Divergent clinical trial outcomes On January 23, 2026, Sanofi released data from its Phase III programs (COAST 2 and SHORE) for amlitelimab, an anti-OX40 ligand monoclonal antibody targeting atopic dermatitis (eczema). The results presented a complex clinical picture:
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U.S. Market: The COAST 2 monotherapy trial met its primary endpoint, with significantly more patients achieving clear or almost clear skin (vIGA-AD 0/1) compared to the placebo group at Week 24.
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European Market: The study failed to reach statistical significance for its co-primary endpoints in the EU, largely due to an unexpectedly high placebo response rate, although numerical improvements were observed in treated patients.
Success in combination therapy In contrast to the monotherapy findings, the SHORE study—which evaluated amlitelimab in conjunction with topical corticosteroids—successfully met all primary and secondary endpoints in both U.S. and European analyses. Preliminary data suggest that the drug’s efficacy progressively increases over time, with sustained improvements documented through 52 weeks of treatment.
Global regulatory roadmap Despite the mixed performance in certain trial segments, Sanofi remains committed to pursuing global regulatory approvals in the second half of 2026, citing the “totality of data” as a strong foundation for clinical use. The company aims to position amlitelimab as a differentiated successor in the immunology space, offering a unique mechanism that rebalances the immune system and a convenient dosing schedule (every 12 weeks), providing a potential long-term solution for patients with moderate-to-severe eczema.