Abeona Therapeutics Announces Acceptance of Abstract on EB-101 Phase 3 VIITAL™ Study Results for Oral Presentation at International Societies for Investigative Dermatology (ISID) 2023 Meeting
Abeona Therapeutics Inc. (Nasdaq: ABEO) has announced that additional data from the Phase 3 VIITAL™ study of EB-101, targeting recessive dystrophic epidermolysis bullosa (RDEB), will be presented at the International Societies for Investigative Dermatology Meeting in Tokyo from May 10-13, 2023. The study's abstract, highlighting results from this trial, will be delivered by Dr. Jean Tang of Stanford University. EB-101 is an autologous gene therapy designed to correct the COL7A1 gene defect in RDEB patients, which currently has no approved treatment. EB-101 has received multiple designations from the U.S. FDA.
- EB-101 has demonstrated positive top-line efficacy and safety data in the Phase 3 VIITAL study.
- The upcoming presentation at a prestigious international conference may enhance visibility and interest in the treatment.
- No current approved treatment for RDEB could imply uncertainty about market potential.
- Risks associated with obtaining necessary regulatory approvals for EB-101.
NEW YORK and CLEVELAND, March 16, 2023 (GLOBE NEWSWIRE) -- Abeona Therapeutics Inc. (Nasdaq: ABEO) today announced that additional data from its pivotal Phase 3 VIITAL™ study of EB-101 for recessive dystrophic epidermolysis bullosa (RDEB) has been accepted for an oral presentation at the inaugural International Societies for Investigative Dermatology (ISID) Meeting, being held May 10-13, 2023 in Tokyo, Japan. Abeona previously reported positive top-line efficacy and safety data from the VIITAL study in November 2022.
Abstract number 806 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),” will be presented by Jean Tang, M.D., Ph.D., Professor of Dermatology, Stanford University School of Medicine and Principal Investigator of the VIITAL study during a session between 1:15-3:45 p.m. Japan Standard Time on May 11, 2023.
About Recessive Dystrophic Epidermolysis Bullosa
Recessive dystrophic epidermolysis bullosa (RDEB) is 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. People with RDEB have a defect in the COL7A1 gene, leaving them unable to produce functioning type VII collagen, which is necessary to anchor the dermal and epidermal layers of the skin. There is currently no approved treatment for RDEB.
About EB-101
EB-101 is an autologous, engineered cell therapy currently being developed for the treatment of recessive dystrophic epidermolysis bullosa (RDEB), a rare connective tissue disorder without an approved therapy. The pivotal Phase 3 VIITAL™ study is a randomized clinical trial that evaluated the efficacy, safety and tolerability of EB-101 in 43 large chronic wound pairs in 11 subjects with RDEB. Treatment with EB-101 involves using gene transfer to deliver the functional COL7A1 gene into a patient’s own skin cells (keratinocytes and its progenitors) and transplanting those cells back to the patient. EB-101 is being investigated for its ability to enable normal Type VII collagen expression and to facilitate wound healing. EB-101 has been granted Regenerative Medicine Advanced Therapy, Breakthrough Therapy, Orphan Drug and Rare Pediatric Disease designations by the U.S. FDA. Abeona produces EB-101 for the VIITAL study at its fully integrated gene and cell therapy manufacturing facility in Cleveland, Ohio. EB-101 is an investigational product not yet approved by the FDA.
About Abeona Therapeutics
Abeona Therapeutics Inc. is a clinical-stage biopharmaceutical company developing cell and gene therapies for serious diseases. Abeona’s lead clinical program is EB-101, its investigational autologous, engineered cell therapy currently in development for recessive dystrophic epidermolysis bullosa. The Company’s development portfolio also features AAV-based gene therapies for ophthalmic diseases with high unmet medical need. Abeona’s novel, next-generation AAV capsids are being evaluated to improve tropism profiles for a variety of devastating diseases. Abeona’s fully integrated cell and gene therapy cGMP manufacturing facility produces EB-101 for the pivotal Phase 3 VIITAL™ study and is capable of clinical and potential commercial production of AAV-based gene therapies. For more information, visit www.abeonatherapeutics.com.
Forward-Looking Statements
This press release contains certain statements that are forward-looking within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, and that involve risks and uncertainties. We have attempted to identify forward-looking statements by such terminology as “may,” “will,” “believe,” “anticipate,” “expect,” “intend,” and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances), which constitute and are intended to identify forward-looking statements. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, numerous risks and uncertainties, including but not limited to, our ability to continue as a going concern; the timing and outcome of our Biologics License Application submission to the FDA for EB-101; continued interest in our rare disease portfolio; our ability to enroll patients in clinical trials; the outcome of any future meetings with the FDA or other regulatory agencies; the ability to achieve or obtain necessary regulatory approvals; the impact of changes in the financial markets and global economic conditions; risks associated with data analysis and reporting; and other risks disclosed in the Company’s most recent Annual Report on Form 10-K and other periodic reports filed with the Securities and Exchange Commission. The Company undertakes no obligation to revise the forward-looking statements or to update them to reflect events or circumstances occurring after the date of this press release, whether as a result of new information, future developments or otherwise, except as required by the federal securities laws.
FAQ
What is the purpose of the Phase 3 VIITAL study for ABEO?
When will the results from the VIITAL study be presented?
What designations has EB-101 received from the FDA?
What is recessive dystrophic epidermolysis bullosa (RDEB)?
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