French healthcare company Sanofi S.A. (Euronext Paris:SAN) (Nasdaq:SNY) said on Friday that it will discontinue the clinical development of amlitelimab, an OX40-ligand monoclonal antibody, for moderate-to-severe atopic dermatitis (AD) and will not submit the therapy for global regulatory review following an ongoing strategic assessment of its pipeline.
The company said the totality of efficacy and safety data does not support further development in AD. Although the ESTUARY phase 3 long-term extension study showed long-term maintenance of clinical response without relapse in patients aged 12 years and older with moderate-to-severe AD and an emerging safety profile that builds on previous data, amlitelimab would not represent a meaningful improvement to the standard of care for patients with AD.
Further results are planned to be presented at a forthcoming medical meeting.
Sanofi said it will work with investigators, study sites and regulatory authorities to wind down ongoing atopic dermatitis studies while ensuring appropriate transition of care for enrolled patients. The company noted that the decision does not change its full-year 2026 financial guidance.
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