AGTC to Showcase Interim Findings from Ongoing XLRP and Achromatopsia Phase 1/2 Trials at the Association for Research in Vision and Ophthalmology 2022 Annual Meeting
April 04 2022 - 3:45PM
Applied Genetic Technologies Corporation (Nasdaq: AGTC), a
clinical stage biotechnology company focused on the development of
adeno-associated virus (AAV)-based gene therapies for the treatment
of rare and debilitating diseases with an initial focus on
inherited retinal diseases, today announced multiple presentations
related to the Company’s ongoing clinical trials in X-linked
retinitis pigmentosa (XLRP) and achromatopsia (ACHM) at the
Association for Research in Vision and Ophthalmology’s 2022 Annual
Meeting (ARVO 2022), taking place May 1 – 4, 2022 in Denver,
Colorado. The presentations will be available virtually on May 11 –
12, 2022.
“We are excited to share these interim results from our ongoing
gene therapy trials with members of the ophthalmology community,”
said Dr. Susan Schneider, Chief Medical Officer of AGTC. “Over the
past year, we have continued to validate the potential of our gene
therapy platform with interim results from multiple clinical trials
in XLRP and ACHM. We anticipate that these findings will add to the
growing body of evidence supporting our investigational treatments
for those with rare inherited retinal diseases.”
AGTC presentations at ARVO 2022:
Findings on Visual Photosensitivity in Two Phase 1/2
Clinical Trials of Subretinal Gene Therapy with AGTC-401 and
AGTC-402 for CNGB3 and CNGA3 ACHM (paper)Presenter: Rachel
Huckfeldt, M.D., Ph.D., Assistant Professor of Ophthalmology at
Harvard Medical School Session Date/Time: May 1, 2022; 2:45 – 4:45
p.m. MDTPresentation Date/Time: 2:45 – 3:02 p.m. MDTLocation: Four
Seasons Ballroom 1
Interim Safety Results in Two Phase 1/2 Open-label,
Dose-escalation Clinical Trials of Subretinal Gene Therapy with
AGTC-401 and AGTC-402 in Subjects with Achromatopsia
(ACHM) (poster)Presenter: Alessandro Iannaccone, MD, MS,
Professor of Ophthalmology and Director of the Center for Retinal
Degenerations and Ophthalmic Genetic Diseases at Duke University
School of MedicinePoster Session Date/Time: May 3, 2022; 1 – 3
p.m.MDT
18-Month Analysis of Macular Structure Using Optical
Coherence Tomography (OCT) from a Phase 1/2 Clinical Study of
Subretinal Gene Therapy Drug AGTC-501 for X-Linked Retinitis
Pigmentosa (XLRP) (poster)Presenter: Paul Yang, MD, PhD,
Assistant Professor of Ophthalmology at the Casey Eye Institute,
Oregon Health & Science University in PortlandPoster Session
Date/Time: May 4, 2022; at 3 – 5 p.m.MDT.
About AGTCAGTC is a clinical-stage
biotechnology company developing genetic therapies for people with
rare and debilitating ophthalmic, otologic and central nervous
system (CNS) diseases. AGTC is a leader in designing and
constructing all critical gene therapy elements and bringing them
together to develop customized therapies with the potential to
address unmet patient needs. AGTC’s most advanced clinical programs
leverage its best-in-class technology platform to potentially
improve vision for patients with inherited retinal diseases. AGTC
has active clinical trials in X-linked retinitis pigmentosa (XLRP)
and achromatopsia (ACHM CNGB3). Its preclinical programs build on
the company’s industry leading AAV manufacturing technology and
scientific expertise. AGTC is advancing multiple important pipeline
candidates to address substantial unmet clinical needs in
optogenetics, otology and CNS disorders, and has entered strategic
collaborations with companies including Bionic Sight, an innovator
in the emerging field of optogenetics, and retinal coding and
Otonomy, Inc., a biopharmaceutical company dedicated to the
development of innovative therapeutics for neurotology. For more
information, please visit https://agtc.com/.
Forward-Looking Statements This release
contains forward-looking statements that reflect AGTC's plans,
estimates, assumptions and beliefs, including statements about the
potential of the company’s gene therapy platform and the strength
of the expected interim results from multiple clinical trials in
XLRP and ACHM and whether these results will support future
regulatory filings. Forward-looking statements include all
statements that are not historical facts and can be identified by
terms such as "anticipates," "believes," "could," "seeks,"
"estimates," "expects," "intends," "may," "plans," "potential,"
"predicts," "projects," "should," "will," "would" or similar
expressions and the negatives of those terms. Actual results could
differ materially from those discussed in the forward-looking
statements, due to a number of important factors. Risks
and uncertainties that may cause actual results to differ
materially include, among others: gene therapy is still novel with
only a few approved treatments so far; AGTC cannot predict when or
if it will obtain regulatory approval to commercialize a product
candidate or receive reasonable reimbursement; uncertainty inherent
in clinical trials and the regulatory review process; risks and
uncertainties associated with drug development and
commercialization; risks and uncertainties related to funding
sources for our development programs; the direct and indirect
impacts of the ongoing COVID-19 pandemic on the Company’s business,
results of operations, and financial condition; factors that could
cause actual results to differ materially from those described in
the forward-looking statements are set forth under the heading
"Risk Factors" in the company’s most recent annual report on Form
10-K, as it may be supplemented by subsequent periodic reports
filed with the SEC. Given these uncertainties, you should not
place undue reliance on these forward-looking statements. Also,
forward-looking statements represent management's plans, estimates,
assumptions and beliefs only as of the date of this release. Except
as required by law, we assume no obligation to update these
forward-looking statements publicly or to update the reasons actual
results could differ materially from those anticipated in these
forward-looking statements, even if new information becomes
available in the future.
PR Contact:
Kerry Sinclair
Spectrum Science Communications
ksinclair@spectrumscience.com
Corporate Contact:
Jonathan Lieber
Chief Financial Officer
Applied Genetic Technologies Corporation
T: (617) 843-5778
jlieber@agtc.com
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