Sanofi Reports Positive but Mixed Phase 3 Results for Amlitelimab in Atopic Dermatitis with OX40L Targeting and Kaposi's Sarcoma Case

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Sanofi announced positive Phase 3 results from COAST 1, COAST 2, and SHORE studies for amlitelimab, an anti-OX40 ligand antibody, showing improvements in skin clearance and itch reduction in moderate-to-severe atopic dermatitis patients aged 12+ compared to placebo.123

COAST 1 met primary and key secondary endpoints (vIGA-AD 0/1, EASI-75, PP-NRS ≥4); COAST 2 met primary but mixed secondaries (EASI-75 and PP-NRS significant, vIGA-AD not); SHORE met all endpoints with topical therapies.235

Data indicate progressive efficacy without plateau at Week 24, supporting Q12W dosing potential; long-term Atlantis Phase 2 data showed continued improvements to Week 52.2356

Results described as mixed by some analysts, falling short of Dupixent benchmarks despite meeting endpoints.5

One patient with risk factors developed cutaneous Kaposi's sarcoma in Atlantis study, stopped treatment, and is recovering; well-tolerated overall.5

Sources:

1. https://www.marketscreener.com/news/sanofi-presents-new-results-from-amlitelimab-phase-3-studies-in-atopic-dermatitis-ce7e51d8dc8ef626

2. https://www.nasdaq.com/press-release/press-release-aad-new-results-sanofis-amlitelimab-phase-3-studies-atopic-dermatitis

3. https://www.sanofi.com/en/media-room/press-releases/2026/2026-03-28-15-00-00-3264184

5. https://www.fiercebiotech.com/biotech/sanofi-posts-mixed-phase-3-data-key-eczema-prospect-plans-global-filings

6. https://www.sanofi.com/en/media-room/press-releases/2026/2026-01-23-06-00-00-3224400