Adverum Biotechnologies Reports Continued Momentum with OPTIC Trial for ADVM-022 Intravitreal Gene Therapy in Wet AMD and Pr...
January 12 2020 - 6:00PM
Adverum Biotechnologies, Inc. (Nasdaq: ADVM), a clinical-stage gene
therapy company targeting unmet medical needs in ocular and rare
diseases, today reviewed recent business and development progress
and provided an outlook for 2020.
“In 2019, we made significant progress advancing our lead gene
therapy candidate ADVM-022 in the ongoing OPTIC phase 1
dose-ranging clinical trial in patients with wet age-related
macular degeneration (AMD),” said Leone Patterson, president and
chief executive officer of Adverum Biotechnologies. “Patients with
wet AMD typically require frequent ocular anti-VEGF injections to
maintain their vision. Yesterday, additional data were presented
from the first cohort of patients in OPTIC, which demonstrated zero
anti-VEGF rescue injections required following a single
intravitreal injection of ADVM-022 and with median follow up of 44
weeks, ADVM-022 treatment was safe and well-tolerated. This year,
we look forward to presenting additional data from all four cohorts
of patients in OPTIC. Additionally, we plan to submit an IND for
ADVM-022 in a second indication, diabetic retinopathy, and begin
enrolling patients in a new clinical trial. We believe ADVM-022 has
the potential to be a paradigm-changing treatment for patients with
wet AMD and for patients with diabetic retinopathy.”
Recent Data Presented for First Cohort of OPTIC Phase 1
Clinical Trial (n=6)On January 11, 2020, Adverum presented
median 44-week (range of 40-52 weeks) data at the Atlantic Coast
Retina Club and Macula 20/20. These data demonstrated that patients
in the first cohort of OPTIC achieved vision maintenance and
improvements in retinal anatomy with zero anti-VEGF rescue
injections required for any patient. Additionally, the first
patient treated in OPTIC has reached 52 weeks post ADVM-022
administration. ADVM-022 has been safe and well-tolerated, with no
dose-limiting toxicities through the latest time point at December
1, 2019 and inflammation has been manageable with topical eye
drops.
OPTIC Phase 1 Trial ExecutionAfter completing
patient enrollment in the first and second cohorts, Adverum dosed
the first patient in the third cohort (n=9, dose of 2x10^11 vg/eye)
in October 2019. In the third and fourth cohorts, Adverum plans to
use prophylactic steroid eye drops instead of prophylactic oral
steroids to manage inflammation.
2020 Outlook
First quarter of 2020:
- Move to new corporate headquarters in Redwood City, CA,
allowing for the expansion of the company’s in-house process
development capabilities to the 1,000-liter production scale
- Complete patient dosing in the third cohort, begin enrollment
in the fourth cohort, and determine if additional cohorts are
needed in the OPTIC trial
First half of 2020:
- Present longer-term data from the first cohort of patients in
OPTIC
- Present 24-week data from the second cohort of patients in
OPTIC
- Submit an investigational new drug application for ADVM-022 in
diabetic retinopathy, a key VEGF-driven cause of vision loss among
working-age adults
Second half of 2020:
- Present longer-term data from the first cohort and second
cohorts of patients in OPTIC trial
- Present clinical data from the third and fourth cohorts of
patients in the OPTIC trial
- Begin enrolling patients in a planned phase 1/2 clinical trial
for ADVM-022 in diabetic retinopathy to expand Adverum’s clinical
development pipeline
Upcoming EventsAdverum plans to participate in
the following upcoming conferences:
- J.P. Morgan’s 38th Annual Healthcare Conference in San
Francisco on January 15, 2020 at 2:30 pm PST
- Angiogenesis, Exudation, and Degeneration 2020 in Miami on
February 8, 2020 at 2:44 pm EST. Dr. David Boyer will present the
24-week data from the second cohort for the first time as well as
an update from the first cohort of patients in the OPTIC trial. A
KOL event and simultaneous webcast to discuss the data presented
with management and an expert panel of retina specialists will take
place on February 9, 2020 at 10:00 am EST
- SVB Leerink’s 9th Annual Global Healthcare Conference in New
York on February 25, 2020 at 9 am EST
- Cowen’s 40th Annual Health Care Conference in Boston from March
2-4, 2020
About Adverum Biotechnologies, Inc.Adverum
Biotechnologies (Nasdaq: ADVM) is a clinical-stage gene therapy
company targeting unmet medical needs for serious ocular and rare
diseases. Adverum is evaluating its novel gene therapy candidate,
ADVM-022, as a one-time, intravitreal injection for the treatment
of its lead indication, wet age-related macular degeneration. For
more information, please visit www.adverum.com.
Forward-looking StatementsStatements 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:
Adverum’s plans to report additional clinical data for ADVM-022
from the OPTIC trial and to advance ADVM-022, including Adverum’s
plans to submit an Investigational New Drug Application for
ADVM-022 for the treatment of diabetic retinopathy to the U.S. Food
and Drug Administration in the first half of 2020, and the
potential benefits of ADVM-022, all of which are based on certain
assumptions made by Adverum on current conditions, expected future
developments and other factors Adverum believes are appropriate in
the circumstances. Adverum may not achieve any of these in a timely
manner, or at all, or otherwise carry out the intentions or meet
the expectations disclosed in its forward-looking statements, and
you should not place undue reliance on these forward-looking
statements. Actual results and the timing of events 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
trial and vector production; and ability to fund operations through
completion of the OPTIC trial and thereafter. Risks and
uncertainties facing Adverum are described more fully in Adverum’s
Form 10-Q filed with the SEC on November 7, 2019 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
Biotechnologiesmlacy@adverum.com 1-650-304-3892
Media:Cherilyn Cecchini, M.D.LifeSci
Communicationsccecchini@lifescicomms.com1-646-876-5196
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