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Abeona Therapeutics Announces Publication of Positive Long-Term Data from Phase 1/2a Clinical Trial Evaluating EB-101 Gene Therapy for Recessive Dystrophic Epidermolysis Bullosa
Sustained wound healing and favorable safety profile observed at three years post-treatment Durable wound healing in large, disabling, chronic wounds EB-101
About this update from Abeona Therapeutics Inc.
[{"type":"text","content":"Sustained wound healing and favorable safety profile observed at three years post-treatment\n Durable wound healing in large, disabling, chronic wounds EB-101 associated with long-term molecular expression of Type VII collagen protein NEW YORK and CLEVELAND, Oct. 15, 2019 (GLOBE NEWSWIRE) -- Abeona Therapeutics Inc. (Nasdaq: ABEO), a fully-integrated leader in gene and cell therapy, today announced positive long term efficacy and safety results from its Phase 1/2a clinical trial evaluating EB-101, a gene-corrected cell therapy for recessive dystrophic epidermolysis bullosa (RDEB). Treatment with EB-101 resulted in sustained wound healing with a favorable safety profile at three years post-treatment. These long-term follow-up data in seven RDEB participants with 42 treated wounds were published in the peer-reviewed journal JCI Insight. Full text of the publication can be accessed here: https://insight.jci.org/articles/view/130554 “These results bolster our belief that EB-101 is a safe and effective gene-corrected cell therapy capable of providing durable, long-lasting healing for the most disabling wounds in patients with RDEB,” said João Siffert, M.D., Chief Executive Officer of Abeona. “These results are particularly significant, as EB-101 treatment led to wound healing even in the most challenging to treat large and painful chronic wounds. Given the average RDEB chronic wound size is over 118 cm2, it is essential that potential new treatments are capable of addressing these wounds to improve quality of life. We thank our collaborators at Stanford and the patients who volunteered to participate in this study and look forward to building upon this strong clinical foundation with the initiation of the pivotal Phase 3 VIITALTM Study evaluating EB-101 for the treatment of RDEB.” Key Study findings include: Wounds selected for treatment were present for a mean of 11.2 years (range 3-20 years) Three years after treatment with EB-101, a majority of RDEB patients had sustained wound healing, with 80% (16/20) of wounds achieving ³50% healing, and 70% (14/20) achieving ≥75% Two years after treatment, only 1 of 6 untreated (17%), prospectively selected control wounds, had ≥50% healing 50% or greater wound healing was associated with no pain (0/16) and no itch (0/16) at treated sites three years post-treatment, compared with presence of pa...