Global pharma powerhouse Sanofi has said that amlitelimab delivered strong results across multiple late-stage studies, clearing the way for global regulatory filings for the experimental atopic dermatitis treatment.

 

Data from two global phase 3 trials — SHORE and COAST 2 — showed that amlitelimab met key efficacy endpoints in patients aged 12 and older with moderate-to-severe atopic dermatitis, with improvements increasing throughout the treatment period and some patients responding as early as Week 2. The drug was well tolerated, and its safety profile was consistent with previously reported data.

 

In the SHORE phase 3 study, amlitelimab, used in combination with topical therapies, met all primary and key secondary endpoints at Week 24. Efficacy continued to build over time, reinforcing the treatment’s potential for sustained disease control.

 

The COAST 2 phase 3 study demonstrated statistically significant efficacy on the primary endpoint — achieving clear or almost clear skin based on the validated Investigator Global Assessment for atopic dermatitis (vIGA-AD 0/1) — in the United States and US reference countries. 

 

The results also confirmed the potential for every-12-week (Q12W) dosing from the start of treatment. However, amlitelimab did not reach statistical significance for the co-primary endpoints assessed for the European Union, EU reference countries, and Japan.

 

“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.”

 

Sanofi said it will proceed with global regulatory submissions based on the totality of evidence from the phase 3 program, which follows positive results from the earlier COAST 1 trial reported in September 2025.

 

Additional support for amlitelimab’s long-term potential came from a preliminary analysis of the ATLANTIS phase 2 study, which showed continued and progressive improvements through Week 52 with no evidence of a treatment plateau. The findings underscore the promise of targeting OX40-ligand as a new mechanism of action in atopic dermatitis.

 

Amlitelimab is a fully human, non–T-cell-depleting monoclonal antibody designed to selectively block OX40-ligand, a key driver of immune dysregulation in atopic dermatitis. Sanofi said further data, including longer-term outcomes, will be shared as the regulatory process advances.