Sanofi’s amlitelimab highlights its potential in atopic dermatitis

Sanofi announces that following the positive COAST 1 results in September 2025, two additional global phase 3 studies – SHORE – of amlitelimab, a fully human non-T cell depleting monoclonal antibody that selectively targets OX40-ligand, today delivered a robust body of evidence that supports amlitelimab’s potential in the treatment of patients 12 years and older with moderate-to-severe atopic dermatitis. I

“Importantly, these results validate amlitelimab’s novel mechanism of action to block OX40-ligand without T-cell depletion and its promise to normalize the immune system over time,” said Houman Ashrafian, Executive Vice President, Head of Research & Development at Sanofi. “The totality of data seen to date reinforce our confidence in amlitelimab’s potential to deliver both Q12W dosing from the start and progressive efficacy through Week 52. We look forward to sharing additional results, including longer-term data, as we move toward global regulatory submissions.”

Note that the key endpoints were measured at Week 24 in patients aged 12 years and older with moderate-to-severe AD who received amlitelimab either every four weeks or every 12 weeks. For US and US reference countries, the single primary endpoint was the proportion of patients with a validated investigator global assessment scale for AD of 0 or 1 and a reduction from baseline score of ≥2 points, analyzed using non-responder imputation.

---

---

Related Topics and Keywords

AMLITELIMAB, atopic dermatitis, Sanofi