Sanofi's amlitelimab confirms its potential in atopic dermatitis

Following the positive COAST 1 results in September 2025, two additional global Phase III studies – SHORE and COAST 2 of amlitelimab, a fully human non-T cell depleting monoclonal antibody that selectively targets OX40-ligand (OX40L), 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 (AD).

In these two Phase III studies amlitelimab was well-tolerated and the safety profile was consistent with previously reported data, said the drug’s developer, French pharma major Sanofi (Euronext: SAN).

"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 R&D at Sanofi, adding: "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.”