Sanofi Plans Regulatory Filings For Dupixent's Successor Despite Mixed Data From Pivotal Studies

On Friday, Sanofi SA (NASDAQ:SNY) shared data from two global phase 3 studies of amlitelimab, a fully human non-T cell depleting monoclonal antibody that selectively targets OX40-ligand (OX40L) to treat atopic dermatitis.

Amlitelimab is considered a potential successor to the blockbuster eczema drug Dupixent.

The company said the data 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).

Data

In these two phase 3 studies, amlitelimab was well-tolerated, and the safety profile was consistent with previously reported data.

In September 2025, Sanofi’s COAST 1 phase 3 study of amlitelimab failed to match investor expectations, though the trial met all primary and key secondary endpoints, demonstrating statistically significant and clinically meaningful skin clearance and disease severity compared to placebo.

For SHORE and COAST 2 phase ...