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

Dr. Fischer continued, “We are pleased with the promising emerging LUNA clinical activity and safety data. At AAO this year, we look forward to presenting updated long-term follow-up data from the OPTIC trial, showing aflibercept protein levels out to four years, and clinical efficacy and safety data out to three years after a single Ixo-vec injection. We also look forward to providing initial LUNA clinical activity and safety data once a meaningful subset of patients have completed the corticosteroid prophylactic taper regimens.”

“The preliminary aqueous aflibercept protein data are consistent with levels known to be therapeutic and suggest that, in previously-treated neovascular age-related macular degeneration patients, both the 2E11 and 6E10 doses of Ixo-vec have the potential for sustained efficacy after a single administration,” 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 principal investigator of the LUNA and the OPTIC trials. “Ixo-vec utilizes the 7m8 capsid developed via directed evolution to enhance retinal transduction and to deliver therapy where it is needed most. These results from the LUNA study could be clinically meaningful as the aflibercept levels measured in this trial are comparable to the sustained aflibercept levels seen in patients treated in the OPTIC trial.”

Ixo-vec Phase 2 LUNA Preliminary Aflibercept Protein Level Data Highlights

Background:

• Ixo-vec is an aflibercept-encoding AAV.7m8 vector designed via directed evolution to cross the inner limiting membrane, enabling in-clinic IVT delivery and enhanced retinal transduction.
• Aqueous aflibercept protein levels in LUNA
  • The Phase 2 LUNA trial was designed to inform the selection of Ixo-vec dose(s) and corticosteroid prophylactic regimen(s) for the design of Phase 3 registrational trials.
  • Aqueous aflibercept levels measured in LUNA at this early week 14 time point are a predictive biomarker of the higher and therapeutically relevant aflibercept levels in the retina and choroid.
  • Non-human primate data confirm robust expression of aflibercept in the retina and choroid after a single IVT injection of Ixo-vec at levels approximately nine-fold higher than those measured in the aqueous humor.
• OPTIC clinical activity and safety
  • In OPTIC, the 2E11 dose of Ixo-vec performed well through two years, demonstrating efficacy that remains highly promising, with an acceptable safety profile.
  • Patients demonstrated early aflibercept levels sustained through at least three years of follow-up and also demonstrated clinical benefit, including vision maintenance, fluid control and a significant reduction in treatment burden.
  • OPTIC patients with a broad range of aqueous aflibercept levels achieved clinical benefit. Notably one subject had an 85% reduction in annualized supplemental aflibercept injections over 45 months of follow up and had aflibercept levels at multiple time points below or at the threshold of the limit of quantification of our assay (data on file).