On April 7th, Annexon announced that they completed enrollment in the Phase 2 ARCHER clinical trial, which is studying the potential of ANX007 in patients with geographic atrophy (GA).
ANX007. An anti-C1q monoclonal antibody antigen-binding fragment (Fab)
ANX007 has been designed for intravitreal administration and has been designed for the specialized inhibition of the C1q and the classical complement pathway in ophthalmic neurodegenerative diseases. In the Phase 1b trial, this compound was well-tolerated and showed complete target engagement and inhibition of C1q in the eye for a minimum of four weeks. Annexon stated that their underlying reason for an anti-C1q agent is that excess classical complement activity in the retina is a possible trigger for GA. Therefore, by halting the start of the classical complement pathway, they believe they may stop the harmful effects of an immune response and collateral damage to ocular structures.
The ARCHER Phase 2 is a randomized, multi-centered, double-masked, and placebo-controlled clinical trial that included 270 patients with GA. ARCHER aims to evaluate the slowing of GA lesion growth in the overall study population and a subset of patients with non-foveal lesions, a known risk factor for faster progression. This trial will evaluate the dosing schedules of ANX007 that take place monthly and every other month. The primary endpoint of ARCHER is to assess the change in GA lesion from baseline by fundus autofluorescence (FAF). Initial results are expected in the first half of 2023.
The global burden of Geographic Atrophy
GA is the advanced stage of dry age-related macular degeneration (AMD). Studies have demonstrated a genetic link between GA and abnormal complement activity, resulting in damage to retinal cells and consequent vision loss. Presently, no treatment options have been approved to prevent the onset and advancement of GA. It is estimated that over eight million people worldwide suffer from this condition.