Adverum Biotechnologies Announces Positive Aflibercept Protein Level Data from the LUNA Phase 2 Trial

- Initial aflibercept protein levels in LUNA suggest Ixo-vec at both the 2E11 and 6E10 doses delivers aflibercept protein levels within the therapeutically active range -

- Ixo-vec has been well tolerated with a favorable preliminary safety profile -

- Initial Phase 2 LUNA efficacy and safety data anticipated in Q4 2023 -

REDWOOD CITY, Calif., Sept. 26, 2023 (GLOBE NEWSWIRE) -- Adverum Biotechnologies, Inc. (Nasdaq: ADVM), a clinical-stage company that aims to establish gene therapy as a new standard of care for highly prevalent ocular diseases, today announced initial aflibercept protein expression data from its ongoing Phase 2 LUNA trial evaluating ixoberogene soroparvovec (Ixo-vec) for the treatment of wet age-related macular degeneration (wet AMD). New data announced today include aflibercept protein levels for both the 2E11 and 6E10 vg/eye doses, suggesting that both doses are within the therapeutically active range. Notably, these protein expression levels are consistent with levels observed in the OPTIC trial, in which aflibercept levels and corresponding clinical activity have been sustained in patients through multiple years of follow-up after a single Ixo-vec injection.

“This first data cut from the LUNA trial is highly encouraging, showing similar aflibercept expression levels at the 2E11 and 6E10 doses,” stated Laurent Fischer, M.D., president and chief executive officer of Adverum Biotechnologies. “Unlike the current standard of care that requires multiple bolus injections in the eye every year to maintain sufficient levels of aflibercept, gene therapy has the potential to dramatically reduce treatment burden for the life of the patient by delivering durable therapeutic levels of anti-VEGF. The aflibercept levels across the 2E11 and 6E10 doses are in the range observed in the OPTIC trial and in the range that was seen in previously presented non-human primate data. The efficacy of Ixo-vec at the 2E11 dose in OPTIC remain very promising. LUNA was designed to further optimize Ixo-vec's profile, by exploring improved corticosteroid prophylactic regimens and the potential to dose lower. Our preliminary LUNA data reinforce our hypothesis that Ixo-vec at both the 2E11 and 6E10 doses has the potential to produce a robust clinical activity with an acceptable safety profile.”