Sanofi's Amlitelimab: A Groundbreaking Treatment for Atopic Dermatitis

Sanofi's amlitelimab has achieved all primary and key secondary endpoints in a Phase 3 clinical trial for moderate-to-severe atopic dermatitis. The treatment demonstrated significant improvements in skin clearance and disease severity, with efficacy continuing to increase throughout the study period. Amlitelimab may become the first treatment for atopic dermatitis with a dosing schedule as infrequent as four times per year. Further studies are planned to provide deeper insights into its long-term efficacy and safety profile.

Sanofi's amlitelimab has achieved all primary and key secondary endpoints in the COAST 1 phase 3 clinical trial, demonstrating significant improvements in skin clearance and disease severity for patients with moderate-to-severe atopic dermatitis (AD). The treatment, administered either every four weeks (Q4W) or every 12 weeks (Q12W), showed clinically meaningful and progressively increasing efficacy compared to placebo [1].

The trial, which enrolled adults and adolescents aged 12 years and older, found that amlitelimab met all primary and key secondary endpoints at Week 24. For the US and US reference countries, the primary endpoint was the proportion of patients with a validated investigator global assessment scale for AD (vIGA-AD) of 0 (clear) or 1 (almost clear) and a reduction from baseline score of ≥2 points. In the EU, EU reference countries, and Japan, the co-primary endpoints included the proportion of patients with vIGA-AD 0/1 and a reduction from baseline score of ≥2 points, along with the proportion of patients reaching a 75% or greater improvement in the eczema area and severity index total score (EASI-75).

The results indicate that amlitelimab could become the first treatment for AD with a dosing schedule as infrequent as four times per year. This represents a significant advancement in the treatment of AD, with potential long-term benefits and reduced treatment burden for patients.

Further phase 3 data from the OCEANA clinical development program will provide a comprehensive understanding of amlitelimab’s efficacy and safety profile, including the role of long-term maintenance treatment and the potential for off-treatment efficacy across diverse treatment populations.

References:
[1] https://www.nasdaq.com/press-release/press-release-sanofis-amlitelimab-met-all-primary-and-key-secondary-endpoints-coast-2