Sanofi Reports Positive Phase 3 Results For Amlitelimab In Atopic Dermatitis

(RTTNews) - Sanofi SA (SNY, SNYNF,SAN.PA) announced encouraging results from three Phase 3 clinical trials—COAST 1, COAST 2, and SHORE—evaluating amlitelimab, a fully human non-T cell depleting monoclonal antibody that selectively targets OX40-ligand (OX40L). The studies, presented at the 2026 American Academy of Dermatology (AAD) Annual Meeting in Denver, demonstrated significant improvements in skin clearance and disease severity in patients aged 12 years and older with moderate-to-severe atopic dermatitis (AD).

In both COAST 1 and COAST 2, amlitelimab met the primary endpoint of achieving a validated investigator global assessment scale for AD (vIGA-AD) score of 0 (clear) or 1 (almost clear) with a =2-point reduction from baseline. COAST 1 also showed statistically significant improvements in key secondary endpoints, including vIGA-AD 0/1 with barely perceptible erythema (BPE), EASI-75 (=75% improvement in eczema area and severity index), and a =4-point reduction in peak pruritus-numerical rating scale (PP-NRS). In COAST 2, EASI-75 and PP-NRS=4 reached nominal significance, while vIGA-AD 0/1 with BPE did not achieve statistical significance.

The SHORE study evaluated amlitelimab in combination with topical corticosteroids (TCS) and, in some cases, topical calcineurin inhibitors (TCI). Both dosing regimens—every four weeks (Q4W) and every 12 weeks (Q12W)—produced significant improvements in AD signs and symptoms compared with placebo across primary and key secondary endpoints at Week 24.

Across all three studies, amlitelimab was generally well-tolerated, with a safety profile consistent with previously reported data.

Looking ahead, results from ESTUARY, a Phase 3 extension study assessing Q12W maintenance dosing and long-term safety, are expected in the second half of 2026. This will provide further insights into amlitelimab's potential as a durable treatment option for patients with moderate-to-severe atopic dermatitis.

SNY closed Friday's regular trading at $46.78 up $0.18 or 0.39%.

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