Sanofi -PARIS - Positive results from a Phase 2a study evaluating the safety and efficacy of amlitelimab, a human monoclonal antibody targeting key immune system regulator OX40-Ligand, were presented as a late-breaker today at the European Academy of Dermatology and Venerology (EADV) 2021 Virtual Congress. In the study, amlitelimab showed significant improvements in signs and symptoms of moderate-to-severe atopic dermatitis with a well-tolerated safety profile in adults whose disease cannot be adequately controlled with topical medications or for whom topical medications are not a recommended treatment approach.

'While new options are increasingly available for the treatment of atopic dermatitis, individual patients have different responses to therapies and therefore require different solutions,' said Professor Stephan Weidinger, M.D., Ph.D., Vice Director, Professor, Department of Dermatology and Allergy, University Hospital Schleswig-Holstein. 'In the Phase 2a study presented at EADV, amlitelimab was shown to meaningfully improve the signs and symptoms of atopic dermatitis patients with moderate to severe disease with an unremarkable safety profile. These early results are exciting, and we look forward to seeking confirmatory data in future amlitelimab clinical trials.'

In this Phase 2a double-blind, placebo-controlled study, participants were randomized to either intravenous amlitelimab-low dose (LD) (n=29), intravenous amlitelimab-high dose (HD) (n=30) or placebo (n=29) and were treated every four weeks over a 12-week period. Eligible patients included adults with moderate-to-severe atopic dermatitis whose disease is inadequately controlled with topical therapies such as corticosteroids, or where such therapies were not advisable.

Co-primary endpoints included percent change in EASI from baseline, and incidence of treatment-emergent adverse events (TEAEs), at week 16.

At week 16, the data demonstrated that when dosed every four weeks:

Patients treated with amlitelimab-LD showed 80% improvement in average EASI from baseline, and patients treated with amlitelimab-HD showed 70% improvement in average EASI from baseline, compared to 49% for the placebo group (p=0.009 and p=0.072, respectively). The difference between amlitelimab-LD and placebo was nominally statistically significant.

The onset of response versus placebo was seen as early as Week 2 for both amlitelimab groups. No meaningful difference in responses was seen for the amlitelimab-LD and amlitelimab-HD groups.

The overall rate of TEAEs was 35% for amlitelimab-LD, 17% for amlitelimab-HD and 31% for placebo. One serious adverse event was reported in the amlitelimab-LD group (infected atheroma) deemed related by the investigator at week 16; the event was resolved, and the patient was able to complete the study. No hypersensitivity reactions were reported.

Also, at 16 weeks, key secondary endpoint data included:

44% of patients treated with amlitelimab-LD and 37% of patients treated with amlitelimab-HD achieved a score of 0 (clear) or 1 (almost clear) on the validated Investigator's Global Assessment (vIGA) scale compared with 8% with placebo (p

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