Annexon to Present Phase 2 ANX007 Data on Vision and Photoreceptor Protection in GA at Retina Society and Euretina Congress

14 September 2024

Annexon, Inc., a biopharmaceutical company listed on Nasdaq as ANNX, is developing innovative complement therapies targeting neuroinflammatory diseases affecting the body, brain, and eyes. The company recently announced its participation in the Retina Society’s 57th annual scientific meeting in Lisbon, Portugal, and the 24th annual Euretina Congress in Barcelona, Spain. During these conferences, Annexon will present detailed analyses of its Phase 2 ARCHER trial for ANX007, a novel treatment for geographic atrophy (GA).

ANX007 is a unique, non-pegylated antigen-binding fragment (Fab) designed to inhibit C1q within the eye through an intravitreal formulation. The drug aims to block the initiation of the classical complement pathway, a significant contributor to neurodegeneration in GA. The Phase 2 ARCHER trial demonstrated that ANX007 provided broad protection of vision in both standard and low light conditions, as well as significant preservation of key visual structures within the eye.

Douglas Love, the President and CEO of Annexon, highlighted the promising results of the ARCHER trial, stating that the data supports the potential for ANX007 to be the first treatment to protect vision in patients with GA. The company has already commenced a Phase 3 pivotal ARCHER II trial to further evaluate ANX007's efficacy, with data expected in the second half of 2026.

At the upcoming conferences, the presentations will focus on various aspects of ANX007's clinical performance. Dr. Glenn J. Jaffe from Duke Department of Ophthalmology will discuss the preservation of photoreceptors and prevention of visual acuity loss in GA during the Retina Society’s meeting. Dr. Usha Chakravarthy from Royal Victoria Hospital and Queens University of Belfast will present clinical results from the Phase 2 ARCHER trial at the Euretina Congress. Additionally, Dr. Paulo Eduardo Stanga of The Retina Clinic London will present an e-poster on the effect of ANX007 in protecting central macular structures.

Annexon will also host a sponsored symposium titled “C1q Driven Neurodegeneration in GA and Relationship to Structure,” featuring Dr. Jeff Heier from Ophthalmic Consultants of Boston. Other notable participants include Dr. Usha Chakravarthy and Dr. Paulo Eduardo Stanga, who will discuss the treatment’s safety, efficacy, and the link between structural preservation and visual function.

ANX007 has shown a promising ability to inhibit C1q and halt the classical complement pathway activation, which is critical in preventing synapse loss, inflammation, and neuronal damage associated with GA. The drug has received Fast Track designation from the FDA and Priority Medicine (PRIME) designation in the EU, underscoring its potential to offer significant therapeutic benefits over existing treatments.

The Phase 2 ARCHER trial was a randomized, multi-center, double-masked, sham-controlled study that demonstrated ANX007's consistent protection against vision loss in a broad patient population. The treatment provided statistically significant, time and dose-dependent protection as measured by several visual function parameters. Moreover, the protective effect of ANX007 was observed to increase over time and was maintained during a subsequent six-month off-treatment period, suggesting durable benefits.

Geographic atrophy (GA) is an advanced stage of dry age-related macular degeneration (AMD) characterized by the loss of photoreceptor cells in the retina. This progressive condition affects approximately one million people in the United States and eight million globally, causing significant visual impairment and emotional distress. Currently, no approved therapies significantly prevent vision loss in GA, highlighting the urgent need for effective treatments such as ANX007.

Annexon Biosciences is dedicated to advancing its late-stage clinical platform of novel therapies for neuroinflammatory diseases. By targeting upstream C1q, Annexon aims to block the classical complement inflammatory cascade and provide meaningful benefits across various autoimmune and neurodegenerative conditions. With promising data from ongoing clinical trials, the company is committed to bringing these potential treatments to patients as swiftly as possible.

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