Exhibit 99.1
Annexon Provides Update on ARCHER II Global Registrational Program in Geographic Atrophy
Patient Dosing Initiated in Phase 3 ARCHER II Trial of C1q Inhibitor ANX007; Topline Data Expected in Second Half 2026
Additional Data from Phase 2 ARCHER Trial Demonstrated Both Significant Vision Protection in Standard and Low Light Conditions, and
Significant Structural Protection in Regions of the Eye Important for Visual Acuity
BRISBANE, Calif., August 5, 2024 -
Annexon, Inc. (Nasdaq: ANNX), a biopharmaceutical company advancing novel complement therapies for neuroinflammatory diseases of the body, brain and eye, today announced patient dosing was initiated in the global pivotal Phase 3 ARCHER II
trial evaluating ANX007 for the treatment of geographic atrophy (GA), the only GA pivotal program utilizing visual protection as the global regulatory-aligned primary end point. Additionally, Annexon announced new data regarding protection of vision
and vision-related retinal structure from the Phase 2 ARCHER trial, supporting the disease modifying potential of ANX007 for the treatment of GA. These data were recently presented on July 18, 2024, at the American Society of Retina Specialists
(ASRS) Annual Scientific meeting.
GA is a chronic, progressive neurodegenerative disease that is the leading cause of blindness for over 8 million
elderly people worldwide, resulting in the loss of independence and major disruption in their daily lives. Although there are two currently FDA-approved treatments to slow disease progression in GA, there are
currently no approved treatments indicated to protect vision in GA.
ANX007 is the only investigational medicine for GA to date to show in a
randomized clinical trial significant protection of both visual acuity and key visual structures in regions of the eye essential for vision, said Douglas Love, president and chief executive officer of Annexon. These data underscore
ANX007s potential best-in-class profile and make all the more exciting the initiation of the ARCHER II global, pivotal Phase 3 study designed to treat patients
impacted by this devastating disease at a vulnerable stage in their lives. Assuming success in the ARCHER II trial, ANX007 has the potential to be the first GA therapy approved to protect vision.
ARCHER II is a global, randomized, sham-controlled Phase 3 trial with topline data expected in the second half of 2026. The ANX007 registrational program has
received regulatory alignment with both the Food and Drug Administration (FDA) and the European Medicines Agency (EMA) on key study elements, including on using, for the first-time in GA, best corrected visual acuity (BCVA) protection against ≥15-letter loss as the primary outcome measure (equivalent to three lines on a standardized eye chart). In ARCHER II, ANX007 will be compared to sham control in a well-powered study with a robust safety
database that is expected to enroll approximately 630 patients. ANX007 is the only therapeutic candidate for GA to date to receive Priority Medicine (PRIME) designation in the European Union, and has been granted Fast Track designation from the FDA.
Eleonora Lad, MD, PhD, Vice Chair of Clinical Research at Duke Eye Center added, Treatments for GA have primarily focused on addressing lesion
growth by measuring protection of the retinal pigment epithelium (RPE), supportive cells that do not detect light across the retina. Unfortunately, current treatments have not translated to protection of clinically meaningful vision for patients.
The new analyses of the Phase 2 ARCHER trial are very encouraging, demonstrating protection of photoreceptors in the central fovea, the region of the retina needed for important activities such as reading, driving and seeing faces. These data shed
new insights into the mechanism of ANX007 to potentially modify disease activity, leading to protection of vision loss in GA.