post treatment, the Company anticipates topline results in the third quarter of 2022.