Sanofi Highlights Best-in-Class Potential of Amlitelimab in Phase IIb Trial for Moderate-to-Severe Atopic Dermatitis

On October 13, Sanofi announced that it had released detailed results of the Phase IIb STREAM-AD study of OX40L antibody Amlitelimab for the treatment of moderate-to-severe atopic dermatitis at the annual meeting of the European Academy of Dermatology and Venereology (EADV).

In this study, compared with placebo, patients who received four different doses of Amlitelimab for 16 weeks showed statistically significant improvements in the Eczema Area and Severity Index (EASI) scores. Among them, the group receiving a 500mg loading dose followed by a 250mg dose every 4 weeks showed the highest level of relief, with EASI decreasing by 61.5% from baseline at week 16 (P<0.0001) and by 64.4% at week 24 (P<0.0001), compared to 29.4% and 27.6% in the placebo group, respectively.

Moreover, the proportion of patients with ≥75% improvement in EASI from baseline at weeks 16 and 24; the proportion of patients with IGA scores of 0 (completely clear skin) or 1 (almost completely clear), and an improvement of at least 2 points from baseline; and the proportion of patients with ≥4-point improvement in weekly itch score (NRS) also demonstrated clinically significant improvements in key secondary endpoints.

At weeks 16 and 24, 22.1% and 45.5% of patients in the 250mg dose group achieved IGA 0/1, compared to 5.1% and 11.4% in the placebo group (P=0.0022 and P<0.0001), respectively. Additionally, 40.3% and 54.5% of patients reached EASI 75, compared to 11.4% and 17.7% in the placebo group (P<0.0001).

Different doses of Amlitelimab significantly reduced biomarkers associated with atopic dermatitis, including Th2-related IL-13 and TARC, Th17/Th22-related IL-17A and IL-22, as well as blood eosinophil counts. Significant reductions were observed as early as week 4 in the 250mg dose group.

In the study, Amlitelimab was well-tolerated, and no new safety issues emerged. The overall incidence of treatment-emergent adverse events (TEAEs) with Amlitelimab was 67.4%, compared to 60.3% in the placebo group. TEAEs more commonly observed with Amlitelimab than placebo included nasopharyngitis (Amlitelimab 11.0%, placebo 9.0%), COVID-19 (Amlitelimab 7.7%, placebo 6.4%), and headache (Amlitelimab 6.1%, placebo 2.6%). Worsening atopic dermatitis was more frequently observed in the placebo group (placebo 38.5%, Amlitelimab 17.1%) compared to Amlitelimab.

Sanofi stated that this study shows Amlitelimab has best-in-class potential for atopic dermatitis, with Phase III clinical trials expected to commence in the first half of 2024.

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