Adverum Biotechnologies Proceeds with IND Amendment for ADVM-022 Phase 2 Trial in Wet AMD After Receiving Requested Type C Meeting Feedback from the FDA

Rhea-AI Summary

Adverum Biotechnologies (Nasdaq: ADVM) has announced plans to complete the Investigational New Drug (IND) amendment process by mid-2022, allowing them to initiate the Phase 2 trial of ADVM-022 for wet age-related macular degeneration (wet AMD) in the third quarter of 2022. Following feedback from the FDA, the trial will evaluate two dosage levels of ADVM-022, aiming for a single intravitreal injection as a durable treatment option. The planned trial responds to the urgent need for long-lasting treatments for wet AMD patients.

Positive

• FDA feedback received on the clinical development plan for Phase 2 trial of ADVM-022.
• IND amendment process expected to be completed by mid-2022.
• First patient dosing planned for the third quarter of 2022.

Negative

• Potential risks and uncertainties associated with novel technology affecting development timelines.

Company anticipates completing IND amendment process by mid-2022 to enable dosing of the first patient in the planned Phase 2 trial during Third Quarter of 2022

REDWOOD CITY, Calif., April 06, 2022 (GLOBE NEWSWIRE) -- Adverum Biotechnologies, Inc. (Nasdaq: ADVM), a clinical-stage gene therapy company targeting unmet medical needs in ocular and rare diseases, today announced that it has received feedback via a Type C meeting written response from the U.S. Food and Drug Administration (FDA) related to Adverum’s planned Phase 2 trial of ADVM-022 in wet age-related macular degeneration (wet AMD). Adverum requested the FDA’s feedback to ensure alignment with the regulatory agency ahead of filing the Investigational New Drug (IND) amendment for the Phase 2 trial. The trial is designed to evaluate the 2 X 10^11 vg/eye dose and a new, lower 6 X 10^10 vg/eye dose of ADVM-022, along with new enhanced prophylactic steroid regimens, including local steroids and a combination of local and systemic steroids.

“We are extremely pleased to have feedback from the FDA regarding our clinical development plan for a Phase 2 trial of ADVM-022 in wet AMD. We are looking forward to completing the IND amendment process by mid-2022 and remain on track to initiate our Phase 2 study in the third quarter of 2022,” stated Laurent Fischer, M.D., president and chief executive officer at Adverum Biotechnologies. “ADVM-022 is a single, intravitreal injection gene therapy product that we believe has the potential to provide a durable and safe treatment option that addresses the needs of wet AMD patients, caregivers, retina specialists and health systems.”

“As an investigator in Adverum’s OPTIC trial, I am pleased to give my patients the option for a long-lasting, durable treatment for wet AMD,” commented David S. Boyer, M.D., physician at Retina-Vitreous Associates Medical Group and member of Adverum’s Scientific Advisory Board. “It is clear that newer long-acting anti-VEGF treatments are needed, especially one that reduces the burden of frequent anti-VEGF injections that many patients currently have to endure. The work that Adverum is doing to advance ADVM-022 as a treatment option is invaluable for patients and the field.”

Expected Near-Term ADVM-022 Development Milestones

• Mid-2022 – Complete IND amendment process to enable initiation of Phase 2 trial of ADVM-022 in wet AMD
• Third Quarter of 2022 – Plan to dose first patient in a Phase 2 trial of ADVM-022 in wet AMD

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 neovascular or 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 initiate a Phase 2 trial of ADVM-022 in wet AMD at the 2 X 10^11 vg/eye dose and a new, lower 6 X 10^10 vg/eye dose; and statements under the caption “Expected Near-Term ADVM-022 Development 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.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 Annual Report on Form 10-K for the year ended December 31, 2021 filed with the SEC on March 29, 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.

Inquiries

Anand Reddi
Vice President, Head of Corporate Strategy and External Affairs & Engagement
Adverum Biotechnologies, Inc.
T: 650-649-1358

Or

Investors:
Laurence Watts
Gilmartin Group
T: 619-916-7620
E: laurence@gilmartinir.com

Media:
Jennifer Arcure
Canale Communications
T: 917-603-0681
E: Jennifer.Arcure@canalecomm.com

Source: Adverum Biotechnologies, Inc.

FAQ

What is the planned Phase 2 trial of ADVM-022 by Adverum?

The Phase 2 trial will evaluate ADVM-022 for treating wet AMD, testing two dosage levels, 2 X 10^11 vg/eye and 6 X 10^10 vg/eye.

When does Adverum expect to initiate the Phase 2 trial for ADVM-022?

Adverum plans to initiate the Phase 2 trial by the third quarter of 2022.

What feedback did Adverum receive from the FDA regarding ADVM-022?

Adverum received feedback from the FDA via a Type C meeting written response that supports their clinical development plan for ADVM-022.

What are the expected near-term milestones for ADVM-022?

Expected milestones include completing the IND amendment process by mid-2022 and dosing the first patient in the Phase 2 trial in Q3 2022.

What are the potential impacts of the ADVM-022 trial on the market?

If successful, ADVM-022 could offer a durable treatment option for wet AMD patients, addressing a significant unmet medical need in the ophthalmology market.