Sanofi SA SNY says its Phase 2b study (STREAM-AD) of amlitelimab for adults with moderate-to-severe atopic dermatitis, who cannot adequately manage their condition with topical medications, has met its primary endpoint.
This represents the 5th positive outcome for Sanofi's pipeline since the start of 2023.
Amlitelimab displayed statistically significant improvements in signs and symptoms of moderate-to-severe atopic dermatitis in adults.
Also Read: Sanofi's $3B Acquisition Of Provention Bio Hits Regulatory Roadblock: FTC Requests More Information.
The treatment with amlitelimab led to statistically significant improvements in the average Eczema Area and Severity Index (EASI) score from baseline at 16 weeks compared to placebo for all four subcutaneous doses studied.
Improvements were also seen in key secondary endpoints at 16 weeks.
Both primary and key secondary outcomes saw continued improvements through week 24.
Biomarker results suggest an impact on both type 2 and non-type 2 pathways.
Amlitelimab was well-tolerated across all dose arms in the study, and no new safety issues were detected.
Amlitelimab is a fully human non-depleting monoclonal antibody that binds to OX40-Ligands.
Detailed efficacy and safety results from this trial will be presented in a future scientific forum.
Price Action: SNY shares are down 0.34% at $53.30 premarket on the last check Tuesday.
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