Sanofi has strengthened the clinical case for amlitelimab, its investigational monoclonal antibody targeting OX40-ligand, following positive results from two global phase 3 studies—SHORE and COAST 2—in patients aged 12 years and older with moderate-to-severe atopic dermatitis (AD).
Based on the totality of data across its clinical programme, the company plans to proceed with global regulatory submissions in the second half of 2026.
In the SHORE phase 3 study, amlitelimab, used in combination with topical therapies, met all primary and key secondary endpoints at Week 24 across both US and EU statistical frameworks. The treatment showed progressively increasing efficacy over time, with some patients demonstrating improvement as early as Week 2. Both every-four-week (Q4W) and every-12-week (Q12W) dosing regimens achieved statistically significant improvements in skin clearance and disease severity compared with placebo.
The COAST 2 phase 3 study, which evaluated amlitelimab as monotherapy, met its primary endpoint for the US and US reference countries, demonstrating a statistically significant proportion of patients achieving clear or almost clear skin at Week 24. While key endpoints were not met under the EU statistical framework, the study confirmed the viability of Q12W dosing from the start of treatment, supporting earlier findings from the COAST 1 trial.
Across both phase 3 studies, amlitelimab was generally well tolerated, with safety profiles consistent with previously reported data. Rates of treatment-emergent adverse events, serious adverse events, and treatment discontinuations were comparable to placebo.
Additional support for amlitelimab’s long-term potential comes from a preliminary analysis of the ongoing ATLANTIS phase 2 open-label study, which showed continued and progressive improvements in skin clearance and disease severity through Week 52, with no evidence of a treatment plateau. The data further highlight OX40-ligand inhibition as a promising new immunological mechanism in atopic dermatitis.
Sanofi noted that results from SHORE, COAST 1, COAST 2, and ATLANTIS will be presented at upcoming medical congresses. Two further phase 3 studies—AQUA and ESTUARY—are expected to report results in the second half of 2026. Amlitelimab remains an investigational therapy and has not yet been evaluated by regulatory authorities for safety or efficacy.
