▎WuXi AppTec Content Team Report

The official website of the Chinese Drug Clinical Trial Registration and Information Disclosure Platform has recently announced,SanofiSanofi(Sanofi) has just recentlyLaunch a new international multi-center (including China) Phase 3 clinical trial for amlitelimab injection, aimed at evaluating the product's efficacy againstModerate to Severe Atopic Dermatitis in Patients Aged 12 Years and AboveThe efficacy and safety of patients. According to the announcement, this isAmplitelimab Injection Initiated in China for Atopic DermatitisMaintain efficacy after discontinuationPhase 3 clinical study.

According to publicly available information from Sanofi,Amlitelimab is a potential "first-in-class" OX40 signaling pathway blocker,Has PotentialOnly requires dosing once every 12 weeks., which can significantly reduce the treatment burden on patients.Notably, in December 2023, SanofiR&D DayAbove indicates that there are 12 new molecular entities (NMEs) in its R&D pipeline with the potential to become blockbuster drugs, including amlitelimab.

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

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. In addition, the productWhile suppressing T cell-dependent inflammation, it does not lead to the depletion of immune cells, potentially avoiding the side effects of immunosuppression.

In addition, previous studies have already shown,Even after discontinuation of amlitelimab, it can still modulate inflammatory T cells by blocking OX40L, achieving durable disease control.

Phase 2The STREAM-AD study has previously explored continuing or stoppingAmlitelimab TreatmentClinical response of patients during an additional 28-week period. The results showed,InAt Week 52, Atopic Dermatitis-Related Biomarkers Remain Reduced in Patients Who Discontinued and Continued Amlitelimab。Observed in Week 24Serum Thymus Activation Regulated Chemokine (TARC), eosinophils, and IL-22 remained unchanged during the discontinuation period and in patients who continued treatment up to week 52.

This Phase 3 trial launched by Sanofi in China is a multi-national, multi-center, randomized, double-blind, placebo-controlled, parallel-group study.48-Week Extension Study。The main purpose of this study is to evaluate, in responders with moderate-to-severe atopic dermatitis,Compared with discontinuation, the maintenance of treatment response with amlitelimab monotherapy every 4 weeks and switching to amlitelimab every 12 weeks。This study plans to enroll 961 subjects internationally, including 98 subjects planned for enrollment in China.

Globally, researchers are evaluating the clinical application potential of amlitelimab in multiple Phase 2 and Phase 3 clinical studies, including participants with atopic dermatitis (AD) across different treatment backgrounds. According to the official website of the China Drug Clinical Trial and Information Disclosure Platform, several international multicenter (including China) Phase 3 clinical trials of amlitelimab for atopic dermatitis (AD) are currently underway, such asModerate to severe AD in patients aged 12 years and above with inadequate response to previous biologic therapy or oral JAK inhibitor treatment, using topical corticosteroids as background therapy.Subjects, etc.

In addition to targeting atopic dermatitis,Amlitelimab alsoHas the potential to treat a range of immune-mediated and inflammatory diseases, including systemic sclerosis, asthma, hidradenitis suppurativa, scleroderma, celiac disease, alopecia areata, and more. In China,Sanofi has launchedamlitelimabTargetingSystemic Sclerosis-Associated Interstitial Lung Disease and Alopecia AreataPhase 2 Clinical Study.

OX40 is a co-stimulatory receptor primarily present on activated T cells, which interacts withOX40-Ligand (OX40L，A Key Immune Regulator）The interaction provides crucial 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.. According to publicly available information,GloballyDozens of drugs targeting OX40 have entered the clinical research stage, including AMG 451 (rocatinlimab), which is under development by Amgen and has recently entered China.Approved for Clinical Use, is being developed to treat prurigo nodularis; IMG-007, a non-depleting anti-OX40 monoclonal antibody from Innovent Biologics, is under development for the treatment of atopic dermatitis, etc.

In addition to targeting inflammatory diseases,The use of OX40 and OX40L costimulatory signals for cancer treatment is also one of the most important research directions for this target.Public data shows that BeiGene's anti-OX40 antibody BGB-A445 and Innovent Biologics' investigational hexavalent OX40 agonist antibody ES102 are currently both under development for the treatment of cancer patients.

We look forward to more good news, which will bring new treatment options to more patients as soon as possible.

[1] China Drug Clinical Trial Registration and Information Disclosure Platform. From http://www.chinadrugtrials.org.cn/clinicaltrials.searchlistdetail.dhtml

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

[3]Press Release: New Phase 2b results for amlitelimab support potential for best-in-class maintenance of response in atopic dermatitis. Retrieved Mar 11, 2023, from https://www.sanofi.com/en/media-room/press-releases/2024/2024-03-11-06-00-00-2843456