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On Tuesday, Annexon Inc ANNX released topline results from its Phase 3 trial in patients with Guillain-Barré syndrome (GBS), an autoimmune condition in which the immune system attacks the nerves . As Guillain-Barre syndrome progresses, muscle weakness can turn into paralysis. The Phase 3 trial met its primary endpoint, with ANX005 30 mg/kg achieving a statistically significant 2.
4-fold improvement on the GBS-disability scale at week 8. ANX005 30 mg/kg treatment also demonstrated improvements versus placebo on key secondary endpoints, including early gains in muscle strength and a median of fewer days on artificial ventilation. In a prespecified analysis, ANX005 30 mg/kg demonstrated a 31-day reduction in the median time to walk independently versus placebo.
ANX005 also provided an early reduction in the prespecified analysis of neurofilament light chain serum levels, a nerve damage biomarker (11.2% reduction relative to placebo). The Phase 3 trial, which enrolled 241 subjects in Bangladesh and the Philippines, evaluated two doses of ANX005-30 mg/kg and 75 mg/kg, which delivered rapid and complete suppression of complement activity but differed in duration of C1q inhibition.
The 30 mg/kg dose suppression lasted one week, and the 75 mg/kg dose suppression lasted two to three weeks. ANX005 75 mg/kg outperformed the placebo on multiple endpoints. However, it was not statistically significant on the primary endpoint of the GBS-disability scale at week 8.
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