Full Press Release Details
New, late-breaking data at EADV highlights emerging clinical profile of amlitelimab (formerly KY1005) in adults
with inadequately controlled moderate-to-severe atopic dermatitis
PARIS September 30, 2021 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:
Also, at 16 weeks, key secondary endpoint data included:
The amlitelimab data presented at EADV support our belief that OX40-Ligand
has the potential to provide a novel approach to treating a range of immune-mediated diseases, said Naimish Patel, M.D. Head of Global Development in Immunology and Inflammation at Sanofi. This Phase 2a trial is the foundation of
our clinical trial program with amlitelimab in atopic dermatitis. The forthcoming global Phase 2b trial will further evaluate the impact of amlitelimab when given subcutaneously in patients with moderate-to-severe atopic dermatitis. The results from these two trials will help form the basis for designing a phase 3 clinical trial program to further evaluate the safety and efficacy of
Amlitelimab is a fully human non-depleting monoclonal antibody that binds to
OX40-Ligand, a key immune regulator, and has the potential to be a first-in-class treatment for a range of immune-mediated diseases and inflammatory disorders, including
moderate-to-severe atopic dermatitis. By targeting OX40-Ligand, amlitelimab aims to restore immune homeostasis between
pro-inflammatory and anti-inflammatory T cells.
Amlitelimab is being studied in patients with moderate-to-severe atopic dermatitis with suboptimal response to topical therapies. The potential for long-lasting treatment responses in atopic dermatitis patients may help
reduce the burden of frequent dosing, and further investigation will be conducted in a future Phase 2b study. Amlitelimab is currently under clinical investigation, and its safety and efficacy have not been evaluated by any regulatory authority.
In April 2021, Sanofi finalized the acquisition of Kymab, a clinical-stage biopharmaceutical company developing fully human monoclonal antibodies
with a focus on immune-mediated diseases and immuno-oncology therapeutics, adding amlitelimab to the company s dynamic pipeline.
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