▎WuXi AppTec Content Team Report

The official website of the Chinese Drug Clinical Trial Registry and Information Disclosure Platform has recently announced,Sanofi(Sanofi) has registered an international multicenter (including China) Phase 2 open-label, long-term study toAdult Subjects with Moderate to Severe Atopic DermatitisEvaluation of AmlitelimabSubcutaneous AdministrationSafety and efficacy.According to publicly available information from Sanofi,Amlitelimab is a potential "first-in-class" OX40 signaling pathway blocker.Has PotentialOnly requires treatment once every 12 weeks., which can significantly reduce the treatment burden on patients.

Screenshot source:China Drug Clinical Trial Registration and Information Disclosure Official Website

OX40 is a co-stimulatory receptor primarily present on activated T cells, which interacts withOX40-Ligand (OX40L，A Key Immune Regulator）The interaction provides important signals for T-cell activation, proliferation, and survival, thus this signaling pathwayPlays an important role in the pathogenesis of a series of inflammatory and immune diseases.。The immunomodulatory effect of OX40L enhances immune activity by regulating the proliferation and survival of effector T cells, while also suppressing the activity and proliferation of regulatory T cells.

Amlitelimab is a fully humanized, non-depleting monoclonal antibody administered by subcutaneous injection.It can interact withOX40LCombination，Aiming to restore immune homeostasis between pro-inflammatory and regulatory T cells, therebyIt has the potential to treat many immune-mediated and inflammatory diseases, including moderate to severe atopic dermatitis, asthma, etc. Additionally,The ProductWhile suppressing T cell-dependent inflammation, it does not lead to the depletion of immune cells, potentially avoiding the side effects of immunosuppression.

▲Introduction to Amlitelimab (Image Source: Reference [2])）

Sanofi's current registration in China is for an open-label, multinational, multicenter Phase 2 study aimed at evaluating the long-term safety, tolerability, and efficacy of amlitelimab in adult subjects with moderate to severe atopic dermatitis.Atopic dermatitis is a chronic, recurrent, inflammatory skin disease., up to one-third of adult patients have moderate to severe conditions, oftenThe symptoms are redness and swelling of the skin, accompanied by persistent itching, which may seriously affect the patient's quality of life.In the study,amlitelimabAdministered once every four weeks via subcutaneous injection, with a treatment duration of 160 weeks.The principal investigator of this study is Huashan Hospital, Fudan University.Dr. Xu Jinhua。

Previously,Amlitelimab TargetsAdult patients with moderate to severe atopic dermatitisOne itemPhase 2b Trial (STREAM-AD)Has already reached the primary endpoint. Patients treated with amlitelimabThe average score of the Eczema Area and Severity Index (EASI) at Week 16 improved by up to 61.5% from baseline and continued to improve over 24 weeks.。The product inThe trial also demonstrated good tolerability. In addition, the productPossibleHas the potential to require treatment only once every 12 weeks, reducing the treatment burden on patients.According to a previous press release from Sanofi,TheTrial data support amlitelimab as a potential "best-in-class" monoclonal antibody targeting the OX40-ligand.

▲Amlitelimab Clinical Trial Results(Image source: Reference [2])）

[1] China Drug Clinical Trial Registration and Information Disclosure Platform. Retrieved Feb 20, 2024, from http://www.chinadrugtrials.org.cn/clinicaltrials.searchlistdetail.dhtml

[2] Sanofi R&D day. Retrieved December 7, 2023, from https://www.sanofi.com/assets/dotcom/content-app/events/investor-presentation/2023/r-and-d-day-2023/Presentation.pdf