Annexon, Inc. has completed enrollment in its Phase 3 ARCHER II trial for vonaprument, a drug targeting dry age-related macular degeneration (AMD) with geographic atrophy (GA). The trial enrolled over 630 participants, exceeding its target, and topline data is expected in the latter half of 2026. Vonaprument is a first-in-class, non-pegylated antigen-binding fragment (Fab) antibody designed to inhibit C1q, a key component of the complement pathway believed to drive neurodegeneration in the eye.
The rapid enrollment and upcoming data readout are crucial due to the substantial unmet medical need in this area. Currently, there are no approved treatments in Europe for dry AMD with GA, and options in the U.S. are limited. If successful, vonaprument could become the first therapy approved in both regions to address this debilitating condition, offering hope for patients facing progressive vision loss. The Phase 2 ARCHER trial demonstrated vonaprument’s potential to preserve vision, a clinically meaningful outcome for patients, and the Phase 3 trial is designed to confirm these findings.
The ARCHER II trial is a global, randomized, double-masked, and sham-controlled study. The primary endpoint is the prevention of significant vision loss (≥15-letter loss of best corrected visual acuity). Secondary endpoints include safety, low-luminance visual acuity, and photoreceptor integrity. Vonaprument has received Priority Medicine designation in Europe and Fast Track designation in the U.S., highlighting the regulatory agencies’ recognition of its potential.
The completion of enrollment marks a significant step towards potentially bringing a much-needed treatment to market for dry AMD with GA. Positive results from the ARCHER II trial could transform the treatment landscape for this condition, offering a new therapeutic approach based on C1q inhibition. This could lead to improved visual outcomes and quality of life for millions of patients worldwide affected by this currently untreatable disease.
Jon Napitupulu is Director of Media Relations at The Clinical Trial Vanguard. Jon, a computer data scientist, focuses on the latest clinical trial industry news and trends.
