Press Release: Sanofi's amlitelimab confirms its potential in atopic dermatitis

Core Insights - Amlitelimab shows promising results in treating moderate-to-severe atopic dermatitis (AD) in patients aged 12 years and older, supported by positive outcomes from two phase 3 studies, SHORE and COAST 2 [1][2] Study Results - In the SHORE study, amlitelimab met all primary and key secondary endpoints at Week 24, demonstrating significant efficacy compared to placebo [3][5] - The primary endpoint for SHORE was the proportion of patients achieving a validated investigator global assessment scale for AD (vIGA-AD) of 0 or 1, with a reduction from baseline score of ≥2 points [2][4] - In the COAST 2 study, amlitelimab met the primary endpoint for the US and US reference countries but did not achieve statistical significance for co-primary endpoints in the EU and EU reference countries [5][8] Efficacy Data - In the SHORE study, the proportion of patients achieving vIGA-AD 0/1 was 28.7% for Q4W dosing and 32.3% for Q12W dosing, both statistically significant [4] - The EASI-75 response rates were 48.1% for Q4W and 46.8% for Q12W, also showing statistical significance [4] - In the COAST 2 study, the vIGA-AD 0/1 rates were 25.3% for Q4W and 25.7% for Q12W, with EASI-75 rates of 41.8% and 40.5% respectively [9] Safety Profile - Amlitelimab was well-tolerated in both studies, with treatment-emergent adverse events (TEAEs) similar to placebo [12][13] - Common TEAEs in the SHORE study included nasopharyngitis (9.5% vs 12.5% in placebo) and upper respiratory tract infection (7.9% vs 4.4%) [12] - In the COAST 2 study, the most common TEAEs were nasopharyngitis (5.9% vs 7.4% in placebo) and upper respiratory tract infection (4.8% vs 4.0%) [13] Future Directions - Sanofi plans to move forward with global regulatory submissions for amlitelimab based on the totality of data from the studies [5] - Preliminary analysis from the ATLANTIS phase 2 study indicates continued improvements in skin clearance and disease severity beyond Week 24 [14][16] - Additional phase 3 studies, AQUA and ESTUARY, are expected to report results in H2 2026 [18]