Annexon, Inc. (ANNX) announced on Tuesday that its Phase 3 trial for ANX005 in patients with Guillain-Barre syndrome (GBS) successfully met its primary endpoint. GBS is a rare autoimmune disorder that affects the nervous system.
In this Phase 3 study, a single infusion of 30 mg/kg of ANX005 resulted in a highly statistically significant 2.4-fold improvement on the Guillain-Barre syndrome disability scale (GBS-DS) by the eighth week. The 30 mg/kg treatment of ANX005 also demonstrated notable improvements in key secondary endpoints, such as early gains in muscle strength, a reduction in the number of days on artificial ventilation, and decreased nerve damage compared to the placebo group.
Real-World Evidence (RWE) comparability data and the submission of a Biologics License Application (BLA) are anticipated in the first half of 2025.
