Sanofi announces primary endpoint was met in its Phase 2b study of amlitelimab

The primary endpoint was met in a Phase 2b study, STREAM-AD, of amlitelimab in adults with moderate-to-severe atopic dermatitis whose disease cannot be adequately controlled with topical medications or for whom topical medications are not a recommended treatment approach. In this dose-ranging study, treatment with amlitelimab resulted in statistically significant improvements in average Eczema Area and Severity Index score from baseline at 16 weeks compared to placebo for all four subcutaneous doses that were studied. There were also improvements in key secondary outcome measures and continued improvements were observed through week 24 in primary and key secondary outcomes. Amlitelimab was well-tolerated in the study across all dose arms and no new safety concerns were identified. Naimish Patel, M.D., Head of Global Development, Immunology and Inflammation, Sanofi, “While we have made significant strides in the treatment of atopic dermatitis, there are patients who are still in need of new options. We believe that the results from this Phase 2b study with amlitelimab support our perspective that targeting OX40-Ligand has the potential to provide a first and best-in-class treatment option that addresses type 2 and non-type 2 inflammation to meet the individual needs of people living with atopic dermatitis and other chronic inflammatory diseases.”