lunsekimig (SAR443765) / Sanofi - LARVOL DELTA

PERSEPHONE: Efficacy, Safety, and Tolerability Study of Lunsekimig Compared With Placebo in Adult Participants With Inadequately Controlled Chronic Obstructive Pulmonary Disease (COPD) Characterized by an Eosinophilic Phenotype (clinicaltrials.gov) - P3 | N=942 | Recruiting | Sponsor: Sanofi | Not yet recruiting ➔ Recruiting

Enrollment open • Chronic Obstructive Pulmonary Disease • Immunology • Pulmonary Disease • Respiratory Diseases

THESEUS: Efficacy, Safety, and Tolerability Study of Lunsekimig Compared With Placebo in Adult Participants With Inadequately Controlled Chronic Obstructive Pulmonary Disease (COPD), Characterized by an Eosinophilic Phenotype (clinicaltrials.gov) - P3 | N=942 | Recruiting | Sponsor: Sanofi | Not yet recruiting ➔ Recruiting

Enrollment open • Chronic Obstructive Pulmonary Disease • Immunology • Pulmonary Disease • Respiratory Diseases

A Study to Investigate the Efficacy and Safety of Subcutaneous Lunsekimig (SAR443765) Compared With Placebo in Adult Participants With Moderate-to-severe Atopic Dermatitis (clinicaltrials.gov) - P2 | N=150 | Active, not recruiting | Sponsor: Sanofi | Recruiting ➔ Active, not recruiting | Trial completion date: Jul 2026 ➔ Apr 2026 | Trial primary completion date: Jun 2026 ➔ Dec 2025

Enrollment closed • Trial completion date • Trial primary completion date • Atopic Dermatitis • Dermatitis • Dermatology • Immunology

AIRPHRODITE: Long-term Safety and Efficacy Evaluation of Lunsekimig (SAR443765) in Adult Participants With Asthma. (clinicaltrials.gov) - P2 | N=900 | Recruiting | Sponsor: Sanofi | N=530 ➔ 900

Enrollment change • Asthma • Immunology • Pulmonary Disease • Respiratory Diseases

Late Breaking Abstract - Bispecific antibody targeting IL13 and TSLP for treatment of respiratory diseases (ERS 2025) - "These antibodies showed significantly better activity than Tezepelumab in TSLPR/STAT5 reporter and BaF3 proliferation assays...Furthermore, in an OVA+MC903-induced inflammation model using hTSLP/hTSLPR transgenic mice, HXN-1012 outperformed Lunsekimig in reducing skin inflammation and alleviating lung inflammation by lowering BALF cell counts, eosinophils, IgE, and CCL17 levels. HXN-1012 simultaneously inhibits TSLP and IL13, with each arm exhibiting activity comparable to the parent antibodies. HXN-1012 holds strong potential to improve clinical efficacy in the treatment of asthma, COPD and related respiratory diseases."

Late-breaking abstract • Asthma • Chronic Obstructive Pulmonary Disease • Dermatitis • Immunology • Inflammation • Pneumonia • Respiratory Diseases • CRLF2 • IL13 • IL7R • STAT5 • STAT5AWqe • TSLP

THESEUS: Efficacy, Safety, and Tolerability Study of Lunsekimig Compared With Placebo in Adult Participants With Inadequately Controlled Chronic Obstructive Pulmonary Disease (COPD), Characterized by an Eosinophilic Phenotype (clinicaltrials.gov) - P3 | N=942 | Not yet recruiting | Sponsor: Sanofi

New P3 trial • Chronic Obstructive Pulmonary Disease • Immunology • Pulmonary Disease • Respiratory Diseases

PERSEPHONE: Efficacy, Safety, and Tolerability Study of Lunsekimig Compared With Placebo in Adult Participants With Inadequately Controlled Chronic Obstructive Pulmonary Disease (COPD) Characterized by an Eosinophilic Phenotype (clinicaltrials.gov) - P3 | N=942 | Not yet recruiting | Sponsor: Sanofi

