Sanofi: amlitelimab significantly improved signs and symptoms of moderate-to-severe atopic dermatitis

Positive results from a Phase 2b study (STREAM-AD) showed that amlitelimab significantly improved signs and symptoms of moderate-to-severe atopic dermatitis in adults whose disease cannot be adequately controlled with topical medications or for whom topical medications are not a recommended treatment approach.

These detailed results were presented today as part of a late-breaking session at the European Academy of Dermatology and Venereology (EADV) 2023 Congress in Berlin. The Phase 3 program for amlitelimab in atopic dermatitis is on track to start in the first half of 2024. This program is part of Sanofi’s immunology strategy built around exploring disruptive mechanisms of action designed to deliver first and best-in-class treatments for people living with chronic inflammatory diseases.

In this dose-ranging study, subcutaneous treatment with amlitelimab resulted in statistically significant improvements in the primary endpoint of percent change in Eczema Area and Severity Index (EASI) score from baseline at 16 weeks compared to placebo for all four doses that were studied. Among these, patients treated with amlitelimab 250 mg Q4W with 500 mg loading dose (LD) had the numerically highest response versus placebo, showing a 61.5% reduction in EASI from baseline at week 16 (P<0.0001) and a 64.4% reduction at week 24 (P<0.0001) vs. 29.4% at week 16 and 27.6% at week 24 for placebo.

Professor Stephan Weidinger, Director, Professor, Chair of Department of Dermatology and Allergy, University Hospital Schleswig-Holstein, said that these results are exciting news for patients with moderate-to-severe atopic dermatitis who continue to suffer from symptoms including persistent itch and skin lesions, despite available treatment options. “Across all four doses studied, we saw consistent improvements in important signs and symptoms of the disease with an unremarkable safety profile. These data also add to the growing body of evidence that targeting OX40-Ligand potentially stops the inflammatory cascade across multiple pathways resulting in significant benefit for patients,” Weidinger said.