Annexon expands Phase 3 trial for dry AMD with 24-month endpoint

Biotech company Annexon Inc. has amended its Phase 3 trial for its experimental therapy targeting geographic atrophy, a leading cause of blindness in the elderly.

The trial, which was previously designed with a 12-month primary endpoint, will now include a 24-month endpoint to evaluate the long-term efficacy and safety of the treatment. Geographic atrophy is an advanced form of dry age-related macular degeneration (AMD) that results in progressive and irreversible vision loss.

Annexon’s therapy, ANX007, is an antibody fragment designed to inhibit C1q, a protein involved in the complement system that contributes to retinal cell damage in dry AMD. The company initiated the Phase 3 trial, known as the ARCHER study, in mid-2023, enrolling patients across multiple sites in the United States and Europe.

The addition of the 24-month endpoint follows discussions with regulatory authorities, including the U.S. Food and Drug Administration (FDA), to ensure the trial design aligns with potential approval requirements. Annexon stated that the extended timeline will provide critical data on the durability of treatment effects and potential slowing of disease progression.

Shares of Annexon were not immediately active in after-hours trading following the announcement. The company plans to provide further updates on trial progress as data becomes available.

Dry AMD affects approximately 5 million people globally, with limited treatment options currently available. If successful, ANX007 could represent a significant advancement in managing the condition.