Annexon Biosciences Completes Enrollment in ARCHER Phase 2 Trial of Novel C1q Inhibitor, ANX007, in Patients with Geographic Atrophy

Topline efficacy and safety data expected in first half of 2023

Excerpt from the Press Release:

BRISBANE, Calif., April 07, 2022 (GLOBE NEWSWIRE) — Annexon, Inc. (Nasdaq: ANNX), a clinical-stage biopharmaceutical company developing a new class of complement medicines for patients with classical complement-mediated autoimmune, neurodegenerative and ophthalmic disorders, today 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.

“We are very pleased to have completed enrollment in our ARCHER trial ahead of schedule, which is a testament to the strong efforts by our team and the enthusiasm among patients and their treating physicians for a novel treatment,” said Douglas Love, Esq., president and chief executive officer of Annexon. “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. We’re continuing to follow patients in the trial and look forward to assessing and reporting initial findings in the first half of 2023.”

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