Sanofi has announced that its first-in-class OX40L-targeting monoclonal antibody (mAb), amlitelimab, met the primary endpoints in two Phase III trials (SHORE and COAST 2) for moderate-to-severe atopic dermatitis in adolescents and adults aged 12 and above. This follows a previous Phase III success in September 2025, positioning the drug as the most advanced OX40L inhibitor in development. Amlitelimab is designed to block the interaction between OX40L and its receptor to modulate immune response without depleting T-cells.

In the SHORE study, which evaluated amlitelimab in combination with topical therapies, both four-weekly and 12-weekly dosing regimens showed statistically significant improvements over placebo in validated Investigator Global Assessment and Eczema Area and Severity Index scores. The COAST 2 monotherapy study yielded similarly positive results. Based on the combined data from these trials, Sanofi plans to proceed with global regulatory submissions for the treatment of atopic dermatitis.

According to PharmCube's NextBiopharm® database, amlitelimab is under development in eight other immunology indications. Click here to request a free trial for NextBiopharm®.