▎WuXi AppTec Content Team Report

The official website of the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) of China announced,Sanofi's申报的1类新药Amlitelimab Injection Receives Clinical Trial Implied Permission, Intended for Development to Treat Patients with Inadequately Controlled or Non-Recommended Use of Topical Prescription DrugsAdult Moderate to Severe Atopic DermatitisPatient. According to publicly available information from Sanofi,This is a potential “first-in-class” OX40 signaling pathway blocker.. In the Phase 2b clinical trial for the treatment of atopic dermatitis, the product significantly improved patients' disease symptoms at both 16 weeks and 24 weeks, andHas PotentialOnly requires treatment once every 12 weeks., significantly reducing the treatment burden on patients.

Screenshot source:CDE Official Website

Atopic Dermatitis (AD) is a chronic, recurrent, inflammatory skin disease., up to one-third of adult patients have moderate to severe symptoms, commonly presenting with skin redness and swelling accompanied by persistent itching, which may significantly impact the patient's quality of life.OX40 is a clinically validated therapeutic target for AD.The OX40 receptor-mediated signaling pathway is one of the important signaling pathways for T cell activation.

Amlitelimab is a fully humanized, non-depleting monoclonal antibody administered by subcutaneous injection, which binds to the OX40 ligand (OX40L，A key immune regulator) binding，Aimed at restoring immune homeostasis between pro-inflammatory and regulatory T cells.Compared with drugs targeting the OX40 receptor,It suppresses T cell-dependent inflammation without causing the depletion of immune cells, thereby potentially avoiding the side effects of immunosuppression.The ProductHas the potential to treat many immune-mediated and inflammatory diseases, including moderate to severe atopic dermatitis and asthma.

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

In aPhase 2b Trial (STREAM-AD)In China,amlitelimabCan significantly alleviate symptoms in adult patients with moderate to severe atopic dermatitis (AD),The trial met its 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,STREAM-ADTrial data support amlitelimab as a potential "first-in-class" and potential "best-in-class" monoclonal antibody targeting OX40-ligand.

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

[1] Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) of China. Retrieved Jan 9, 2024, from https://www.cde.org.cn/main/xxgk/listpage/4b5255eb0a84820cef4ca3e8b6bbe20c

[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