New P3 trial • Chronic Obstructive Pulmonary Disease • Immunology • Pulmonary Disease • Respiratory Diseases

A Proof-of-concept Study of Lunsekimig Compared With Placebo in Adults With Chronic Rhinosinusitis With Nasal Polyps (clinicaltrials.gov) - P2 | N=79 | Active, not recruiting | Sponsor: Sanofi | Recruiting ➔ Active, not recruiting

Enrollment closed • Chronic Rhinosinusitis With Nasal Polyps • Immunology • Nasal Polyps • Otorhinolaryngology • Respiratory Diseases • Sinusitis

Lunsekimig: Data readout from P2b AIRCULES trial (NCT06102005) for asthma in H1 2026 (Sanofi) - Q2 2025 Results

P2b data • Asthma • Immunology

AIRCULES: Dose Ranging Study of Lunsekimig Compared With Placebo-control in Adult Participants With Moderate-to-severe Asthma (clinicaltrials.gov) - P2 | N=685 | Active, not recruiting | Sponsor: Sanofi | Trial completion date: Jun 2026 ➔ Mar 2026 | Trial primary completion date: Jun 2026 ➔ Mar 2026

Trial completion date • Trial primary completion date • Asthma • Immunology • Pulmonary Disease • Respiratory Diseases

Preclinical Characterization of IBI3002, an Anti-IL-4Rα and Anti-TSLP Bispecific Antibody That Potently Dampens Inflammatory Response and Alleviates Asthma in Mice (ATS 2025) - "an innovative IL4RxTSLP bispecific antibody is characterized for its potent and synergistic inhibition of both IL4, IL13 and the upstream epithelial trigger TSLP. This molecule suppresses airway inflammation more potently than Dupixent, Tezepelumab and Lunsekimig even at lower concentration in-vitro or with lower exposure in-vivo. Therefore, IBI3002 can potentially bring broader and deeper clinical benefits to asthma patients of both high and med/low eosinophil counts."

Preclinical • Asthma • Immunology • Inflammation • Respiratory Diseases • CRLF2 • IL13 • IL4 • IL4R • TSLP

Long-term Safety and Efficacy Evaluation of Lunsekimig in Adult Participants With Chronic Rhinosinusitis With Nasal Polyps (CRSwNP) Who Completed a Previous Lunsekimig CRSwNP Study (clinicaltrials.gov) - P2 | N=64 | Recruiting | Sponsor: Sanofi | Not yet recruiting ➔ Recruiting

Enrollment open • Chronic Rhinosinusitis With Nasal Polyps • Immunology • Nasal Polyps • Otorhinolaryngology • Respiratory Diseases • Sinusitis

Lunsekimig's bispecific targeting of IL-13 and TSLP in asthma: dual targets for synergistic effects? (PubMed, Eur Respir J) - No abstract available

Journal • Asthma • Immunology • Pulmonary Disease • Respiratory Diseases • IL13 • TSLP

Press Release: Sanofi: strong Q1 performance and 2025 guidance confirmed (Sanofi Press Release) - "lunsekimig: A phase 2 study (clinical study identifier: NCT06790121) of three subcutaneous dose regimens of lunsekimig compared with matching placebos in adults with moderate-to-severe AD with a history of an inadequate response to topical treatments or for whom topical therapies are not advised commenced dosing the first patient."

Trial status • Atopic Dermatitis

A Study to Investigate the Efficacy and Safety of Subcutaneous Lunsekimig (SAR443765) Compared With Placebo in Adult Participants With Moderate-to-severe Atopic Dermatitis (clinicaltrials.gov) - P2 | N=144 | Recruiting | Sponsor: Sanofi | Not yet recruiting ➔ Recruiting

Enrollment open • Atopic Dermatitis • Dermatitis • Dermatology • Immunology

Long-term Safety and Efficacy Evaluation of Lunsekimig in Adult Participants With Chronic Rhinosinusitis With Nasal Polyps (CRSwNP) Who Completed a Previous Lunsekimig CRSwNP Study (clinicaltrials.gov) - P2 | N=64 | Not yet recruiting | Sponsor: Sanofi

New P2 trial • Chronic Rhinosinusitis With Nasal Polyps • Immunology • Nasal Polyps • Otorhinolaryngology • Respiratory Diseases • Sinusitis

Lunsekimig: potential for broader use in chronic obstructive pulmonary disease (COPD) (GlobeNewswire) - "The readout of the phase 2 study in patients with chronic rhinosinusitis with nasal polyps (clinical study identifier: NCT06454240) is anticipated in 2026....A phase 2/3 study in COPD is anticipated to begin in 2025."

