Adverum Biotechnologies Provides Update on the INFINITY Trial Evaluating ADVM-022 in Patients with Diabetic Macular Edema
April 28 2021 - 4:01PM
Adverum Biotechnologies, Inc. (Nasdaq: ADVM) announced a Suspected
Unexpected Serious Adverse Reaction (SUSAR) of hypotony
(clinically-relevant decrease in ocular pressure) in its INFINITY
clinical trial evaluating ADVM-022 gene therapy for the treatment
of diabetic macular edema (DME). This event occurred 30 weeks after
randomization in one patient treated with a single intravitreal
injection of the high dose (6 x 10^11 vg/eye) of ADVM-022 who has
developed hypotony, with panuveitis and loss of vision in the
treated eye.
In the interests of patient safety, Adverum has decided to
immediately unmask the INFINITY Phase 2 study to better understand
this event and to help identify and manage any similar potential
risk to other patients in this study, which completed patient
dosing in December 2020. Additionally, the company is conducting a
thorough review of data from the ADVM-022 program and plans to
report its findings as the analysis progresses.
“The safety of every patient who is participating in our
clinical studies with our gene therapy is the utmost priority for
us at Adverum,” said Laurent Fischer, M.D., chief executive officer
of Adverum. “We are fully committed to thoroughly assessing this
case and ongoing monitoring of this patient and all patients
treated with ADVM-022 with our investigators, data monitoring
committee (DMC), scientific advisory board, and healthcare
authorities.”
The INFINITY study is evaluating two doses of a single
intravitreal (IVT) injection of ADVM-022 gene therapy, either a
high dose 6 x 10^11 vg/eye or low dose 2 x 10^11 vg/eye. As of
December 2020, the INFINITY study was fully enrolled, and all
patients completed dosing of the single IVT injection of ADVM-022.
All patients continue to be evaluated regularly during the
monitoring phase of this study. Adverum is working closely with the
DMC and the study sites to proactively develop additional
recommendations for patient monitoring and management. All clinical
trial sites, as well as the U.S. Food and Drug Administration
(FDA), have been advised of this case.
About the INFINITY Phase 2 Trial of ADVM-022 in
DR/DMEINFINITY is a Phase 2, multi-center, randomized,
double-masked, active comparator-controlled trial designed to
assess a single intravitreal (IVT) injection of ADVM-022 in
patients with diabetic macular edema (DME), the most common cause
of vision loss in patients with diabetic retinopathy (DR).
The INFINITY trial enrolled 36 patients and is designed to
demonstrate superior control of disease activity following a single
IVT injection of ADVM-022 compared to a single aflibercept
injection, as measured by time to worsening of DME disease
activity. Participants in this double-masked trial were randomized
to one of three arms for their study eye treatment: Arm 1 received
high dose (6 x 10^11 vg/eye) of ADVM-022, Arm 2 received low dose
(2 x 10^11 vg/eye) of ADVM-022, and Arm 3 received aflibercept at a
dose of 2 mg. Additional objectives include assessments of
treatment burden, visual acuity, retinal anatomy, and safety
outcomes. For additional information about the INFINITY trial,
please visit www.clinicaltrials.gov using Identifier NCT#04418427
or www.INFINITYclinicaltrial.com.
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.
Actual results could differ materially from those anticipated in
such forward-looking statements as a result of various risks and
uncertainties, which include risks described in Adverum’s Quarterly
Report on Form 10-K for the year ended December 31, 2020 and any
subsequent filings with the SEC 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 Relations Contacts
Myesha Lacy
Adverum Biotechnologies, Inc.
T: 650-649-1257
E: mlacy@adverum.com
Amy Figueroa
Adverum Biotechnologies, Inc.
T: 650-823-2704
E: afigueroa@adverum.com
Media Contact
Andrea Cohen
Sam Brown Inc.
T: 917-209-7163
E: andreacohen@sambrown.com
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