Annexon (NASDAQ:ANNX) Reports Positive Results from Real-World Evidence Study for ANX005 Treatment in Guillain-Barré Syndrome

On December 16, 2024, Annexon, Inc. (“Annexon” or the “Company”) revealed encouraging findings from a recent real-world evidence (RWE) study assessing the efficacy of ANX005 in treating Guillain-Barré Syndrome (GBS). This acute neuromuscular disease lacks FDA-approved treatments, making ANX005 a potentially pivotal therapeutic candidate targeting disease progression.

The study was conducted in collaboration with the International GBS Outcome Study (“IGOS”) investigators, comparing patients treated with ANX005 30 mg/kg to a matched cohort from the IGOS global registry who received intravenous immunoglobulin (“IVIg”) or plasma exchange (“PE”). Notably, those treated with ANX005 exhibited faster and greater improvement in muscle strength and disability, with reduced need for mechanical ventilation and shorter durations in intensive care.

Douglas Love, Annexon’s President and CEO, expressed optimism over the consistent positive outcomes seen with ANX005, reinforcing the drug’s potential as a promising GBS therapy. The Company aims to engage with regulators based on these compelling results, with plans to submit a Biologics License Application in the first half of 2025.

The study, involving 79 patients in each cohort, emphasized the measurable benefits of ANX005 over traditional treatments like IVIg or PE. Findings included a significant improvement in muscle strength, enhanced health status, reduced need for ventilation, and shorter ICU stays among ANX005-treated patients, potentially alleviating the overall burden of GBS care.

Hugh Willison, a member of the IGOS Steering Committee, noted the rapid and enhanced benefit observed in patients receiving ANX005, showcasing the drug’s potential utility across a broad GBS patient population. The results presented a robust case for ANX005’s efficiency in halting autoimmune damage to nerve cells, facilitating quicker recovery and improved outcomes for GBS patients.

The Company’s Phase 3 trial previously showed favorable results of ANX005 treatment on GBS patients, indicating expedited recovery and reduced mechanical ventilation requirements compared to placebo. With Fast Track and Orphan Drug designations from the FDA and EMA, ANX005 continues to demonstrate promise as a pioneering targeted therapy for GBS.

GBS, a severe neurological condition affecting thousands annually in the U.S. and Europe, entails significant morbidity and mortality, underscoring the urgent need for effective treatments. Annexon’s innovative approach to combat classical complement-driven neuroinflammation offers hope for patients battling neuroinflammatory diseases.

Investors can access added details from Annexon’s conference call, analyzing the RWE study results, emphasizing the significance of ANX005’s potential advances in the GBS treatment landscape. The Company remains committed to delivering transformative therapies to enhance patient outcomes and quality of life.

This article was generated by an automated content engine and was reviewed by a human editor prior to publication. For additional information, read Annexon’s 8K filing here.

About Annexon

Annexon, Inc, a clinical-stage biopharmaceutical company, discovers and develops medicines for treating inflammatory-related diseases. Its lead candidate is ANX005, an investigational full-length monoclonal antibody, which is in Phase 3 clinical trial for the treatment of patients with guillain-barré syndrome; completed Phase II clinical trial for treating Huntington's disease; and in Phase II clinical trial for the treatment of amyotrophic lateral sclerosis.