Adverum Biotechnologies Inc (NASDAQ: ADVM) has announced the completion of its Investigational New Drug (IND) amendment with the US FDA and is planning to commence the Phase 2 LUNA study of ADVM-022, an intravitreal injection for the treatment of wet age-related macular degeneration (wet AMD).
ADVM-022 secures the international nonproprietary name
The US Adopted Names Council and World Health Organization’s Review Council have designated the international nonproprietary name for ADVM-022 as ixoberogene soroparvovec (Ixo-vec).
CEO and President Laurent Fischer said, “On the heels of receiving the European Medicines Agency PRIME designation in the European Union, highlighting the unmet medical need in the current treatments for wet AMD, we are delighted to advance Ixo-vec into Phase 2 development. We amended our IND and are on track to dose the first patient in the Phase 2 LUNA trial for the treatment of wet AMD in the coming months. We have also optimized our manufacturing strategy and have a scalable approach designed to provide an ample supply of Ixo-vec to support our clinical development program through biologics license application filing.”
Furthermore, the company has reorganized its business operations, prioritizing Ixo-clinical vec’s development and concentrating its pipeline approach on the most common ocular disorders. This has included reducing manpower and expenses.
Adverum has an adequate cash runway to run to 2025
By extending our anticipated cash runway by roughly one year through 2025 as a result of the restructuring initiatives, the company hopes to fully support the advancement of the ADVM-022 drug and have access to resources past the one-year topline LUNA outcomes predicted by the current development timeframe. Adverum had cash, cash equivalents, and investments of $271.1 million as of March 31, 2022.
The company is delighted to commence the Phase 2 LUNA study. The trial was designed after a substantial review of data from all 55 study subjects so far treated with ADVM-022 single injection. Some of the patients have shown stable and continuous aflibercept expression for three years. Adverum has deepened its understanding of adeno-associated virus (AAV) mediated ocular gene therapy that includes an inflammatory response to AAV, which is informing the strategy to mitigate immunogenicity.
