The primary endpoint was met in a Phase IIb study (STREAM-AD) of amlitelimab (formerly KY1005) 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.
According to French pharma major Sanofi (Euronext: SAN), in this dose-ranging study, treatment with amlitelimab resulted in statistically-significant improvements in average Eczema Area and Severity Index (EASI) 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. Biomarker results support an effect on both type 2 and non-type 2 pathways.
Amlitelimab was well-tolerated in the study across all dose arms and no new safety concerns were identified.
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