Annexon Presents Results From Completed Pivotal Phase 3 Trial Of C1q-Targeted Immunotherapy, ANX005 In Guillain-Barré Syndrome

Author: Benzinga Newsdesk | June 25, 2024 05:02pm

Key Findings from the Phase 3 GBS Trial of ANX005 30 mg/kg Treatment

• Phase 3 trial informed by dose-ranging Phase 1b trial, replicating earlier results
• Demonstrated a highly statistically significant effect on primary endpoint of GBS-DS, further supported by multiple prespecified sensitivity analyses
• Defined the effective treatment window during the active phase of GBS, an acute disease
• Early, robust and durable treatment effects expedited patient recovery
• Single dose administration of ANX005 was generally well-tolerated with mostly mild to moderate adverse events, no increased infection rate while not requiring vaccination or prophylactic antibiotics, and a profile similar to placebo

Posted In: ANNX