Sanofi has reported positive Phase 3 trial results for amlitelimab, a monoclonal antibody targeting OX40-ligand, in treating moderate-to-severe atopic dermatitis. The data were presented in a late-breaking session at the American Academy of Dermatology Annual Meeting in Denver.
Three studies – COAST 1, COAST 2, and SHORE – demonstrated progressive efficacy improvements with both monthly and quarterly dosing schedules compared to placebo in patients aged 12 and older. Amlitelimab showed effectiveness both as monotherapy and in combination with topical treatments. Safety profiles remained consistent with prior data, though two Kaposi’s sarcoma cases were reported across all development programs among more than 3,778 exposed patients.
The quarterly dosing option is a notable differentiator in the atopic dermatitis treatment landscape, potentially offering patients a less frequent injection schedule. Additional studies including ATLANTIS and ESTUARY are continuing to evaluate the drug across different patient populations and treatment settings.