Media Update: ERS: new data across Sanofi’s immunology pipeline reinforce leadership in respiratory diseases
ERS: new data across Sanofi’s immunology pipeline reinforce leadership in respiratory diseases
- 31 abstracts to be presented across chronic inflammatory respiratory diseases, including four oral presentations and two late-breaking abstracts
- Late-breaking abstracts will include the TIDE-Asthma phase 2 study of amlitelimab and a new analysis evaluating the impact of Dupixent (dupilumab) on severe exacerbations in COPD
Paris, September 4, 2025. New data from 31 abstracts highlighting the potential of Sanofi’s approved and pipeline medicines to address critical gaps in care across chronic inflammatory respiratory diseases will be presented at the European Respiratory Society (ERS) International Congress. Data from Sanofi’s extensive immunology pipeline, including late-breaking data from the TIDE-Asthma phase 2 study (clinical study identifier: NCT05421598) evaluating amlitelimab, a fully human non-T cell depleting monoclonal antibody that blocks OX40-ligand (OX40L), in adult patients with moderate-to-severe asthma, will be featured.
Presentations related to Dupixent, which is developed in partnership with Regeneron, further solidify its role in improving outcomes across chronic respiratory conditions, including a late-breaking analysis from the BOREAS and NOTUS phase 3 studies (clinical study identifiers: NCT03930732 and NCT04456673) in chronic obstructive pulmonary disease (COPD). In addition, results from the EVEREST phase 4 head-to-head study (clinical study identifier: NCT04998604) in patients with chronic rhinosinusitis with nasal polyps (CRSwNP) and coexisting asthma will be shared in an oral presentation and simultaneously published in The Lancet Respiratory on Sunday, September 28 at 15:45 CEST.
“Chronic respiratory diseases can manifest through severe and aggressive symptoms and pose a significant burden on patients, which is why we are steadfast in our approach to research and treatment development,” said Alyssa Johnsen, MD, PhD, Global Therapeutic Area Head, Immunology and Oncology Development at Sanofi. “Our presentations at ERS underscore our commitment to addressing unmet patient needs and our goal of helping patients breathe better. New data from our immunology pipeline reinforce our progress across novel mechanisms and modalities, including amlitelimab, for the treatment of asthma. We also look forward to sharing results from our robust clinical program for Dupixent, which offer new insights into the future of treating asthma and chronic obstructive pulmonary disease.”
The ERS International Congress will be held in Amsterdam, Netherlands from September 27 to October 1, 2025. Notable presentations across pipeline and approved medicines include:
Immunology pipeline
New data for medicines in the immunology pipeline to be presented include:
- TIDE-Asthma phase 2 study: results evaluating amlitelimab in adult patients with moderate-to-severe asthma, including data on exacerbations, lung function and asthma control in a select biomarker defined population.
Amlitelimab is an investigational medicine, and its safety and efficacy have not been evaluated by any regulatory authority.
Dupixent
New data evaluating Dupixent’s impact on severe exacerbations, lung function and other key outcomes will be presented including:
COPD:
- BOREAS and NOTUS phase 3 studies: a late-breaking analysis assessing the impact of Dupixent on severe exacerbations.
Asthma:
- New data assessing the impact of Dupixent plus medium-dose inhaled corticosteroids compared to high-dose corticosteroids on clinical remission rates in adults and adolescents, as well as lung function and asthma control in children aged 6 to 11 years.
CRSwNP and Asthma:
- EVEREST phase 4 study: an oral presentation featuring results of the first-ever presented head-to-head trial in respiratory biologics evaluating Dupixent compared to omalizumab in patients with CRSwNP and coexisting asthma.