New P2/3 trial • P2 data • Chronic Obstructive Pulmonary Disease • Chronic Rhinosinusitis With Nasal Polyps

AIRCULES: Dose Ranging Study of Lunsekimig Compared With Placebo-control in Adult Participants With Moderate-to-severe Asthma (clinicaltrials.gov) - P2 | N=685 | Active, not recruiting | Sponsor: Sanofi | Recruiting ➔ Active, not recruiting

Enrollment closed • Asthma • Immunology • Pulmonary Disease • Respiratory Diseases

A proof-of-mechanism trial in asthma with lunsekimig, a bispecific nanobody® molecule. (PubMed, Eur Respir J) - "A single dose of lunsekimig was well tolerated, significantly suppressed Type 2 inflammation, and improved lung function in mild-to-moderate asthma."

Journal • Asthma • Immunology • Inflammation • Pulmonary Disease • Respiratory Diseases • IL13 • TSLP

Lunsekimig: Data readout from P2b AIRCULES trial (NCT06102005) for asthma in 2026 (Sanofi) - Q4 & FY 2024 Results: Data readout from P2 trial (NCT06454240) for chronic rhinosinusitis with nasal polyps in 2026

P2 data • P2b data • Asthma • Chronic Rhinosinusitis With Nasal Polyps • Immunology

A Study to Investigate the Efficacy and Safety of Subcutaneous Lunsekimig (SAR443765) Compared With Placebo in Adult Participants With Moderate-to-severe Atopic Dermatitis (clinicaltrials.gov) - P2 | N=144 | Not yet recruiting | Sponsor: Sanofi

New P2 trial • Atopic Dermatitis • Dermatitis • Dermatology • Immunology

Study of Lunsekimig (SAR443765) Compared With Placebo in Adults With High-risk Asthma (clinicaltrials.gov) - P2 | N=1000 | Recruiting | Sponsor: Sanofi

New P2 trial • Asthma • Immunology • Pulmonary Disease • Respiratory Diseases

Sanofi Healthcare Gets CDSCO Panel Nod To Study Asthma Drug SAR443765 (Medical Dialogues) - "The drug major Sanofi Healthcare has got approval from the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation CDSCO to conduct the trial of the pulmonary drug SAR443765(lunsekimig) solution for injection 165 mg/1.1 mL (150 mg/mL). This came after the firm presented phase 2 clinical trial protocol no. LTS17231 Version No. 1 Protocol Date 07-JUN-2024. This is a phase 2, open-label extension study to evaluate the long-term safety and efficacy of lunsekimig in adult participants with moderate-to-severe asthma who have previously completed the parent study. After completion of the parent study, eligible participants will be offered the opportunity to participate in the long-term extension (LTE) study with Lunsekimig."

New P2 trial • Asthma • Immunology

AIRPHRODITE: Long-term Safety and Efficacy Evaluation of Lunsekimig (SAR443765) in Adult Participants With Moderatetosevere Asthma. (clinicaltrials.gov) - P2 | N=467 | Recruiting | Sponsor: Sanofi | Not yet recruiting ➔ Recruiting

Enrollment open • Asthma • Immunology • Pulmonary Disease • Respiratory Diseases

AIRPHRODITE: Long-term Safety and Efficacy Evaluation of Lunsekimig (SAR443765) in Adult Participants With Moderatetosevere Asthma. (clinicaltrials.gov) - P2 | N=467 | Not yet recruiting | Sponsor: Sanofi

New P2 trial • Asthma • Immunology • Pulmonary Disease • Respiratory Diseases