Adverum Biotechnologies, Inc. (Nasdaq: ADVM), a clinical-stage
company that aims to establish gene therapy as a new standard of
care for highly prevalent ocular diseases, today announced new
analyses from the OPTIC study treating wet age-related macular
degeneration (wet AMD) during the Late Breaking Developments
portion of Retinal Subspecialty Day at the American Academy of
Ophthalmology (AAO) 2022 Annual Meeting in Chicago, Illinois. New
data presented include the effects of ixoberogene soroparvovec
(Ixo-vec, formerly referred to as ADVM-022) on control of IRF and
SRF after a single, in-office, intravitreal (IVT) injection in
subjects requiring frequent anti-VEGF injections for their wet AMD.
“We are pleased to see Ixo-vec’s effects on reducing
intraretinal and subretinal fluid in treatment experienced patients
in our post-hoc analysis of data generated from the OPTIC trial,”
commented Richard Beckman, M.D., chief medical officer of Adverum
Biotechnologies. “These data suggest that continuous and consistent
expression of aflibercept has a stabilizing effect on the volume of
both intraretinal and subretinal fluid, something that bodes well
long-term. The connection between fluid fluctuations and long-term
visual acuity is the subject of active research and several studies
have demonstrated that less fluid fluctuation is associated with
better visual outcomes.”
Data Highlights
- Following a single IVT injection of a 2E11 dose of Ixo-vec in
OPTIC (n=15), there was a 93% and 55% reduction in mean IRF and SRF
volume, respectively, from baseline to Week 48.
- The percentage of subjects with dry SRF, across both the 6E11
and 2E11 dose groups, increased through Week 48 with a 200%
increase in the 2E11 dose group (n=15).
- Importantly, 60% of OPTIC participants receiving the 2E11 dose
had dry IRF at Week 48, representing a 50% increase from
baseline.
“The meaningful drying of intraretinal fluid and subretinal
fluid, as well as reduced exudative volatility observed in OPTIC is
highly promising, as we have started to appreciate the relationship
between these anatomical outcomes and the potential role on
preservation of vision long term in patients with wet AMD,” stated
Justis P. Ehlers, M.D., who led the advanced optical coherence
tomography analysis. “In addition, the increase in percentage of
OPTIC patients achieving complete fluid resolution over time,
through Week 48, at the 2E11 dose further reinforces the potential
benefits of a single IVT injection of Ixo-vec.”
Patient enrollment and dosing are currently underway in LUNA, a
double-masked, randomized, Phase 2 trial. Adverum expects to
conduct the trial at approximately 40 sites in the U.S. and Europe.
LUNA will evaluate Ixo-vec in subjects with wet AMD who are 50
years or older and have demonstrated a response to anti-VEGF
treatment. Up to 72 subjects will be randomized equally between the
2E11 dose and new lower 6E10 dose and across four prophylactic
steroid regimens. Specific regimens being evaluated include topical
difluprednate (Durezol®), IVT dexamethasone (Ozurdex®), or a
combination of either topical Durezol® or IVT Ozurdex® with oral
prednisone, with the aim of establishing a prophylactic regimen
with minimal need for inflammation management post prophylaxis.
“The important learnings from the OPTIC trial, such as the
association between anatomical improvements and the maintenance of
vision and long-term durability, were particularly encouraging,
especially as a physician who sees wet AMD patients on a daily
basis,” said Dante Pieramici, M.D., partner, California Retinal
Consultants, OPTIC investigator, and presenter of the data at AAO.
“I am excited to serve as an investigator in Adverum’s LUNA trial,
and provide my wet AMD patients with a single, in-office IVT
injection that can potentially serve as a functional cure to this
debilitating disease.”
About Wet Age-Related Macular Degeneration
Wet AMD, also known as neovascular AMD or nAMD, is an advanced
form of AMD, affecting approximately 10% of patients living with
AMD. Wet AMD is a leading cause of blindness in patients over 65
years of age, with a prevalence of approximately 20 million
individuals worldwide living with this condition. The incidence of
new cases of wet AMD is expected to grow significantly worldwide as
populations age. AMD is expected to impact 288 million people
worldwide by 2040, with wet AMD accounting for approximately 10% of
those cases.
About LUNA Trial of Ixo-Vec in Wet AMD
Ixoberogene soroparvovec (Ixo-vec) is Adverum’s clinical-stage
gene therapy product candidate being developed for the treatment of
wet AMD. Ixo-vec utilizes a proprietary vector capsid, AAV.7m8,
carrying an aflibercept coding sequence under the control of a
proprietary expression cassette. Unlike other ophthalmic gene
therapies that require surgery to administer the gene therapy under
the retina (sub-retinal approach), Ixo-vec is designed to be
administered as a one-time IVT injection in the office, deliver
long-term efficacy, reduce the burden of frequent anti-vascular
endothelial growth factor (VEGF) injections, optimize patient
compliance, and improve vision outcomes for patients with wet AMD.
Ixo-vec received PRIME designation from the European Medicines
Agency in June 2022.
The LUNA trial is a multicenter, double-masked, randomized,
parallel-group Phase 2 study evaluating two doses of Ixo-vec, the
2x10^11 vg/eye dose and a new, lower 6x10^10 vg/eye dose, in wet
AMD. The trial is designed to randomize up to 72 participants
equally across two doses and four prophylactic steroid regimens in
approximately 40 sites in the U.S. and Europe.
About Adverum Biotechnologies
Adverum Biotechnologies (NASDAQ: ADVM) is a clinical-stage
company that aims to establish gene therapy as a new standard of
care for highly prevalent ocular diseases with the aspiration of
developing functional cures to restore vision and prevent
blindness. Leveraging the research capabilities of its proprietary,
intravitreal (IVT) platform, Adverum is developing durable,
single-administration therapies, designed to be delivered in
physicians’ offices, to eliminate the need for frequent ocular
injections to treat these diseases. Adverum is evaluating its novel
gene therapy candidate, ixoberogene soroparvovec (Ixo-vec, formerly
referred to as ADVM-022), as a one-time, IVT injection for patients
with neovascular or wet age-related macular degeneration. By
overcoming the challenges associated with current treatment
paradigms for these debilitating ocular diseases, Adverum aspires
to transform the standard of care, preserve vision, and create a
profound societal impact around the globe. For more information,
please visit www.adverum.com.
Forward-looking Statements
Statements contained in this press release regarding 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 benefits of Ixo-vec and the
timing of preliminary data from the LUNA trial evaluating the same.
Actual results could differ materially from those anticipated in
such forward-looking statements as a result of various risks and
uncertainties, including risks inherent to, without limitation:
Adverum’s novel technology, which makes it difficult to predict the
timing of commencement and completion of clinical trials;
regulatory uncertainties; enrollment uncertainties; the results of
early clinical trials not always being predictive of future
clinical trials and results; and the potential for future
complications or side effects in connection with use of Ixo-vec.
Additional risks and uncertainties facing Adverum are set forth
under the caption “Risk Factors” and elsewhere in Adverum’s
Securities and Exchange Commission (SEC) filings and reports,
including Adverum’s Quarterly Report on Form 10-Q for the quarter
ended June 30, 2022 filed with the SEC on August 11, 2022. 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.
Corporate & Investor Inquiries
Anand ReddiVice President, Head of Corporate Strategy, External
Affairs and EngagementAdverum Biotechnologies, Inc.T:
650-649-1358E: areddi@adverum.com
Media
Megan TalonAssociate Director, Corporate CommunicationsAdverum
Biotechnologies, Inc.T: 650-649-1006E: mtalon@adverum.com
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