Annexon Advances Classical Complement Platform with Initiation of Global Phase 2 ARCHER Trial in Patients with Geographic Atrophy

SOUTH SAN FRANCISCO, Calif., March 01, 2021 (GLOBE NEWSWIRE) -- Today, Annexon, Inc. (“Annexon”) (Nasdaq: ANNX), a clinical stage biopharmaceutical company developing novel therapies for patients with classical complement-mediated disorders of the body, brain and eye, announced that patient dosing has begun in its Phase 2 ARCHER study of its anti-C1q therapy, ANX007, to treat Geographic Atrophy (GA). GA, also known as atrophic age-related macular degeneration (AMD) or dry AMD, can lead to blindness caused by damaged and dying retinal cells. Currently, there are no approved treatment options to prevent onset or progression of GA.

“We are pleased to have commenced this important Phase 2 trial, advancing ANX007 as a potential therapy for GA, a leading cause of blindness and highly burdensome disease which affects more than five million people worldwide,” said Douglas Love, Esq., president and chief executive officer of Annexon. “This program harnesses our targeted anti-C1q approach, fully inhibiting the classical complement pathway with the aim of halting the damaging immune response and nerve damage that occurs in the eye.”

“Geographic atrophy can have a profound impact on patients who lose their ability to drive, read and carry out normal daily functions,” said Peter K. Kaiser, M.D., Professor of Ophthalmology, Cole Eye Institute, Cleveland Clinic. “Targeting aberrant complement activity associated with the GA process has demonstrated great promise. Evaluating treatments that may reduce the rate of GA lesions growth and preserve visual function is important for these patients that have no treatment options today.”

About the Phase 2 ARCHER Clinical Trial and ANX007

The randomized, multi-center, double-masked Phase 2 trial is designed to evaluate the efficacy and safety of ANX007 in reducing the area of GA as evaluated by fundus autofluorescence (FAF) in patients with GA. Monthly and every other month dosing schedules will be evaluated.

ANX007 is an investigational monoclonal antibody antigen-binding fragment for the treatment of patients with complement-mediated neurodegenerative ophthalmic diseases. Formulated for intravitreal administration, ANX007 is designed to potently bind to C1q and inhibit activation of all downstream components of the classical complement cascade, including C3 and C5, but not to interfere with the normal function of C3 and C5 as part of other complement pathways. In Phase 1 studies, intravitreal ANX007 demonstrated full C1q inhibition at 29 days and was well tolerated by patients.

More information can be found at www.annexonbio.com.

About Annexon, Inc.

Annexon is a clinical-stage biopharmaceutical company developing a pipeline of novel therapies for patients with classical complement-mediated disorders of the body, brain and eye. The company’s pipeline is based on its platform technology addressing well-researched classical complement-mediated autoimmune and neurodegenerative disease processes, both of which are triggered by aberrant activation of C1q, the initiating molecule of the classical complement pathway. Annexon is deploying a disciplined, biomarker-driven development strategy designed to identify patients, and to measure target engagement and response to treatment. For more information, visit www.annexonbio.com.

Forward-Looking Statements

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Investor Contacts:
Jennifer Lew, Chief Financial Officer
Annexon Biosciences
jlew@annexonbio.com

Sara Michelmore
smichelmore@macbiocom.com

Media Contacts:
Miriam Mason
Annexon Biosciences
mmason@annexonbio.com

Caroline Rufo, Ph.D.
crufo@macbiocom.com