– Finalizing Two-Dose Study Design for Phase 2 Trial of ADVM-022 in Wet AMD
with Intention to Dose First Patient in Q32022 –
– Anticipates Near-term Hires to Further Strengthen Executive Team –
– Board of Directors is Actively Pursuing the Addition of Two New Directors –
– Expects Cash Position to Fund Development Plans and Operations into 2024 –
REDWOOD CITY, Calif., Dec. 21, 2021 (GLOBE NEWSWIRE) — 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 a review of its ADVM-022 program, outlined plans for the next stage of development in wet age-related macular degeneration (wet AMD) and provided anticipated key milestones for 2022.
Dr. Laurent Fischer, M.D., president and chief executive officer at Adverum Biotechnologies, stated: “We are pleased to conclude a thorough review of the totality of data generated in all 55 patients treated with ADVM-022, in wet AMD and diabetic macular edema, some of whom have been followed for over 2.5 years. The data analysis confirms our strategy to advance development of ADVM-022 in wet AMD. We intend to conduct a Phase 2 trial of ADVM-022 in wet AMD at 2 X 10^11 vg/eye dose and a new lower 6 X 10^10 vg/eye dose, with three new enhanced steroid prophylaxis regimens including topical, intravitreal and a combination of systemic and local steroids. Based on learnings from the OPTIC and INFINITY trials and extensive preclinical datasets, as well as the input and support of experts and members of our Scientific Advisory Board, we are confident in the plans we are sharing today to safely develop ADVM-022 in wet AMD, realizing the promise and full potential of our innovative gene therapy.”
Dr. Fischer continued, “I believe we have the right plan in place to establish the benefits and safety of ADVM-022 and progress our development pipeline. We have focused our capital on our development strategy prudently, with adequate financial resources in hand to complete the planned Phase 2 study, and I very much look forward to providing an update on our progress in 2022.”
Future Development of ADVM-022 for Wet AMD:
Phase 2 Trial Design. Subject to regulatory review, Adverum is finalizing the design for a Phase 2 trial of ADVM-022 in wet AMD investigating the 2 X 10^11 (2E11) vg/eye dose and a lower 6 X 10^10 vg/eye (6E10) vg/eye dose, with three new enhanced steroid prophylaxis regimens, which the company anticipates will include a topical, intravitreal (IVT) and a combination of systemic and local steroids. The trial is expected to enroll approximately 72 patients and evaluate similar endpoints to the Phase 1 OPTIC trial in wet AMD. This study design is based on extensive analysis conducted by the company’s clinical development team and incorporates feedback from Adverum’s scientific advisory board and key retina, uveitis and gene therapy experts.
“The long-term efficacy seen in the OPTIC trial after a single injection of ADVM-022 has been remarkable for my patients, who required frequent injections prior to entering the trial. The long-term safety data supports using the lower 2E11 vg/eye dose and a new lower 6E10 vg/eye dose with an enhanced steroid prophylaxis regimen. I look forward to evaluating ADVM-022’s potential to provide a safe and durable gene therapy from a single, in-office injection in patients with wet AMD in the upcoming Phase 2 trial,” said Arshad M. Khanani M.D., M.A., managing partner and director of clinical research, Sierra Eye Associates, member of Adverum’s Scientific Advisory Board, and the highest enrolling investigator in the wet AMD Phase 1 OPTIC trial.
Review of ADVM-022 Program:
During the second half of 2021, Adverum undertook a comprehensive review of the company’s ADVM-022 program, including analysis of its preclinical and clinical data. The review solidified the following rationale underpinning the development strategy and Phase 2 study design outlined today for ADVM-022 in wet AMD:
Leadership Update:
Today, Adverum indicated its plans to hire a chief development officer and a chief medical officer. Additionally, the board of directors is actively pursuing the addition of two new directors with gene therapy and operational expertise with the departures of Mehdi Gasmi, Ph.D. and Thomas F. Woiwode, Ph.D. from the Board, reported separately today.
“On behalf of Adverum and its board, I would like to thank Mehdi and Tom for their invaluable contributions, distinguished service and counsel over the years. Mehdi was instrumental in advancing development of ADVM-022, serving as Adverum’s past president and chief scientific officer before joining the Board in 2019. Tom has been a tremendous board member and major investor, helping guide and finance the company from preclinical to clinical stage. We wish them both well in all their future endeavors,” said Patrick Machado, J.D., board chair of Adverum. “Adverum is in the process of considering additions to its board of directors, with a focus on adding further expertise in gene therapy and has engaged a search firm to identify a diverse slate of candidates.”
Expected Near-Term Milestones
About Adverum Biotechnologies
Adverum Biotechnologies (Nasdaq: ADVM) is a clinical-stage gene therapy company targeting unmet medical needs in 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 patients with wet age-related macular degeneration. 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 Adverum’s plans to advance a Phase 2 trial of ADVM-022 in wet AMD at 2 X 10^11 vg/eye dose and a lower 6 X 10^10 vg/eye dose; statements under the caption “Future Development of ADVM-022 for Wet AMD,” including Adverum’s expected current cash runway; Adverum’s plans to hire a chief development officer and a chief medical officer, and to add two new directors to the Board; and statements under the caption “Expected Near-Term Milestones.” 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 time and cost of product candidate development and regulatory uncertainties; 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; and other risks and uncertainties facing Adverum described more fully in Adverum’s Form 10-Q filed with the SEC on November 4, 2021, 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.
Inquiries
Anand Reddi
Vice President, Head of Corporate Strategy and External Affairs & Engagement
Adverum Biotechnologies, Inc.
T: 650-649-1358
Or
Laurence Watts
Gilmartin Group
T: 619-916-7620
E: laurence@gilmartinir.com
Source: Adverum Biotechnologies, Inc.
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