Overview
- In the SHORE study (n=596), amlitelimab plus topical corticosteroids met primary and key secondary endpoints, with vIGA‑AD 0/1 rates of 28.7%–32.9% versus 16.8% on placebo and EASI‑75 rates of 46.8%–50.9% versus about 32.3%–34.2%.
- In COAST 2 (n=547) monotherapy, the US estimand met the primary endpoint at week 24 (25.3%–25.7% vs 14.8% for placebo), but co‑primary endpoints were not statistically significant in the EU estimand and a key secondary vIGA‑AD measure missed significance in some US analyses.
- Sanofi said amlitelimab was well tolerated in both studies, with a safety profile consistent with earlier data in patients aged 12 and older.
- The company plans global regulatory submissions in the second half of 2026 and expects additional phase 3 readouts from AQUA and ESTUARY in the same period, with phase 2 ATLANTIS data indicating progressive efficacy through week 52.
- Amlitelimab, an OX40‑ligand–targeting antibody positioned as a potential successor to Dupixent, advances as a separate FDA complete response letter for tolebrutinib this month highlights regulatory scrutiny of Sanofi’s pipeline.