Sanofi has announced that its amlitelimab has shown positive results in the treatment of patients 12 years and older with atopic dermatitis (AD).
Positive results from the COAST 1 study were announced in September 2025. Sanofi has now released study data from the global phase 2 SHORE and COAST 2 studies of amlitelimab, a non-T cell depleting monoclonal antibody designed to target OX40-ligand (OX40L).
Both the SHORE and COAST 2 studies evaluated the use of amlitelimab as a treatment for patients over the age of 12 with moderate to severe AD. The treatment was given either every four weeks or every 12 weeks. The SHORE study found that both doses, in conjunction with medium-potency background topical corticosteroids (TCS) with or without topical calcineurin inhibitors (TCI), met primary and key secondary endpoints compared with placebo plus TCS with or without TCI.
The COAST 2 study found that both doses of amlitelimab as a monotherapy met the study’s primary endpoint at week 24.
The treatment presented a favourable safety and tolerability profile in both studies. Rates of treatment-emergent adverse events (TEAEs), including those that resulted in discontinuation of treatment, were consistent between the amlitelimab treatment arms and the placebo arms of the studies.
Sanofi has also highlighted preliminary analysis from the ongoing phase 2 ATLANTIS study. This analysis has suggested progressive improvements in skin clearance and disease severity with four-weekly dosing of amlitelimab. The improvements lasted into week 52 of observation, and the treatment continued to be well-tolerated over this period.
Houman Ashrafian, Executive Vice President, Head of Research & Development at Sanofi, said: “Importantly, these results validate amlitelimab’s novel mechanism of action to block OX40L without T-cell depletion and its promise to normalise the immune system over time. The totality of data seen to date reinforces our confidence in amlitelimab’s potential to deliver both [12-week] dosing from the start and progressive efficacy through week 52.”