Sanofi has reported positive Phase III results for first-in-class OX40L inhibitor amlitelimab in atopic dermatitis, with both every four-week and every twelve-week dosing regimens meeting all primary and secondary endpoints. The non-T-cell-depleting antibody demonstrated 21.1% to 29.1% validated Investigator Global Assessment response versus 9.2% to 10.5% for placebo, and 35.9% to 50.3% EASI-75 improvement versus 19.1% to 27.6% for placebo across different analysis methods. Efficacy increased progressively without plateauing throughout the 24-week treatment period.

Safety profiles showed similar adverse event rates between treatment and placebo groups, with higher injection site reactions (2.2% vs 0.7%) but lower fever and chills incidence. Amlitelimab blocks OX40 ligand-receptor interaction while maintaining T-regulatory cell balance, offering a novel mechanism for immune-inflammatory diseases including asthma and hidradenitis suppurativa. The results position amlitelimab to challenge Dupixent's dominance in the atopic dermatitis market.

PharmCube's NextBiopharm® database shows a total of 20 OX40L inhibitor projects following on Sanofi's track, mostly in pre-clinical stage. Click here to request a free trial for NextBiopharm®.