Annexon, Inc. announced the completion of enrollment in the Phase 2 ARCHER trial evaluating its anti-C1q candidate, ANX007, in patients with geographic atrophy (GA). Annexon plans to report topline data on the primary endpoint in the first half of 2023, following 12 months of treatment, with full data expected after the conclusion of the six-month off-treatment period. GA, also known as atrophic age-related macular degeneration (AMD) or dry AMD, has a genetic link to aberrant complement activity and can lead to blindness caused by damaged and dying retinal cells.

Currently, there are no approved treatment options to prevent the onset or progression of GA. It is estimated that one million people in the United States and three million people globally suffer from GA. ANX007 is formulated for intravitreal administration and purposefully designed for localized inhibition of C1q and the classical cascade.

In a Phase 1b trial, ANX007 was well-tolerated and demonstrated full target engagement and inhibition of C1q in the eye for at least four weeks. ARCHER is a randomized, multi-center, double-masked, placebo-controlled Phase 2 clinical trial that enrolled a total of 270 patients with GA. The trial will evaluate both monthly and every other month dosing schedules of ANX007.

Patients will be stratified by lesion location, with nearly half of enrolled participants having non-foveal lesions, a risk factor for more rapid progression. The primary efficacy endpoint will assess change in GA lesion area, as evaluated by fundus autofluorescence (FAF).