Sanofi has announced positive results from three Phase 3 trials of amlitelimab—COAST 1, COAST 2, and SHORE—presented at the 2026 American Academy of Dermatology (AAD) Annual Meeting in Denver, Colorado.
The healthcare group noted that this fully human, non-T-cell depleting monoclonal antibody, which selectively targets the OX40 ligand (OX40L), was evaluated for the treatment of moderate-to-severe atopic dermatitis (AD).
Administered as both monotherapy and in combination with topical therapies, the drug demonstrated significant improvements in skin clearance and disease severity compared to placebo in patients aged 12 and older.
Across all three studies, amlitelimab administered every 4 or 12 weeks showed a progressive increase in efficacy, with no signs of a plateau at week 24 across all endpoints. Furthermore, the data support the potential for a 12-week dosing regimen from the outset of treatment.
Results from ESTUARY, a Phase 3 extension study evaluating a once-every-12-weeks maintenance dose and long-term safety, are expected in the second half of 2026.
Sanofi is the largest European pharmaceutical group. Net sales by family of products break down as follows:
- pharmaceutical products (81.8%): prescription drugs for the treatment of multiple sclerosis, neurological diseases, inflammatory diseases, autoimmune diseases, rare diseases, cancers and rare hematological diseases;
- human vaccines (18.2%): pediatric vaccines, vaccines for flu, meningitis, and polio, booster vaccines, and vaccines for travelers and endemic areas.
At the end of 2025, the group had 37 production sites worldwide.
Net sales are distributed geographically as follows: France (3.9%), Europe (17.1%), the United States (50.8%), China (6%) and other (22.2%).
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