Sanofi unveiled promising outcomes from its Phase 2b trial, STREAM-AD, during the European Academy of Dermatology and Venereology (EADV) 2023 Congress. The study assessed amlitelimab, a novel treatment for moderate-to-severe atopic dermatitis in adults with uncontrolled symptoms. The results were highly encouraging, showcasing the drug's potential to significantly enhance the lives of individuals for whom topical treatments are ineffective or not recommended.

In the dose-ranging trial, patients treated with subcutaneous amlitelimab displayed substantial improvements compared to a placebo, with statistically significant reductions in the Eczema Area and Severity Index (EASI) score over 16 weeks. Notably, amlitelimab 250 mg with a 500 mg loading dose demonstrated the most significant response, with a 61.5% reduction in EASI from baseline at week 16 and a 64.4% reduction at week 24.
The Chair of the Department of Dermatology and Allergy at the University Hospital Schleswig-Holstein, expressed enthusiasm about these findings. He emphasized that these results bring hope to patients suffering from persistent itch and skin lesions despite available treatments. The study also demonstrated a consistently positive impact on various aspects of the disease and maintained a favorable safety profile.
Amlitelimab achieved numerous secondary endpoints, such as improvements in the Investigator Global Assessment response, a 75% reduction in EASI, and a reduction in pruritus (itching). Amlitelimab's 250 mg with a loading dose particularly stood out, with 45.5% of patients achieving clear or almost clear skin (IGA 0/1) at week 24 and 54.5% attaining a 75% reduction in EASI.

Additionally, amlitelimab effectively reduced biomarkers associated with atopic dermatitis, including Th2-related IL-13 and TARC, Th17/Th22-related IL-17A and IL-22, and blood eosinophil counts. This reduction was observed as early as week 4 in the 250 mg with a loading dose arm.
Houman Ashrafian, Global Head of Research & Development at Sanofi, highlighted the significance of these results and their potential to transform the treatment landscape for atopic dermatitis. Sanofi's plans to initiate a Phase 3 development program in the first half of 2024 underscores their dedication to addressing this chronic condition.
Amlitelimab demonstrated an acceptable safety profile throughout the trial, with no new safety concerns identified. It is a fully human non-depleting monoclonal antibody targeting OX40-Ligand, which has the potential to become a first-in-class treatment for various immune-mediated and inflammatory disorders, including atopic dermatitis and asthma. It's important to note that amlitelimab is still under clinical investigation, and its safety and efficacy have not been evaluated by any regulatory authority.
Source:
Press Release: Late-breaking amlitelimab Phase 2b data presented at EADV show potential best-in-class profile in atopic dermatitis. (n.d.). Sanofi.com. Retrieved October 15, 2023