Annexon has concluded subject enrolment in the Phase II ARCHER clinical trial of its anti-C1q candidate, ANX007, in individuals with geographic atrophy (GA).
An antigen-binding fragment (Fab), ANX007 is formulated for intravitreal administration. It is created for localised hindering of C1q and the classical complement pathway in neurodegenerative eye diseases.
The multicentre, randomised, double-masked, placebo-controlled trial enrolled a total of 270 GA patients.
It will assess monthly as well as alternate-month dosing regimen of ANX007.
Trial subjects will be categorised based on lesion location, with nearly 50% of the enrolled patients having non-foveal lesions, a risk factor for quicker progression.
Analysing the variation in the GA lesion area, as assessed by fundus autofluorescence (FAF) is the primary efficacy endpoint of the trial.
The company intends to report topline results on the primary endpoint in the first half of next year, following treatment for a year.
Furthermore, complete data is anticipated on concluding the off-treatment period of six months.
According to data from a Phase Ib trial, ANX007 demonstrated to be well-tolerated and showed full target engagement and C1q inhibition in the eye for a minimum of four weeks.
Annexon president and CEO Douglas Love said: “Excess classical complement activity in the retina is a potential driver of GA, and by stopping the classical complement pathway at its start, we believe we may halt the detrimental immune response and nerve damage that occurs in the eye.
“With nearly half of patients enrolled having non-foveal lesions, the ARCHER trial is designed to evaluate slowing of GA lesion growth in both patients who are at risk for faster progression and in the overall patient population.”