Complete list of ERS presentations:
| Presenting author | Abstract title | Presentation |
| Chronic obstructive pulmonary disease | ||
| Bafadhel | Dupilumab Reduces the Risk of Severe Exacerbations in Patients with Chronic Obstructive Pulmonary Disease: Results from BOREAS and NOTUS | # PA4778 Poster Presentation Tuesday, Sept 30 08:00 - 09:30 CEST |
| Bafadhel | Association Between Dupilumab and Repeated Exacerbations of Chronic Obstructive Pulmonary Disease: BOREAS and NOTUS | # PA4573 Poster Presentation Tuesday, Sept 30 08:00 - 09:30 CEST |
| Bhatt | Relationship Between Improvement in Lung Function and Patient-Reported Outcomes in Chronic Obstructive Pulmonary Disease with Dupilumab Treatment: Casual Mediation Analyses | # PA4577 Poster Presentation Tuesday, Sept 30 08:00 – 09:30 CEST |
| Franssen | Relationship Between Early Lung Function Improvement with Dupilumab and Long-Term Clinical Improvement in Chronic Obstructive Pulmonary Disease | # PA2471 Poster Presentation Monday, Sept 29 08:00 – 09:30 CEST |
| Hanania | The Number Needed to Treat with Dupilumab to Prevent Moderate or Severe Chronic Obstructive Pulmonary Disease Exacerbations: BOREAS and NOTUS | # PA4574 Poster Presentation Tuesday, Sept 30 08:00 – 09:30 CEST |
| Hurst | Dupilumab Efficacy in Patients with Chronic Obstructive Pulmonary Disease and Cardiovascular or Metabolic Disease: BOREAS and NOTUS | # PA4575 Poster Presentation Tuesday, Sept 30 08:00 – 09:30 CEST |
| Mannino | Effect of Add-On Dupilumab in Elderly Patients with Chronic Obstructive Pulmonary Disease: BOREAS and NOTUS | # PA4576 Poster Presentation Tuesday, Sept 30 08:00 – 09:30 CEST |
| Mayen | Cardiovascular Events and Pharmacological Treatment Patterns in Patients with Severe COPD Exacerbations: A US Payer Perspective | # PA370 Poster Presentation Sunday, Sept 28 08:00 - 09:30 CEST |
| Mayen | Healthcare Resource Utilisation and Healthcare Costs in COPD Patients with Moderate-to-Severe Exacerbations | # PA2560 Poster Presentation Monday, Sept 29 08:00 – 09:30 CEST |
| Mayen | Psychometric Validation of E-RS:COPD in Patients with Chronic Obstructive Pulmonary Disease | # PA2510 Poster Presentation Monday, Sept 29 08:00 – 09:30 CEST |
| Molina | Dupilumab as a Treatment in Patients with Gold-E Eosinophilic COPD: Experience in a Second-Level Hospital | # PA4584 Poster Presentation Tuesday, Sept 30 08:00 - 09:30 CEST |
| Ramakrishnan | Win Ratio Analysis of Dupilumab Efficacy in Patients with Chronic Obstructive Pulmonary Disease and Type 2 Inflammation: BOREAS and NOTUS | # PA4572 Poster Presentation Tuesday, Sept 30 08:00 – 09:30 CEST |
| Asthma | ||
| Akuthota | Amlitelimab Phase 2 Clinical Trial Results in Patients with Moderate-to-Severe Asthma | # OA1180 Oral Presentation Sunday, Sept 28 09:30 – 9:35 CEST |
| Al-Ahmad | Baseline Characteristics of Patients with Asthma Initiating Dupilumab in the Real-World REVEAL Registry | # PA478 Poster Presentation Sunday, Sept 28 08:00 – 09:30 CEST |
| Bacharier | Baseline Asthma Burden by Inhaled Corticosteroid Dose: Patients Initiating Dupilumab in RAPID | # PA5819 Poster Presentation Tuesday, Sept 30 12:30 – 14:00 CEST |
| Bourdin | Dupilumab Efficacy in Patients with Asthma and Allergic Bronchopulmonary Aspergillosis (ABPA) | # OA2337 Oral Presentation Sunday, Sept 28 16:05 – 16:10 CEST |
| Canonica | Impact of Dupilumab on Type 2 Inflammatory Biomarkers in Asthma by Baseline Inhaled Corticosteroid Dose and Clinical Remission Status After Treatment | # PA1500 Poster Presentation Sunday, Sept 28 12:30 – 14:00 CEST |
| Dell | Dupilumab Reduces Severe Exacerbation Rates and Total IgE Levels in Children with Type 2 Asthma, Irrespective of Transient Increase in Eosinophils | # PA5890 Poster Presentation Tuesday, Sept 30 12:30 – 14:00 CEST |
| Gomez | Burden and Healthcare Resource Utilization Across Asthma Severities | # OA2205 Oral Presentation Sunday, Sept 28 14:55 – 15:00 CEST |
| Martincova | Psychometric Validation of the Asthma Daytime/Nighttime Symptom Diary (ADSD/ANSD) in a Phase 2 Trial with Adults with Uncontrolled Asthma | # PA474 Poster Presentation Sunday, Sept 28 08:00 – 09:30 CEST |
| Maspero | Evaluation of ACQ-5 Components from the Rilzabrutinib Phase 2 Asthma Study | # PA2476 Poster Presentation Monday, Sept 29 08:00 – 09:30 CEST |
| Maspero | Efficacy Outcomes in Children with Asthma Receiving Dupilumab Plus Medium-Dose Inhaled Corticosteroids vs Children who Receive Placebo and Continue High-Dose Inhaled Corticosteroids | # PA5892 Poster Presentation Tuesday, Sept 30 12:30 – 14:00 CEST |
| Meng | Correlating FeNO Persistence and Lung Function Trajectories Among Patients with Uncontrolled Asthma | # PA1491 Poster Presentation Sunday, Sept 28 12:30 – 14:00 CEST |
