Leading global experts in the GBS field highlighted the significant unmet need and opportunity to transform the GBS treatment landscape with a targeted immunotherapy approach, as well as additional Phase 3 analyses of early and durable treatment effects important to patients and the medical community.
'ANX005 rapidly suppressed neuroinflammation and validated the role of C1q inhibition in GBS during the active phase of disease, leading to highly statistically significant improvements across multiple endpoints and over multiple timepoints versus placebo,' said
Dr.
Summary of Phase 3 Data with ANX005 30 mg/kg Treatment
GBS-Disability Scale (GBS-DS)
Primary endpoint at Week 8: 2.41-fold higher likelihood of being in a better state of health with ANX005 vs. placebo (p = 0.0058)
Week 1: 7.22-fold higher likelihood of being in a better state of health with ANX005 vs. placebo (p < 0.0001)
Week 4: 2.49-fold higher likelihood of being in a better state of health with ANX005 vs. placebo (p = 0.0073)
Week 26: 2.5 times more patients had fully recovered to a normal / pre-disease state of health (GBS-DS = 0) with ANX005 (21.5%) vs. placebo (8.6%) (OR 4.14, p = 0.0092)
Week 8 responder analysis (pre-specified sensitivity analysis): 2-times more patients improved 3 points or more with ANX005 (28.2%) vs. placebo (13.6%) (p = 0.0309)
Week 8 dichotomy analysis (pre-specified sensitivity analysis): 2.5-times more patients were able to run or better ANX005 (29%) vs. placebo (12%) (OR 3.34, p = 0.0065)
Functional Measures
Walking 31 days earlier with ANX005 treatment (56 days) vs. placebo (87 days) (p = 0.0211)
Off ventilation 28 days earlier with ANX005 treatment (20 days) vs. placebo (48 days) (p = 0.0356)
Patients with North American and European baseline characteristics
Week 1: 8.8-point improvement in muscle strength measured by
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