This is a Phase 2, randomized, placebo-controlled, double-blind, proof-of-concept study of
intranasal foralumab in hospitalized subjects with severe COVID-19 and pulmonary
inflammation.
Foralumab is a fully human second generation anti-CD3 mAb with a modified Fc unit (two amino
acid substitutions) composed of 2 heavy chains with an immunoglobulin (Ig) G1constant region
and 2 light chains with a kappa constant region.
In a separate Phase 2 randomized, controlled, pilot trial conducted to assess safety,
tolerability, and efficacy in 39 patients with mild to moderate COVID-19 in Brazil, showed
that intranasal foralumab may be of benefit in modulating immune reactivity and in reducing
pulmonary inflammation. Importantly, intranasal administration of foralumab was well
tolerated with no clinically significant changes in blood cell counts (including blood
lymphocytes), no evidence of hypersensitivity, and no serious adverse events (SAEs) were
reported in the study.