Press Release: Sanofi's amlitelimab met all primary and key secondary endpoints in the COAST 1 phase 3 study in adults and adolescents with atopic dermatitis

Core Insights - Amlitelimab, a monoclonal antibody targeting OX40-ligand, met all primary and key secondary endpoints in the COAST 1 phase 3 study for atopic dermatitis, showing significant skin clearance and reduced disease severity compared to placebo at Week 24 [1][2][6] - The study demonstrated that amlitelimab can be administered every four weeks or every twelve weeks, with a potential for only four doses per year, indicating a significant advancement in treatment options for atopic dermatitis [2][6] - Amlitelimab was well-tolerated, with no new safety concerns identified, and the most common treatment-emergent adverse events were more prevalent in the placebo group [7] Study Details - The COAST 1 study was a randomized, double-blind, placebo-controlled trial involving 601 participants aged 12 years and older with moderate-to-severe atopic dermatitis, conducted across 15 countries [9] - Key endpoints included the proportion of patients achieving a validated investigator global assessment scale for AD (vIGA-AD) of 0 or 1 and a reduction from baseline score of ≥2 points, as well as a 75% or greater improvement in the eczema area and severity index total score (EASI-75) [2][3][9] - Results showed that 21.1% and 22.5% of patients on Q4W and Q12W dosing achieved vIGA-AD 0/1, respectively, compared to 9.2% in the placebo group, with p-values indicating statistical significance [3] Efficacy and Safety - Amlitelimab demonstrated progressively increasing efficacy throughout the treatment period, with significant improvements in both skin clearance and disease severity compared to placebo [6][8] - The study's key secondary endpoints were also achieved, including a reduction in peak pruritus and achieving vIGA-AD 0/1 with minimal erythema [5][6] - The safety profile was favorable, with similar rates of treatment-emergent adverse events between amlitelimab and placebo groups, and mild injection site reactions were the most common adverse events [7] Future Outlook - Additional phase 3 data from the OCEANA clinical development program, which includes COAST 1 and four other studies, is expected to provide further insights into amlitelimab's efficacy and safety [8] - The results from these studies will form the basis for potential global regulatory submissions, with ongoing investigations into the long-term maintenance treatment and off-treatment efficacy [8][10]