Sanofi's amlitelimab, a fully human non-T cell-depleting monoclonal antibody targeting OX40L, delivered strong Phase 3 results in moderate-to-severe atopic dermatitis (AD) for patients 12+.
In the SHORE study (with topical therapies), it met all primary and key secondary endpoints at Week 24. Benefits emerged as early as Week 2, with efficacy increasing over time.
The COAST 2 study (monotherapy) supported efficacy but missed one co-primary endpoint tied to perceptible erythema.
Building on positive COAST 1 data, amlitelimab showed good tolerability (similar to placebo; common AEs: nasopharyngitis, upper respiratory infections) and offers flexible every-4-week or every-12-week dosing after loading - potentially easing the burden of current monthly biologics.
There is ongoing anticipation for OX40/OX40L inhibitors (e.g., rocatinlimab, amlitelimab) as a new therapeutic class for AD.
There is a research shift toward upstream immune modulation (e.g., T-cell targeting via OX40L or ITK) for potentially more durable or convenient AD control, with several candidates advancing toward regulatory filings.
https://www.sanofi.com/en/media-room/press-releases/2026/2026-01-23-06-00-00-3224400