Exhibit 99.1
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Annexon Broadens Autoimmune Franchise with Advancement of Third Anti-C1q Product Candidate and Strategic Expansion into New Autoantibody-driven Diseases
– Advancing subcutaneous ANX009 candidate into Phase 1b program in Lupus Nephritis –
– Deepening ANX005 neuromuscular autoimmune pipeline with new Phase 2 program in Multifocal Motor Neuropathy –
– Annexon to host virtual autoimmune R&D event with leading experts on Wednesday, July 28, at 10:30 a.m. ET –
SOUTH SAN FRANCISCO, Calif., July 22, 2021 (GLOBE NEWSWIRE) — Annexon, Inc. (“Annexon”) (Nasdaq: ANNX), a clinical stage biopharmaceutical company developing a class of next generation complement medicines for patients with classical complement-mediated autoimmune and neurodegenerative disorders of the body, brain and eye, today announced the broadening of its autoimmune franchise through advancement of its third clinical-stage product candidate, ANX009, into Lupus Nephritis and expansion of the ANX005 clinical program into a second neuromuscular condition, Multifocal Motor Neuropathy (MMN).
“Nearly 24 million Americans suffer from antibody-mediated autoimmune diseases, many of which are orphan or rare diseases with no or limited treatment options,” said Douglas Love, Esq., president and chief executive officer of Annexon.1 “Annexon is focused on developing therapeutics that stop classical complement-mediated disease at the start by targeting C1q, the initiating molecule of the classical pathway. Our upstream complement approach has broad potential to deliver multiple, differentiated, first-in-class therapies for patients across a spectrum of autoantibody-driven autoimmune diseases. We are excited to expand our portfolio of C1q inhibitors into additional autoimmune indications with high unmet need.”
Annexon’s Approach to Autoimmune Disease
Annexon is pioneering a targeted approach to tackling an array of antibody-mediated autoimmune diseases by inhibiting C1q and the early classical complement pathway. Using a rigorous precision medicine approach to measure aberrant complement activity, Annexon is sharply focused on enhancing the probability of success by identifying the indications and patients most likely to respond to anti-C1q therapy and developing a class of next generation complement medicines with improved efficacy and safety characteristics. Annexon’s autoimmune franchise, spanning neuromuscular, hematologic and nephritic indications, is well-supported by C1q’s unique mechanism of action, a comprehensive and growing scientific and clinical dataset and Annexon’s deep experience in the classical complement pathway.
Advancing ANX009 into Phase 1b Study in Lupus Nephritis
Annexon’s third clinical-stage product candidate, ANX009, is a subcutaneous C1q inhibitor developed for antibody-mediated autoimmune diseases of blood and vascular tissues. In a recently completed Phase 1 first-in-human (FIH) study of ANX009 in healthy volunteers, the dose-escalation study demonstrated:
| • | | ANX009 was well-tolerated at all dose levels and no drug-related safety signals were observed |
| • | | A clear dose response in single ascending dose cohorts, with robust C1q inhibition at higher doses |