AGTC to Present Three-Month Interim Results from the SKYLINE Clinical Trial of AGTC-501 for the Treatment of X-Linked Retinitis Pigmentosa at the 45th Macula Society Annual Meeting
June 06 2022 - 8:00AM
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 an encore presentation
of interim data from its ongoing Phase 2 Skyline trial of AGTC-501,
a recombinant AAV viral vector-based gene therapy targeting
mutations in the RPGR gene in patients with X-linked retinitis
pigmentosa (XLRP), at the 45th Macula Society Annual Meeting taking
place June 8-11, 2022, in Berlin, Germany.
“We are excited to share these data from the Skyline clinical
trial with the international ophthalmology community, as we believe
robust improvements in visual sensitivity, along with a favorable
safety profile, show great promise for AGTC-501 as a potential
treatment for patients with XLRP”, said Dr. Susan Schneider, Chief
Medical Officer of AGTC. “We look forward to sharing future updates
as we continue to progress AGTC-501 through the Vista Phase 2/3
clinical trial and towards a potential BLA submission.”
Presentation details are as follows:
Subretinal Gene Therapy Drug AGTC-501 for X-Linked
Retinitis Pigmentosa Phase 2 Randomized,
Controlled, Masked Multi-center Clinical Trial (Skyline) Interim
Efficacy ResultsPresenter: Andreas Lauer, MD, Chair,
Department of Ophthalmology, Casey Eye Institute - Oregon Health
& Science University Session Date/Time: June 8, 2022; 6:06-6:52
p.m. CET Presentation Date/Time: 6:06-6:15 p.m. CETLocation: The
Ritz-Carlton, Berlin, Main Room
Additional information can be found on the 45th Scientific
Program schedule.
About X-Linked Retinitis Pigmentosa (XLRP)
X-linked Retinitis Pigmentosa (XLRP) is an inherited condition
that causes progressive vision loss in boys and young men.
Characteristics of the disease include night blindness in early
childhood and progressive constriction of the visual field. In
general, XLRP patients experience a gradual decline in visual
acuity over the disease course, which results in legal blindness
around the 4th or 5th decade of life.
About AGTC
AGTC 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 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 interim results from the Skyline Trial in XLRP, the potential of
AGTC-501 as a treatment for XLRP, the ability to use the interim
Skyline results as a predictor of the success of the final Skyline
and Vista clinical trial results and whether these results will
support future regulatory filings for AGTC-501. 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, including but not limited to
XLRP, 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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