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