Sanofi’s Amlitelimab Shows Mixed Phase 3 Results in Eczema Trials, Clouds Blockbuster Hopes but Advances to Regulatory Filings

Sanofi's amlitelimab met primary and secondary endpoints in COAST 1 Phase 3 trial in September 2025, showing efficacy in skin clearance for moderate-to-severe atopic dermatitis.1

In COAST 2, amlitelimab met the US primary endpoint (vIGA-AD 0/1) with 25.3% (monthly) and 25.7% (quarterly) vs placebo, but missed EU co-primary endpoints due to higher placebo response.235

SHORE trial (with topical therapies) met all primary (vIGA-AD 0/1, EASI-75) and key secondary endpoints for both dosing regimens at Week 24 under US and EU analyses.456

ATLANTIS Phase 2 data showed deepening responses over time, with vIGA-AD 0/1 rising from 35.4% at Week 24 to 50.3% at Week 52, and EASI-75 from 62.9% to 76.5%.369

Despite mixed COAST 2 results falling short of Dupixent benchmarks, Sanofi plans global regulatory submissions based on totality of data, with more trials like ESTUARY due H2 2026.3457

Sources:

1. https://www.clinicaltrialsarena.com/analyst-comment/jpm26-sanofi-clinical-trials-amlitelimab/

2. https://www.clinicaltrialsarena.com/news/sanofi-amlitelimab-phase-iii-coast2-shore-atopic-dermatitis/

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

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

5. https://www.stocktitan.net/sec-filings/SNY/6-k-sanofi-current-report-foreign-issuer-b58af32b5a5e.html

6. https://www.contemporarypediatrics.com/view/phase-3-trials-support-amlitelimab-efficacy-for-atopic-dermatitis-in-patients-12-years-and-older

7. https://www.biopharmadive.com/news/sanofi-amlitelimab-eczema-atopic-dermatitis-drug-results/810353/

9. https://www.empr.com/news/phase-3-trials-support-amlitelimab-for-moderate-to-severe-atopic-dermatitis/