Adverum Biotechnologies Announces Positive Aflibercept Protein Level Data from the LUNA Phase 2 Trial - Seite 3

Trial Design & Key Baseline Characteristics:

• The LUNA trial is evaluating the efficacy and safety of Ixo-vec in 60 subjects randomized equally between the 2E11 and 6E10 doses.
• LUNA was fully enrolled in August 2023, and as of the July 24, 2023 data cut-off, 12 patient samples have been collected and analyzed for aflibercept protein levels in the aqueous humor.
• The LUNA trial population has similar visual acuity and injection frequency baseline characteristics to the study population of OPTIC.
• In particular, the mean annualized anti-VEGF injection rate in the 12 months prior to Ixo-vec treatment in LUNA is approximately nine injections, indicating that these subjects require frequent injections, administered approximately every six weeks.

Aqueous Aflibercept Protein Expression Levels:

• Aflibercept protein data suggest Ixo-vec at the 2E11 and 6E10 doses deliver similar levels of aflibercept that are both within the therapeutically active range based on OPTIC and non-human primate data.
  

*In LUNA, 12 of 14 eligible subjects had aqueous taps as of the July 24, 2023 data cut-off date. Data are shown for nine LUNA subjects. The other three subjects (including subjects at both dose levels) had aflibercept levels below the limit of quantification (25ng/ml) of our ELISA assay.

Preliminary LUNA Clinical Activity and Safety Summary:

• Ixo-vec early clinical activity is encouraging and as anticipated, Ixo-vec has been generally well-tolerated with a favorable safety profile as of the data cut-off date.
• Over 90% of subjects were still receiving corticosteroid prophylactic taper as of the data cut-off date.

Anticipated Clinical Program Milestones

Q4 2023:	Presentation of OPTIC four-year Ixo-vec aflibercept protein expression data and three-year extension efficacy and safety data at the American Academy Ophthalmology (AAO) Meeting in November 2023.
Q4 2023:	LUNA preliminary efficacy and safety data.
Mid-2024:	Additional LUNA data, including the 26-week interim analysis.

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