PARIS (dpa-AFX) - Sanofi SA's (SAN.PA, SNYNF, SNY) investigational therapy, amlitelimab, has achieved a significant milestone in the COAST 1 phase 3 clinical trial, meeting all primary and key secondary endpoints in adults and adolescents with moderate-to-severe atopic dermatitis. Administered either every four weeks or every 12 weeks, amlitelimab demonstrated statistically significant and clinically meaningful improvements in skin clearance and disease severity compared to placebo at Week 24, the company said in a statement.
Notably, the treatment's efficacy continued to increase throughout the study period, suggesting a durable and progressive therapeutic benefit.
These results underscore amlitelimab's potential to become the first and only atopic dermatitis treatment with a dosing schedule as infrequent as four times per year, offering a more convenient option for patients.
According the company, the promising data also highlighted the drug's ability to normalize immune system activity by targeting the OX40-ligand pathway without depleting T cells. Further phase 3 studies within the broader OCEANA clinical program are expected to provide deeper insights into amlitelimab's long-term efficacy, safety profile, and its potential for sustained benefits even after treatment cessation across diverse patient populations.
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