Annexon, Inc. (NASDAQ: ANNX), a biopharmaceutical company, has presented new findings from its phase 2 Archer study for anx007 in geographic atrophy (GA) due to dry age-related macular degeneration (AMD) at the American Academy of Ophthalmology (AAO) 2024 annual meeting. The data reveals that anx007 demonstrated enhanced protection of vision and greater preservation of central photoreceptor cells in a subpopulation of patients with less advanced disease as measured by the photoreceptor ellipsoid zone (EZ) in the central fovea.
Here are the key highlights of the new data presented at AAO: 0% (0/56) anx007 monthly-treated patients with less advanced disease lost 15 letters, or three lines on an eye chart, vs. 17% (10/59) sham patients (nominal p-value 0.0013). 6% (5/89) anx007 monthly-treated overall patients lost 15 letters vs. 21% (19/89) sham overall patients (nominal p-value 0.0021). 61% decrease in EZ loss between anx007 and sham in patients with < 80% EZ loss at baseline (nominal p-value 0.0575). 48% decrease in EZ loss between anx007 and sham in patients with < 98% EZ loss at baseline (nominal p-value 0.0218).
Anx007 is designed to selectively inhibit c1q, the initiating molecule of the classical complement pathway and a key driver of neurodegeneration. It has been granted fast track designation from the Food and Drug Administration and is the first therapeutic candidate for the treatment of GA to receive priority medicine (PRIME) designation in the EU.
In the randomized, multi-center, double-masked, sham-controlled phase 2 Archer clinical trial, anx007 demonstrated consistent protection against vision loss across multiple measures in a broad population of patients with GA. The treatment effect of anx007 increased over the course of the on-treatment portion of the study, suggesting that it may provide a growing and durable treatment effect over time.
Dry AMD and GA are chronic progressive neurodegenerative disorders of the retina involving the loss of photoreceptor synapses and cells in the outer retina. GA affects an estimated one million people in the United States and eight million people globally.
Annexon Biosciences is focused on harnessing neuroinflammation to advance potentially first-in-kind treatments for neuroinflammatory diseases of the body, brain, and eye. Their pipeline includes investigational drug candidates designed to address the unmet needs of over 8 million people worldwide.
The pivotal phase 3 Archer II data for anx007 is expected in the second half of 2026. Today the company's shares have moved 1.6% to a price of $7.6. Check out the company's full 8-K submission here.