Kiniksa announces results from phase III trial of mavrilimumab in COVID-19-related ARDS.
Mavrilimumab is an investigational fully human monoclonal antibody that targets granulocyte macrophage colony stimulating factor receptor alpha (GM-CSFRalfa). The Phase II/III trial is a global, double-blind, placebo-controlled study designed to evaluate the safety and efficacy of mavrilimumab for the treatment of hospitalized, non-mechanically-ventilated adult patients with hypoxia and severe COVID-19 pneumonia/hyperinflammation.
A total of 582 patients in the Phase III portion of the trial were randomized in a 1:1:1 ratio to receive a single intravenous dose of mavrilimumab 10 mg/kg, 6 mg/kg, or placebo. The Phase III portion of the trial did not meet its primary efficacy endpoint of proportion of patients alive and free of mechanical ventilation at Day 29.
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