Co-primary endpoint measuring >50% wound healing, other endpoints measuring >75% and complete wound healing at six months all met
Co-primary endpoint measuring pain reduction at six months met; greater magnitude of pain reduction benefit was observed in post-hoc analysis of EB-101 treated wounds with severe baseline pain
EB-101 was well-tolerated with no serious treatment-related adverse events, consistent with past clinical experience
Plans to submit Biologics License Application (BLA) to U.S. FDA
Conference call on November 3, 2022 at 8:30 a.m. EDT
NEW YORK and CLEVELAND, Nov. 03, 2022 (GLOBE NEWSWIRE) — Abeona Therapeutics Inc. (NASDAQ:ABEO) today announced positive topline data from its pivotal Phase 3 VIITAL study assessing the safety and efficacy of EB-101 for the treatment of patients with recessive dystrophic epidermolysis bullosa (RDEB). The VIITAL study met its two co-primary efficacy endpoints demonstrating statistically significant, clinically meaningful improvements in wound healing and pain reduction in large chronic RDEB wounds.
“We are very pleased with the topline results from our pivotal VIITAL study, which reinforce the strong value proposition of EB-101 as a potential one-time therapy to both significantly improve wound healing and reduce pain for the most disabling, challenging to treat wounds in patients with RDEB,” said Vish Seshadri, Chief Executive Officer of Abeona. “The VIITAL study is differentiated from any other pivotal study in RDEB by the co-primary endpoint measuring patient-reported pain. We believe the significant result in this endpoint supports EB-101’s potential for improving the daily life of RDEB patients. Based on the efficacy and safety profile of EB-101 in VIITAL, we are looking forward to sharing the VIITAL study results with the FDA and progressing toward submission of a BLA. We are grateful to the patients, their families, caregivers, and the patient advocacy groups for their support of this study, and are also thankful for the clinical investigators, study site personnel, and the entire Abeona team who collectively contributed to this milestone achievement.”
