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Abeona Therapeutics Announces Additional Phase 3 VIITAL™ Study Results for EB-101 Presented at the International Societies for Investigative Dermatology 2023 Meeting
CLEVELAND, May 11, 2023 (GLOBE NEWSWIRE) -- Abeona Therapeutics Inc. (Nasdaq: ABEO) today announced an oral presentation of additional data from the Company's
About this update from Abeona Therapeutics Inc.
[{"type":"text","content":"CLEVELAND, May 11, 2023 (GLOBE NEWSWIRE) -- Abeona Therapeutics Inc. (Nasdaq: ABEO) today announced an oral presentation of additional data from the Company's pivotal Phase 3 VIITAL™ study evaluating its investigational EB-101 for recessive dystrophic epidermolysis bullosa (RDEB). The data presentation occurred earlier today during the inaugural International Societies for Investigative Dermatology (ISID) Meeting in Tokyo, Japan. “Following the positive topline VIITAL study results reported in November 2022, the additional data reported at ISID further highlights the value proposition of EB-101 by demonstrating improved wound healing and pain reduction at 6, 12 and 24 weeks compared to control wounds following a one-time application of EB-101,” said Vish Seshadri, Chief Executive Officer of Abeona. “Furthermore, EB-101 demonstrated improvement in patient-reported and caregiver-reported outcomes for itch severity and blistering. In totality, these results highlight the potential for EB-101 to meaningfully improve quality of life of RDEB patients.” Presentation HighlightsIn the presentation, entitled, “Results from VIITAL: A phase 3, randomized, intrapatient-controlled trial of an investigational collagen type VII gene–corrected autologous cell therapy, EB-101, for the treatment of recessive dystrophic epidermolysis bullosa (RDEB),” Jean Tang, M.D., Ph.D., Professor of Dermatology, Stanford University School of Medicine and Principal Investigator of the VIITAL study reported: Both co-primary endpoints of VIITAL were met, with the majority (81.4%) of randomized EB-101–treated wounds demonstrating ≥50% healing compared with 16.3% of untreated control wounds, and a significantly greater reduction in pain severity observed in randomized EB-101−treated wounds (3.07 mean pain reduction from baseline) compared with untreated control wounds (0.90 mean pain reduction from baseline) at six months.At earlier time points, meaning weeks 6 and 12, the percentage of wounds with ≥50%, ≥75%, and complete healing, as well as pain reduction, was greater for randomized EB-101–treated wounds and achieved statistical significance over untreated control wounds.In addition to significantly reducing pain, patient-reported outcomes related to itch and blistering showed significantly greater improvement with EB-101 treatment.Caregiver-reported outcomes rela...