Sanofi: Positive Phase 3 Results for New Eczema Treatment
On Friday, March 28, Sanofi unveiled positive results from three Phase 3 studies assessing amlitelimab, a monoclonal antibody, for the treatment of moderate to severe atopic dermatitis. The data were presented during a last-minute oral communication at the annual congress of the American Academy of Dermatology in Denver.
Clinical Study Outcomes
The three clinical studies—COAST 1, COAST 2, and SHORE—evaluated amlitelimab administered either as monotherapy or in combination with topical treatments in patients aged 12 and older. The results demonstrated improvements in skin clearance and disease severity compared to placebo. The drug was tested under two dosing regimens: an injection every four weeks or every twelve weeks. Primary and key secondary endpoints were measured at week 24. In the COAST 1 and COAST 2 studies, amlitelimab met the primary endpoint. In the SHORE study, combined with topical corticosteroids with or without topical calcineurin inhibitors, the drug showed significant improvements in clinical signs and symptoms of atopic dermatitis.
Safety and Tolerability
Amlitelimab was generally well tolerated across the three studies. The most commonly observed adverse events included rhinopharyngitis, atopic dermatitis, and upper respiratory tract infections. The incidence of pyrexia, chills, and headaches was low. Rates of malignant tumors were low and generally similar between the amlitelimab and placebo groups. No events of severe injection site reactions or serious gastrointestinal ulceration were observed. In total, two cases of Kaposi's sarcoma were reported among 3,778 patients exposed to amlitelimab across all indications, both patients having known risk factors. The drug remains under clinical development; its safety and efficacy have not been evaluated by any regulatory authority. Results from the ESTUARY study, a Phase 3 extension study assessing maintenance dose and long-term safety, are expected in the second half of 2026.