| Mosnaim | Dupilumab Impact on Clinical Asthma Remission by Baseline Inhaled Corticosteroid Dose | # PA5710 Poster Presentation Tuesday, Sept 30 12:30 – 14:00 CEST |
| Shade | Impact of Rilzabrutinib on Inflammatory Responses in Human Mast Cells and Eosinophils | # PA380 Poster Presentation Sunday, Sept 28 08:00 – 09:30 CEST |
| Soliman | Efficacy and Safety of Add-On Dupilumab vs Inhaled Corticosteroid (ICS) Dose Escalation in Patients with Asthma Uncontrolled on Medium-Dose ICS/Long-Acting β2-Agonist (LABA) – AIM4: Next Step Study | # PA479 Poster Presentation Sunday, Sept 28 08:00 – 09:30 CEST |
| Wang | Identification of Suitable Sputum Processing Methods for Robust Downstream Biomarker Analysis in Bronchiectasis | # PA5269 Poster Presentation Tuesday, Sept 30 08:00 – 09:30 CEST |
| Watz | Real-World Outcomes After 2 Years of Dupilumab Therapy for Severe Asthma: The ProVENT Study | # PA477 Poster Presentation Sunday, Sept 28 08:00 – 09:30 CEST |
| Chronic rhinosinusitis with nasal polyps | ||
| Gomez | Characterizing the Burden of CRSwNP in the Biologic Era | # PA1409 Poster Presentation Sunday, Sept 28 12:30 –14:00 CEST |
| Heffler | Efficacy and Safety of Dupilumab vs Omalizumab in Chronic Rhinosinusitis with Nasal Polyps (CRSwNP) With Asthma (EVEREST Study) | # RCT1114 Oral Presentation Sunday, Sept 28 09:15 – 9:22 CEST |
| Radwan | Dupilumab Real-World Effectiveness through 18 Months in Patients with CRSwNP and Coexisting Asthma in the AROMA Registry | # PA5821 Poster Presentation Tuesday, Sept 30 12:30 – 14:00 CEST |
About Dupixent
Dupixent (dupilumab) is a fully human monoclonal antibody that inhibits the signaling of the interleukin 4 (IL4) and interleukin 13 (IL13) pathways and is not an immunosuppressant. The Dupixent development program has shown significant clinical benefit and a decrease in type-2 inflammation in phase 3 studies, establishing that IL4 and IL13 are two of the key and central drivers of type-2 inflammation that plays a major role in multiple related and often co-morbid diseases.
Dupixent has received regulatory approvals in more than 60 countries in one or more indications including certain patients with atopic dermatitis, asthma, chronic rhinosinusitis with nasal polyps, eosinophilic esophagitis, prurigo nodularis, chronic spontaneous urticaria, and chronic obstructive pulmonary disease in different age populations. More than 1,000,000 patients are currently being treated with Dupixent globally.
Dupilumab development program
Dupilumab is being jointly developed by Sanofi and Regeneron under a global collaboration agreement. To date, dupilumab has been studied across more than 60 clinical studies involving more than 10,000 patients with various chronic diseases driven in part by type-2 inflammation.
In addition to the currently approved indications, Sanofi and Regeneron are studying dupilumab in a broad range of diseases driven by type-2 inflammation or other allergic processes in phase 3 studies, including chronic pruritus of unknown origin, and lichen simplex chronicus. These potential uses of dupilumab are currently under clinical investigation, and the safety and efficacy in these conditions have not been fully evaluated by any regulatory authority.
About amlitelimab
Amlitelimab is a fully human, non-T cell depleting monoclonal antibody that blocks OX40L, a key immune regulator. With its novel mechanism of action, amlitelimab aims to normalize the overactive immune system and restore immune balance, without depleting T cells, with the goal of enabling a quarterly dosing interval for patients. It has the potential to be a first- or best-in-class treatment for a range of immune-mediated diseases and inflammatory disorders, including moderate-to-severe atopic dermatitis, moderate-to-severe asthma, systemic sclerosis, celiac disease, and alopecia.
About Sanofi
Sanofi is an R&D driven, AI-powered biopharma company committed to improving people’s lives and delivering compelling growth. We apply our deep understanding of the immune system to invent medicines and vaccines that treat and protect millions of people around the world, with an innovative pipeline that could benefit millions more. Our team is guided by one purpose: we chase the miracles of science to improve people’s lives; this inspires us to drive progress and deliver positive impact for our people and the communities we serve, by addressing the most urgent healthcare, environmental, and societal challenges of our time.
Sanofi is listed on EURONEXT: SAN and NASDAQ: SNY
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