French healthcare company Sanofi S.A. (Euronext Paris:SAN) (Nasdaq:SNY) on Friday reported positive data from two global phase 3 studies, SHORE and COAST 2, supporting the potential of amlitelimab in patients aged 12 years and older with moderate-to-severe atopic dermatitis.

Amlitelimab is a fully human non-T cell depleting monoclonal antibody that selectively targets OX40-ligand, a key immune regulator.

In the SHORE study, amlitelimab combined with topical therapies met all primary and key secondary endpoints at Week 24, with efficacy increasing over time and some patients improving as early as Week 2. In COAST 2, amlitelimab met the primary endpoint of vIGA-AD 0/1 for the US and US reference countries but did not achieve statistical significance for co-primary endpoints in the European Union and EU reference countries.

Based on the totality of phase 3 data, Sanofi plans to proceed with global regulatory submissions for amlitelimab.

A preliminary analysis from the open-label ATLANTIS phase 2 study showed continued and progressive improvements through Week 52 with no evidence of a treatment plateau.

Across studies, amlitelimab was well-tolerated with a safety profile consistent with previously reported data. The results reinforce OX40-ligand as a potential new therapeutic mechanism in atopic dermatitis.