Sanofi has announced that its investigational therapy amlitelimab has met all primary and key secondary endpoints in the global COAST 1 phase-III study, marking an important milestone in the treatment of moderate-to-severe atopic dermatitis in adults and adolescents aged 12 years and older.

The trial evaluated amlitelimab, administered either every four weeks or every 12 weeks, against a placebo. Results at Week 24 showed clinically meaningful improvements in skin clearance and disease severity, with efficacy continuing to increase beyond that point. Importantly, patients receiving amlitelimab experienced meaningful relief with a reduced dosing schedule, highlighting the therapy’s potential to transform treatment standards for this chronic condition.

Safety was also a key outcome of the study. According to Sanofi, amlitelimab was well-tolerated, and no new safety concerns emerged during the trial period. This reinforces its profile as a promising candidate for patients who may struggle with the limitations of current therapies.

Amlitelimab is being studied as part of Sanofi’s OCEANA clinical development programme, which includes four additional ongoing phase-III studies. These trials are designed to build on the COAST 1 findings and provide a comprehensive understanding of amlitelimab’s role in long-term disease management. Further results are expected to be released through 2026.

“These positive first phase-III results of Amlitelimab reinforce the potential of targeting the OX40-ligand to normalise the overactive immune system, without depleting T cells.” Amlitelimab may represent a significant advance in the treatment of atopic dermatitis with clinically meaningful and progressively increasing efficacy, with the potential of dosing only four times per year. These promising data, seen in a study population that more closely resembles today’s diverse patient landscape, including a substantial proportion previously treated with advanced therapies, support our ambition to deliver a differentiated medicine. We look forward to share additional phase-III results from the OCEANA clinical development programme.”