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Press Release: Late-breaking amlitelimab Phase 2b data presented at EADV show potential best-in-class profile in atopic dermatitis

Published: 2023-10-13 14:00:00 ET
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Late-breaking amlitelimab Phase 2b data presented at EADV show potential best-in-class profile in atopic dermatitis

  • Patients treated with amlitelimab experienced up to 61.5% improvement in average Eczema Area and Severity Index (EASI) score from baseline at week 16, the primary endpoint, with continued improvement seen through 24 weeks
  • Clinically meaningful improvements were seen in all key secondary endpoints at week 16 with continued improvements through week 24, including for IGA 0/1 where patients on the highest dose experienced 22.1% improvement at week 16 which increased to 45.5% by week 24
  • Amlitelimab was well-tolerated and no fever/chills, oral ulcers or imbalances with conjunctivitis were observed across doses
  • Amlitelimab has a unique non-depleting mechanism of action targeting OX40-Ligand with the potential to durably restore immune balance, sustained effect and infrequent dosing

Paris, October 13, 2023. 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