On Friday, Sanofi SA (NASDAQ:SNY) shared data from two global phase 3 studies of amlitelimab, a fully human non-T cell depleting monoclonal antibody that selectively targets OX40-ligand (OX40L) to treat atopic dermatitis.
Amlitelimab is considered a potential successor to the blockbuster eczema drug Dupixent.
The company said the data delivered a robust body of evidence that supports amlitelimab's potential in the treatment of patients 12 years and older with moderate-to-severe atopic dermatitis (AD).
Data
In these two phase 3 studies, amlitelimab was well-tolerated, and the safety profile was consistent with previously reported data.
In September 2025, Sanofi’s COAST 1 phase 3 study of amlitelimab failed to match investor expectations, though the trial met all primary and key secondary endpoints, demonstrating statistically significant and clinically meaningful skin clearance and disease severity compared to placebo.
For SHORE and COAST 2 phase 3 studies, key endpoints were measured at Week 24 in patients aged 12 years and older with moderate-to-severe AD who received amlitelimab either every four weeks (Q4W) or every 12 weeks (Q12W).
The studies assessed EASI 75, a proportion of patients reaching a 75% or greater improvement in the eczema area and severity index, and (vIGA-AD) of 0 (clear) or 1 (almost clear).
SHORE Study in 596 Patients
Amlitelimab, dosed in conjunction with medium-potency background topical corticosteroids (TCS) with or without topical calcineurin inhibitors, met all primary and key secondary endpoints compared to placebo plus TCS.
The company noted that significantly more patients receiving amlitelimab Q4W and Q12W achieved clear or almost clear skin compared with placebo participants (vIGA-AD 0/1: 28.7%–32.9% vs. 16.8% and EASI-75: 46.8%–50.9% vs ~32.3%–34.2%).
COAST 2 Study In 547 Patients
The study met the primary endpoint at week 24 in the US estimand, with non-responder imputation rates of 25.3% and 25.7% for amlitelimab monotherapy Q4W and Q12W, respectively, versus 14.8% for placebo.
But, the study did not achieve statistical significance for the co-primary endpoints of proportion of patients achieving vIGA-AD 0/1 and EASI-75 compared to placebo in the EU estimand.
Additionally, a key secondary endpoint of vIGA-AD 0/1 with barely perceptible erythema also missed significance for US estimands.
Sanofi also shared preliminary analysis of the ATLANTIS phase 2 study that indicated that amlitelimab dosed Q4W progressively improved skin clearance and disease severity beyond Week 24 to Week 52 in 591 patients.
Upcoming Catalysts
Two additional phase 3 studies, AQUA and ESTUARY, are anticipated to report results in the second half of 2026. Global regulatory submissions are planned for the second half of 2026.
Earlier in January, the U.S. Food and Drug Administration (FDA) issued a complete response letter (CRL) for Sanofi’s new drug application of tolebrutinib to treat non-relapsing secondary progressive multiple sclerosis (nrSPMS) in adult patients.
The FDA publicly shared the complete response letter, citing both efficacy and safety concerns.
SNY Price Action: Sanofi shares were down 0.37% at $46.33 during premarket trading on Friday, according to Benzinga Pro data.
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