Adverum Biotechnologies Announces First Patient Randomized in Phase 2 INFINITY Trial of ADVM-022 Single Injection Gene Therapy for Diabetic Macular Edema (DME)
-- INFINITY trial is currently enrolling patients with DME, the most common cause of vision loss in people with diabetic retinopathy --
“We are excited to have randomized the first patient in INFINITY,” said
About the INFINITY Phase 2 Trial of ADVM-022 in DR/DME
INFINITY 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 will enroll approximately 33 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 activities. Additional objectives include assessments of treatment burden, visual acuity, retinal anatomy, and safety outcomes.
About Diabetic Retinopathy (DR) and Diabetic Macular Edema (DME)
Diabetic retinopathy (DR) affects approximately one in three adults with diabetes and can put patients at risk of vision loss. DR can be diagnosed at different severity levels, and is the most common cause of blindness in working-age adults in the
Diabetic macular edema (DME) is a vision-threatening complication of DR that can occur at any severity stage of
The current standard-of-care therapy for DME is anti-VEGF intravitreal injections. These are effective but typically require frequent and long-term injections for patients to maintain good vision. Compliance with these regimens can be difficult for patients, leading to undertreatment and vision loss. Real-world outcomes in DME with anti-VEGF therapy are meaningfully worse than in clinical trials.
About ADVM-022 Gene Therapy
ADVM-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
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.
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 as to its plans to advance ADVM-022 in DME by enrolling patients in the INFINITY trial, and as to the expected enrollment numbers for the trial; and Adverum’s expectations that it will present data from the INFINITY trial in the second half of 2021. 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.
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Source: Adverum Biotechnologies, Inc.