Adverum Biotechnologies Announces Completion of Patient Dosing in Cohort 4 of the OPTIC Phase 1 Trial of ADVM-022 Single Inje...
July 06 2020 - 9:00AM
Adverum Biotechnologies, Inc. (Nasdaq: ADVM), a clinical-stage gene
therapy company targeting unmet medical needs in ocular and rare
diseases, today announced the completion of patient dosing in
Cohort 4 of OPTIC, a Phase 1 clinical trial, assessing a single
intravitreal (IVT) injection of ADVM-022 in patients with wet
age-related macular degeneration (AMD). Wet AMD is a leading cause
of vision loss in patients over 60 years of age, with a prevalence
of approximately 1.2 million individuals in the U.S. and 3 million
worldwide.
“The excitement in the retina community around the OPTIC
clinical trial and the ADVM-022 program continues to grow,” said
Aaron Osborne, MBBS, chief medical officer of Adverum
Biotechnologies. “We look forward to presenting data from all four
cohorts by the end of this year. Our goal is to deliver a novel
one-time intravitreal treatment to patients living with wet AMD as
quickly as possible.”
David S. Boyer, M.D., senior partner, Retina-Vitreous Associates
Medical Group and adjunct clinical professor of ophthalmology with
the University of Southern California/Keck School of Medicine in
Los Angeles, California and investigator in OPTIC added, “Patients
enrolled in the OPTIC study have previously required frequent and
ongoing anti-VEGF injections to avoid losing vision. The long-term
durability beyond 1 year seen with a single intravitreal injection
of ADVM-022 in Cohort 1 is unprecedented. ADVM-022 has the
potential to transform the treatment paradigm and improve
real-world vision outcomes for patients with wet AMD.”
About the OPTIC Phase 1 Trial of ADVM-022 in Wet
AMDThis multi-center, open-label, Phase 1, dose-ranging
trial is designed to assess the safety and tolerability of a single
intravitreal (IVT) administration of ADVM-022 in patients with wet
AMD who are responsive to anti-vascular endothelial growth factor
(VEGF) treatment. In Cohort 1 (n=6) and Cohort 4 (n=9), patients
received ADVM-022 at the high dose of 6 x 1011 vg/eye. In Cohort 2
(n=6) and Cohort 3 (n=9), patients received ADVM-022 at the low
dose of 2 x 1011 vg/eye. Patients in Cohorts 3 and 4 received six
weeks of prophylactic steroid eye drops rather than 13 days of oral
steroids which were used in Cohorts 1 and 2. The primary endpoint
of the trial is the safety and tolerability of ADVM-022 after a
single IVT administration. Secondary endpoints include changes in
best-corrected visual acuity (BCVA), measurement of central retinal
thickness (CRT), as well as the need for anti-VEGF rescue
injections. Each patient enrolled will be followed for a total of
two years.
Eleven leading retinal centers across the United
States (U.S.) are participating in the OPTIC Phase 1 trial for
ADVM-022. For more information on the OPTIC Phase 1 clinical trial
of ADVM-022 in wet AMD, please
visit https://clinicaltrials.gov/ct2/show/NCT03748784.
About ADVM-022 Gene TherapyADVM-022 utilizes a
proprietary vector capsid, AAV.7m8, carrying an aflibercept coding
sequence under the control of a proprietary expression cassette.
ADVM-022 is administered as a one-time intravitreal injection
(IVT), designed to deliver long-term efficacy and reduce the burden
of frequent anti-VEGF injections, optimize patient compliance and
improve vision outcomes for patients with wet age-related macular
degeneration (wet AMD) and diabetic macular edema (DME).
In recognition of the need for new treatment options for wet
AMD, the U.S. Food and Drug Administration granted Fast Track
designation for ADVM-022 for the treatment of wet AMD. Adverum is
currently evaluating ADVM-022 in the OPTIC Phase 1 clinical trial
in patients with wet AMD and the INFINITY Phase 2 trial in patients
with DME.
About Wet Age-related Macular Degeneration
(AMD)Age-related macular degeneration (AMD) is a
progressive disease affecting the macula, the region of the retina
at the back of the eye responsible for central vision. In patients
with wet AMD, an aggressive form of AMD, abnormal blood vessels
grow underneath and into the retina. These abnormal blood vessels
leak fluid and blood into and beneath the retina, causing vision
loss.
Wet AMD is a leading cause of vision loss in patients over 60
years of age, with a prevalence of approximately 1.2 million
individuals in the U.S. and 3 million worldwide. The incidence of
new cases of wet AMD in the U.S. is approximately 150,000 to
200,000 annually, and this number is expected to grow significantly
as the country’s population ages.
The current standard-of-care therapy for wet AMD is anti-VEGF
intravitreal injections. These are effective but typically require
eye injections every 4-12 weeks in order to maintain vision.
Compliance with this regimen can be difficult for patients,
caregivers, and healthcare systems, leading to undertreatment and
resulting in loss of vision.
About Adverum BiotechnologiesAdverum
Biotechnologies (Nasdaq: ADVM) is a clinical-stage gene therapy
company targeting unmet medical needs in serious ocular and rare
diseases. Adverum is advancing the clinical development of its
novel gene therapy candidate, ADVM-022, as a one-time, intravitreal
injection for the treatment of patients with wet age-related
macular degeneration and diabetic macular edema. For more
information, please visit www.adverum.com.
Forward-looking Statements Statements contained
in this press release regarding the events or results that may
occur in the future are “forward-looking statements” within the
meaning of the Private Securities Litigation Reform Act of 1995.
Such statements include but are not limited to statements
regarding: the potential for ADVM-022 in treating patients with wet
AMD and DME; and Adverum’s expectations that it will present data
from all four cohorts of the OPTIC Phase 1 trial for ADVM-022 in
wet AMD by the end of this year. Actual results could differ
materially from those anticipated in such forward-looking
statements as a result of various risks and uncertainties, which
include risks inherent to, without limitation: Adverum’s novel
technology, which makes it difficult to predict the time and cost
of product candidate development and obtaining regulatory approval;
the results of early clinical trials not always being predictive of
future results; the potential for future complications or side
effects in connection with use of ADVM-022; obtaining regulatory
approval for gene therapy product candidates; enrolling patients in
clinical trials; reliance on third parties for conducting the OPTIC
and INFINITY trials and vector production; the effects of the
COVID-19 pandemic on the company’s operations and on the company’s
ongoing clinical trials; and ability to fund operations through
completion of the OPTIC and INFINITY trials and thereafter. Risks
and uncertainties facing Adverum are described more fully in
Adverum’s Form 10-Q filed with the SEC on May 28,
2020 under the heading “Risk Factors.” All forward-looking
statements contained in this press release speak only as of the
date on which they were made. Adverum undertakes no obligation to
update such statements to reflect events that occur or
circumstances that exist after the date on which they were
made.
Investor and Media Inquiries:
Investors:Myesha LacyAdverum Biotechnologies,
Inc.mlacy@adverum.com1-650-304-3892
Media:Cherilyn Cecchini, M.D.LifeSci
Communicationsccecchini@lifescicomms.com1-646-876-5196
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