ARCHER trial highlights protective effects of ANX007 on visual function
Click Here to Manage Email Alerts
SEATTLE — In the ARCHER trial, ANX007 did not meet the primary endpoint of mean rate of change in geographic atrophy lesion size compared with sham.
However, it demonstrated a novel neuroprotective mechanism of action across multiple visual function benefits.
“These were highly statistically significant for visual acuity endpoints and were dose and time dependent,” Jeffrey Heier, MD, said at the American Society of Retina Specialists annual meeting.
ANX007 (Annexon) is a Fab antibody fragment that selectively inhibits the complement component C1q. Heier said that C1q is a key driver of neurodegeneration that binds photoreceptor synapses and activates the classical pathway, leading to inflammation and cell loss.
In the ARCHER phase 2 trial, geographic atrophy patients with foveal and non-foveal lesions were randomly assigned to ANX007 5 mg monthly or every other month vs. sham. Treatment was for 12 months, and a 6-month off-treatment follow-up period is ongoing.
ANX007 did not meet the primary endpoint of significant reduction of geographic atrophy lesion area from baseline to month 12. However, it demonstrated significant dose-dependent and time-dependent protection from vision loss. Reduction in risk of more than 15 letter loss was 72% with monthly dosing and 48% with every other month dosing.
“Protection from vision loss was consistent across baseline characteristics for both monthly and every other month therapy,” Heier said. “This vision loss was consistent across different measures including 10-letter loss and 20-letter loss, again in a dose-dependent manner. Mean change in best corrected visual acuity at month 12 showed a trend for a dose-dependent response in ANX007-treated patients.”
Protection from vision loss was seen in foveal and non-foveal patients.
ANX007 provided consistent protection on additional measures, including low-luminance visual acuity and low-luminance visual deficit. It was generally well tolerated, with a similar rate of choroidal neovascularization across the groups. Three cases of endophthalmitis, one case of vascular occlusion and three cases of intraocular inflammation were reported.
“Planning for regulatory discussions and phase 3 studies are ongoing,” Heier said.
Collapse
Heier J, et al. Efficacy and safety of intravitreal injections of ANX007 in patients with geographic atrophy: Results of the ARCHER study. Presented at: American Society of Retina Specialists annual meeting; July 28-Aug. 1, 2023; Seattle.
Read more about
Click Here to Manage Email Alerts