Adverum Commences Mid-Stage Chronic Eye Disorder Candidate Study

Adverum Biotechnologies ADVM dosed first subject in the LUNA Phase 2 trial evaluating ixoberogene soroparvovec (Ixo-vec, formerly referred to as ADVM-022) for the treatment of wet age-related macular degeneration (wet AMD).

The LUNA trial is a double-masked Phase 2 trial, designed to assess the safety and efficacy of two dose levels of a single, in-office intravitreal injection of Ixo-vec for the treatment of wet AMD who are 50 years or older at approximately 40 sites in the U.S. and Europe.

The primary endpoints of the study are mean change in BCVA from baseline to one year and the incidence and severity of adverse events.

Key secondary objectives include the mean change in central subfield thickness (CST) from baseline to one year and assessing the effectiveness of prophylactic steroid regimens on minimizing inflammation.

Richard Beckman, Chief medical officer, commented: "Dosing the first subject in the Phase 2 LUNA study brings us a step closer to our mission of establishing gene therapy as a new standard of care for some of the leading causes of vision loss. We are excited that LUNA will allow us to explore a new, lower 6E10 dose that we hope will build on the robust, durable efficacy and safety profile already demonstrated with the 2E11 dose in the OPTIC trial.”

Additionally, LUNA will assess aflibercept protein expression starting at Week 10 and include an interim analysis at Week 26.

The company anticipates reporting initial data from the study, including aflibercept protein expression at Week 10 and an interim analysis at Week 26 during the year 2023.

Price Action : Adverum shares are trading around 6 percent higher at $1.12 on Wednesday.