Sanofi Initiates Global First Phase III Trial of Subcutaneous IL-33 Monoclonal Antibody Itepekimab for Chronic Rhinosinusitis with Nasal Polyps in China

Feb 18, 2025 15:10 CST Updated 15:10

Sanofi

Pharmaceutical R&D Developer

On February 18, the official website of the Drug Clinical Trial Registration and Information Disclosure Platform showed that Sanofi registered a clinical trial for Itolizumab.(Itepekimab, IL-33 monoclonal antibody)TreatmentPoorly Controlled Chronic Rhinosinusitis with Nasal PolypsPhase III Study（CTR20250539）。

ItolizumabYesThe world's first subcutaneously injectable IL-33 antibody drug to enter Phase III,Initiated treatment earlierTherapyChronic Obstructive Pulmonary Disease（COPD）Phase III Clinical Trial。This timeIt is the first time that the drug has initiated a Phase III clinical trial for the treatment of chronic rhinosinusitis.Also the first to enter in this indicationStage III IL-33 Antibody。

Screenshot source: Drug Clinical Trial Registration and Information Disclosure Platform

This is a randomized, double-blind, placebo-controlled, parallel-group, 52-week Phase III trial designed to evaluate the efficacy, safety, and tolerability of etokimab in participants with poorly controlled chronic rhinosinusitis with nasal polyps.The primary endpoint of the study is the change from baseline in endoscopic NPS and NCS at 24 weeks.. A total of 102 institutions participated in the trial, with plans to enroll 33 people in China and 210 people internationally.

Interleukin 33(IL-33）Considered to play a key role in type 1 and type 2 inflammation.Itregimab is a product co-developed by Sanofi and Regeneron.SkinSubcutaneous InjectionIL-33 Monoclonal Antibody, is a fully human monoclonal antibody generated using Regeneron's proprietary VelocImmune technology.

Itolizumab: Great Potential for Indications

InIn terms of indications for chronic sinusitis, in addition to the recent initiation ofPhase III clinical trials for chronic rhinosinusitis with nasal polyps,Sanofi and Regeneron Launch for the First Time in November 2024Chronic Rhinosinusitis without Nasal PolypsPhase II Clinical Study（NCT06691113）The first patient was enrolled in December 2024, and the relevant clinical trials are actively progressing.

In addition, Sanofi and Regeneron willChronic Obstructive Pulmonary Disease（COPD）Indications have also been pushed to Phase III clinical trials. As early as202In January 2023, Sanofi and Regeneron initiated two assessmentsItolizumab TreatmentPrevious smokerCOPD PatientPhase III Clinical Study(NCT04701983 and NCT04751487). In January 2024, Sanofi and Regeneron initiated another evaluation based on the subjects who had participated in the two aforementioned studies.ItolizumabA Study on the Long-term Safety and Tolerability in COPD Subjects（NCT06208306）。

Screenshot source: Insight database

In addition to COPD and chronic sinusitis,Sanofi and Regeneron TargetItolizumabAlso laid outIndications such as asthma, atopic dermatitis, and non-cystic fibrosis bronchiectasis. Unfortunately,Itolizumab inSpecialSetback in Atopic Dermatitis。

In 2024,Ituxizumab Monotherapy（NCT03738423）AndItolizumab/Dupilumab Combination Therapy（NCT03736967）TheTwo Global Phase II Studies inThe interim analysis of the proof-of-concept study was terminated because the analysis failed to demonstrateItolizumab inSpecialAtopic DermatitisThe efficacy.

Twelve IL-33 Targeted Drugs in Development Globally

IL-33, as an important molecular target in the field of allergic and autoimmune disease treatment, has attracted widespread attention from the pharmaceutical industry in recent years.HoweverNo related targeted therapies available globallyDrugApproved for Marketing。Insight database shows,Currently, there are 12 drugs in development globally, 10 of which have entered the clinical stage.。

Data Source: Insight Database

From the clinical progress,AstraZenecaTozorakimab andSanofi/RegeneronEptinezumab has progressed the fastest and has entered Phase III clinical trials. Notably,Eptinezumab isThe World's FirstIL-33 Targeted Drugs in Phase III Clinical Trials. In addition, four drugs have entered Phase II clinical trials, respectively fromPfizer, Mitsubishi Tanabe, Eli LillyAnd AnaptysBio。

In terms of ingredient categories, except forPfizerTreatmentAtopic DermatitisExcept for PF-07264660, the remaining 9 drugs are all monoclonal antibodies. Based on the IL-33 target, Pfizer has added the IL-4 and IL-13 targets, further expanding the therapeutic potential of the drug. IL-4 and IL-13 are important cytokines in the pathogenesis of atopic dermatitis.Atopic DermatitisPlays a key role in the occurrence and development.

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