Annexon has reported topline results from its ARCHER Phase II clinical trial of ANX007 for the treatment of patients with geographic atrophy (GA), a disease of vision loss.
The multi-centre, randomised, double-masked, sham-controlled Archer trial enrolled 270 patients to evaluate the efficacy and safety of ANX007 in patients with GA secondary to age-related macular degeneration.
Both female and male patients with foveal and non-foveal vision loss with an average age of 80 years were enrolled out of which 96% were from the US.
The study demonstrated a statistically significant, dose-dependent preservation of visual function during the 12-month treatment period.
Patients who received ANX007 monthly and every-other-month were protected against vision loss, as measured by changes from baseline in the functional endpoint of best corrected visual acuity.
Reduction in risk of 15-letter loss was observed in the monthly and in the every-other-month treated group of 72% and 48%, respectively.
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The data support ANX007’s differentiated mechanism of action and represent the first demonstration of a complement-based therapy to protect against vision loss in the study.
However, the primary endpoint of mean rate of change in GA lesion area compared against sham over the 12-month period failed to reach statistical significance.
ANX007 was well tolerated in both monthly and every-other-month treated groups.
Annexon CEO Douglas Love said: “Based on the ARCHER trial results, we plan to engage with regulators to determine the optimal path forward to bring ANX007 to patients as expeditiously as possible.”