Abeona Therapeutics Announces Completion of Patient Follow-up in Pivotal Phase 3 VIITAL™ Study of EB-101 in Patients with Recessive Dystrophic Epidermolysis Bullosa (RDEB)
October 04 2022 - 6:30AM
Abeona Therapeutics Inc. (Nasdaq: ABEO) today announced that the
last patient has completed their 6-month follow-up visit in
Abeona’s pivotal Phase 3 VIITAL™ study of its investigational
autologous, engineered cell therapy, EB-101, in patients with
recessive dystrophic epidermolysis bullosa (RDEB).
“Completion of the last patient’s 6-month
follow-up visit marks a key milestone that enables us to report key
findings from our Phase 3 VIITAL™ study of EB-101 in RDEB,” said
Vish Seshadri, Chief Executive Officer of Abeona. “We thank the
patients, their families, and the clinical investigators, and plan
to report topline results from this pivotal study within the next
month.”
Abeona has been verifying and preparing the data
in real time to ensure that an efficient database lock can be
completed within two to three weeks from the last patient’s final
visit. Abeona expects the VIITAL™ study, if positive, to serve as
the basis for seeking approval by the U.S. Food and Drug
Administration (FDA) of EB-101 for the treatment of patients with
RDEB.
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 investigated in
Abeona’s pivotal Phase 3 VIITAL™ study for the treatment of
recessive dystrophic epidermolysis bullosa (RDEB), a rare
connective tissue disorder without an approved therapy. The EB-101
VIITAL™ study is a randomized clinical trial with target enrollment
of at least 10 to 15 RDEB patients with approximately 36 large,
chronic wound sites treated in total. Treatment with EB-101
involves using gene transfer to deliver the 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. The U.S. FDA has
granted Rare Pediatric Disease Designation for EB-101. 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 for recessive dystrophic
epidermolysis bullosa is in Phase 3 development. 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 StatementsThis
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,” “plan to,” “expect,” 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 report topline results from our Phase 3
VIITAL™ study and the timing thereof, our ability to continue as a
going concern;; the outcome of any future meetings with the U.S.
Food and Drug Administration or other regulatory agencies; the
ability to achieve or obtain necessary regulatory approvals; and
other risks disclosed in the Company’s most recent Annual Report on
Form 10-K and subsequent 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.
Investor and Media Contact:
Greg Gin
VP, Investor Relations and Corporate Communications
Abeona Therapeutics
ir@abeonatherapeutics.com
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