BRISBANE, Calif., Aug. 27, 2025 (GLOBE NEWSWIRE) -- Annexon, Inc. (Nasdaq: ANNX), a biopharmaceutical company advancing a late-stage clinical platform of novel therapies for people living with devastating classical complement-mediated neuroinflammatory diseases of the body, brain, and eye, today announced that Douglas Love, Esq., president & chief executive officer, will participate in fireside chats during the following September investor conferences: Wells Fargo Healthcare Conference on Wednesday, Septemb ...

Core Insights - Annexon, Inc. announced that its product vonaprument has been selected by the European Medicines Agency (EMA) for the Product Development Coordinator (PDC) pilot, which aims to enhance regulatory support for promising therapies [1][4] - Vonaprument is positioned to potentially be the first approved treatment for dry age-related macular degeneration (AMD) with geographic atrophy (GA) in both Europe and the U.S., focusing on preserving visual acuity and visual structures [1][2] Company Overview - Annexon, Inc. is a biopharmaceutical company dedicated to developing novel therapies for neuroinflammatory diseases affecting the body, brain, and eye, with a focus on classical complement-mediated conditions [1][10] - The company’s approach targets C1q, a key molecule in the classical complement pathway, which is implicated in neurodegeneration [10] Product Development - Vonaprument is a first-in-kind, non-pegylated antigen-binding fragment designed to block C1q locally in the eye, showing significant vision preservation in clinical trials [2][6] - The product has received both Priority Medicine (PRIME) designation in Europe and Fast Track designation from the U.S. FDA, indicating its potential therapeutic advantages [2][7] Clinical Trials - The ongoing Phase 3 ARCHER II trial has enrolled over 630 patients with advanced dry AMD/GA, with a primary endpoint focused on preventing a ≥15-letter loss in best corrected visual acuity (BCVA) [5][8] - Topline data from the ARCHER II trial is expected in the second half of 2026, following the completion of patient enrollment in July 2025 [4][5] Market Context - Dry AMD and GA are significant causes of blindness in the elderly, affecting approximately one million people in the U.S. and eight million globally, highlighting the urgent need for effective treatments [9] - Current approved therapies have not demonstrated significant efficacy in preventing vision loss, underscoring the potential market opportunity for vonaprument [9]

Expedited Enrollment Surpassing 630 Targeted Participants Underscores the Strong Demand for a Therapy Focused on Vision Preservation Phase 3 ARCHER II Trial Design and Rationale to Be Presented at ASRS, a Leading Meeting for Retina Science and Innovation Topline Pivotal Phase 3 Data Expected in the Second Half of 2026 Potential for Vonaprument to Be the First Treatment Approved in Europe and the U.S. for Dry AMD with Geographic Atrophy Based on Protection of Visual Acuity and Structural Measures BRISBANE, C ...

Core Insights - Annexon, Inc. has appointed Dr. Lloyd Clark as senior vice president of ophthalmology strategy and innovation, bringing over 25 years of experience in retina diseases and drug development [1][3] - The investigational therapy ANX007 is the only treatment shown to significantly preserve vision and central retinal photoreceptors in patients with dry age-related macular degeneration (AMD) with geographic atrophy (GA) [2][3] - The Phase 3 ARCHER II trial for ANX007 is expected to complete enrollment by Q3 2025, with topline data anticipated in the second half of 2026 [2][6] Company Overview - Annexon, Inc. focuses on developing novel therapies for neuroinflammatory diseases, targeting the classical complement pathway to prevent tissue damage [7] - The company aims to address significant unmet needs in the treatment of neurodegenerative and ophthalmic diseases, with a pipeline that includes investigational drug candidates for over 8 million patients globally [7] Product Details - ANX007 is designed to block C1q locally in the eye and is currently being evaluated in the pivotal Phase 3 ARCHER II trial, which will enroll approximately 630 patients [2][6] - The primary endpoint of the ARCHER II trial is to prevent a ≥15-letter loss in best corrected visual acuity (BCVA), a well-established functional endpoint for ophthalmology drug approvals [6] Market Context - Dry AMD with GA is a leading cause of blindness affecting over 8 million patients worldwide, with no approved therapies currently available to preserve vision [2][4] - The addition of Dr. Clark to the Annexon team is seen as a strategic move to enhance the company's position in the retina community and improve treatment options for patients with dry AMD [3]

Core Insights - The International Guillain-Barré Syndrome Outcomes Study (IGOS) presented real-world evidence showing improved outcomes with tanruprubart compared to current standards of care in matched patient populations [1][2] - Tanruprubart, a first-in-kind monoclonal antibody, is designed to block C1q to halt neuroinflammation and nerve damage in Guillain-Barré Syndrome (GBS) [2][3] - The drug has received Fast Track and Orphan Drug designations from the U.S. FDA and the European Medicines Agency for GBS treatment [5] Company Overview - Annexon, Inc. is focused on developing novel therapies for classical complement-mediated neuroinflammatory diseases affecting the body, brain, and eye [1][7] - The company aims to deliver innovative treatments targeting C1q to prevent tissue damage and loss in various neuroinflammatory conditions [7] - Annexon's pipeline includes investigational drug candidates addressing unmet needs in autoimmune, neurodegenerative, and ophthalmic diseases, potentially benefiting over 8 million people globally [7] Industry Context - GBS is a rare autoimmune disease with no FDA-approved therapies, characterized by rapid progression and severe weakness, often leading to paralysis [2][6] - The disease results in over 22,000 hospitalizations annually in the U.S. and Europe, contributing to significant morbidity and economic costs to the healthcare system [6] - The long-term burden of GBS has led to a multi-billion-dollar annual economic impact on the U.S. healthcare system [6]