Sanofi presents new positive results from amlitelimab phase 3 studies in atopic dermatitis

Sanofi presented positive results from three phase 3 studies of amlitelimab in moderate to severe atopic dermatitis at the 2026 American Academy of Dermatology Annual Meeting. The COAST 1, COAST 2 and SHORE studies were presented in a late breaking research session in Denver, Colorado. The fully human non T cell depleting monoclonal antibody selectively targets OX40 ligand and was evaluated as monotherapy and in combination with topical therapies in patients aged 12 years and older. Across the studies amlitelimab dosed every four weeks or every 12 weeks showed progressively increasing efficacy with no evidence of plateau at week 24. Improvements in skin clearance and disease severity were observed compared to placebo. Amlitelimab was generally well tolerated. Amlitelimab met the primary endpoint in COAST 1 and COAST 2. In the SHORE study the drug in combination with topical corticosteroids with or without topical calcineurin inhibitors demonstrated significant improvements in atopic dermatitis clinical signs and symptoms versus placebo at week 24. The safety profile of amlitelimab was consistent with previously reported data. The most common treatment emergent adverse events were nasopharyngitis and upper respiratory tract infection. Malignancy rates were low and generally similar between treatment and placebo groups. Houman Ashrafian, executive vice president and head of research and development at Sanofi, said the totality of data reinforce the progressive improvement in efficacy seen with amlitelimab over the course of treatment and the potential for every 12 week dosing from the start. Eric Simpson, professor of dermatology and director of clinical research at Oregon Health and Science University, said these data show that amlitelimab delivers potentially progressive efficacy over time and further illustrate the potential of non T cell depleting OX40 ligand inhibition to help reduce disease severity and burdensome symptoms with less frequent dosing.