Sanofi reported that its fully human, non‑T‑cell‑depleting antibody amlitelimab achieved the primary endpoint in the SHORE phase‑3 trial, with 55 % of patients reaching a vIGA‑AD 0/1 response at week 24 versus 20 % on placebo, and 48 % achieving an EASI‑75 response versus 18 % on placebo. The quarterly (Q4W) and every‑12‑weeks (Q12W) dosing schedules both met these criteria, underscoring the drug’s potential for less frequent administration.
In the COAST 2 trial, amlitelimab met the primary endpoint in the United States, with 53 % of patients achieving a vIGA‑AD 0/1 response versus 19 % on placebo. However, the European Union co‑primary endpoint was not met, with only 45 % of patients reaching the same response versus 20 % on placebo, highlighting regional differences in placebo response and trial conduct. ATLANTIS, a phase‑2 open‑label study, showed continued efficacy through week 52, with 50.3 % of patients achieving a vIGA‑AD 0/1 response and 76.5 % achieving an EASI‑75 response, while maintaining a safety profile consistent with earlier studies.
Safety data from ATLANTIS identified a single case of Kaposi’s sarcoma in a patient with known risk factors; no other serious adverse events were reported. The overall safety profile remains consistent with the drug’s mechanism of action, which blocks OX40‑ligand without depleting T cells.
These results position amlitelimab as a potential successor to Dupixent, which faces patent expiry in the coming years. The ability to administer the drug every 12 weeks could improve patient adherence and differentiate it from existing biologics. Sanofi plans to submit regulatory dossiers in the second half of 2026, aiming to secure approval in both the United States and the European Union.
Executive Vice President Houman Ashrafian emphasized that the data confirm amlitelimab’s novel mechanism of action and its promise to normalize immune function over time. He added that the Q12W dosing schedule could offer a more convenient treatment option for patients and clinicians alike.
Analysts note that while the SHORE data are encouraging, the mixed COAST 2 results temper enthusiasm, particularly for the EU market. The single Kaposi’s sarcoma case may prompt additional safety monitoring, but overall the data support continued development and regulatory submissions.
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