Annexon Says Phase 3 Study Of ANX005 In GBS Met Primary Goal

(RTTNews) - Annexon, Inc. (ANNX) on Tuesday said that the Phase 3 trial of ANX005 in patients with Guillain-Barre syndrome (GBS) met its primary goal. GBS is a rare auto immune disorder affecting the nerves.

In the Phase 3 study, a single infusion of ANX005 30 mg/kg achieved a highly statistically significant 2.4-fold improvement on the GBS-disability scale (GBS-DS) at week 8. ANX005 30 mg/kg treatment also showed improvements on key secondary endpoints, including early gains in muscle strength, fewer days on artificial ventilation, and reduction in nerve damage compared with placebo.

Real-World Evidence (RWE) comparability data and BLA submission are expected in first half of 2025.