Sanofi Showcases Expansive Respiratory Innovation and Scientific Leadership at ATS 2025 with Robust Clinical Data from Dupixent and Immunology Pipeline
Sanofi is poised to make a major impact at the 2025 American Thoracic Society (ATS) International Conference, taking place from May 18 to 21 in San Francisco, California. With 33 abstracts accepted for presentation, including one oral presentation and four late-breaking posters, Sanofi is reinforcing its leadership in chronic respiratory disease research by advancing its robust portfolio of immunological therapies and addressing key drivers of chronic inflammation, such as type 2 inflammation.
These presentations span both approved and investigational therapies and underscore Sanofi’s commitment to delivering transformative scientific breakthroughs across a spectrum of respiratory conditions. Central to Sanofi’s presence at the conference is the company’s focus on Dupixent® (dupilumab)—developed in collaboration with Regeneron—as well as emerging therapies from its immunology pipeline, including rilzabrutinib and novel approaches targeting key inflammatory pathways.
Strengthening a Legacy of Innovation in Respiratory Care
“At Sanofi, we are guided by a singular purpose: to transform the lives of people with chronic inflammatory diseases through innovative science,” said Dr. Alyssa Johnsen, Global Therapeutic Area Head for Immunology and Oncology Development at Sanofi. “The breadth of new data presented at ATS underscores our determination to tackle the most challenging aspects of chronic respiratory conditions. Whether through reducing exacerbations, improving lung function, or expanding access to disease-modifying therapies, we are committed to making a lasting difference in patients’ lives.”
Dr. Johnsen emphasized that Sanofi’s expanding clinical program is rooted in a deep understanding of immunological mechanisms and is positioned to deliver measurable improvements across chronic obstructive pulmonary disease (COPD), asthma, allergic bronchopulmonary aspergillosis (ABPA), and other respiratory illnesses.
Dupixent in COPD: Evidence from BOREAS and NOTUS Phase 3 Trials
Among the most highly anticipated data at ATS 2025 are new results from the BOREAS and NOTUS Phase 3 clinical studies, which evaluated Dupixent in patients with COPD characterized by type 2 inflammation. These pivotal trials collectively represent one of the most significant developments in COPD treatment in decades, as the condition has long lacked effective biologic treatment options.
The pooled analysis from both trials demonstrates that Dupixent not only reduces the rate of exacerbations but also improves lung function in COPD patients—regardless of whether they also had emphysema. This suggests a broad and consistent therapeutic benefit across the heterogeneous COPD population.
Further detailed analyses reveal that Dupixent led to sustained improvements across multiple spirometry measures, with efficacy maintained through 52 weeks of treatment compared to placebo. These data were particularly compelling as COPD progression is typically marked by a relentless decline in pulmonary function.
A late-breaking poster presentation will also highlight a win-ratio post-hoc analysis, assessing patients’ likelihood of avoiding a composite of severe disease outcomes—such as death, hospitalizations, worsening respiratory symptoms, and lung function deterioration—when treated with Dupixent compared to placebo. This integrated clinical outcome measure offers a real-world lens into the therapy’s impact on patients’ overall disease trajectory.
Importantly, safety outcomes from the BOREAS and NOTUS trials were generally consistent with Dupixent’s established safety profile across other approved indications. In pooled data, adverse events (AEs) more frequently observed with Dupixent (≥2%) included viral infections, headache, nasopharyngitis, back pain, diarrhea, arthralgia, urinary tract infections, local injection reactions, rhinitis, eosinophilia, toothache, and gastritis. Most patients enrolled had chronic bronchitis (≥95%), and over 30% had coexisting emphysema, offering a real-world reflection of the COPD population.
Expanding Dupixent’s Role in Asthma Management
Sanofi will also unveil new asthma data reinforcing Dupixent’s utility in improving lung function and reducing exacerbations across multiple subpopulations, including children and patients with mucus-dominant disease.
In the VESTIGE Phase 4 study, data from a late-breaking poster presentation show that Dupixent significantly reduced mucus burden—as measured by mucous plug scores and volume—as early as week 4. This effect was observed regardless of patients’ baseline levels of fractional exhaled nitric oxide (FeNO), an important biomarker for airway inflammation. Reducing mucus plugs is clinically relevant, as they contribute to airway obstruction and poor asthma control.
The VOYAGE Phase 3 trial focused on children aged 6 to 11 years with evidence of type 2 inflammation. Data demonstrate that Dupixent led to fewer exacerbations and improved overall asthma control, with more patients scoring ≤0.75 on the Interviewer-Administered 7-item Asthma Control Questionnaire—a recognized measure of disease stability. Notably, these benefits were seen regardless of disease duration, highlighting Dupixent’s ability to deliver meaningful outcomes early in the disease course.
In both asthma studies, the safety profiles were consistent with known data, although helminth infections were noted in the VOYAGE trial. Common AEs (≥5%) more frequent with Dupixent in VOYAGE included nasopharyngitis, upper respiratory tract infections, eosinophilia, and injection site reactions. In VESTIGE, COVID-19 and injection site reactions were the most frequently reported.
Advancing Understanding of Rare Respiratory Conditions: ABPA and Asthma
Sanofi will also present oral data from the LIBERTY ABPA AIRED Phase 2 study, which evaluated Dupixent in adults with allergic bronchopulmonary aspergillosis (ABPA) and asthma. ABPA is a progressive pulmonary condition driven by a hypersensitive immune response to Aspergillus fungi, which can colonize the airways of asthma patients and those with other chronic pulmonary conditions.
In this study, Dupixent was shown to improve lung function, reduce exacerbations, and enhance health-related quality of life, as measured by the St. George’s Respiratory Questionnaire. These findings are pivotal for ABPA, a disease that currently has few targeted treatment options and can lead to irreversible lung damage if not properly managed.
Pipeline Innovation: Rilzabrutinib and Next-Generation COPD Targets
Sanofi is also spotlighting pipeline assets at ATS 2025, including rilzabrutinib, an oral Bruton’s tyrosine kinase (BTK) inhibitor, and novel insights into dual cytokine pathway targeting.
A new Phase 2 trial of rilzabrutinib in adults with uncontrolled moderate-to-severe asthma shows that the therapy reduced loss of asthma control events over 12 weeks. These results were supported by a reduction in rescue medication use, suggesting better baseline disease control and symptom management.
In a separate presentation, Sanofi scientists will share transcriptomic data from patients with COPD to better understand how the combined targeting of interleukin-13 (IL-13) and thymic stromal lymphopoietin (TSLP) may offer a new therapeutic strategy. IL-13 and TSLP are key cytokines involved in type 2 inflammatory signaling, and dual inhibition could potentially provide more comprehensive control of inflammation in select COPD subgroups.
A Vision for the Future of Respiratory Medicine
The comprehensive scope of data being presented by Sanofi at ATS 2025 signals more than just clinical progress—it underscores a paradigm shift in how chronic inflammatory respiratory diseases may be managed in the future. Through ongoing innovation, collaborative research, and patient-centric clinical development, Sanofi aims to redefine the standard of care across multiple respiratory indications.
As Dr. Johnsen aptly noted, “By building on a foundation of strong immunological science, our goal is not only to address symptoms but to intervene in disease processes earlier and more effectively, offering new hope to patients who have long had limited options.”
With promising advances on display, including new clinical evidence for Dupixent in COPD and asthma, emerging therapies like rilzabrutinib, and bold investigational strategies targeting key inflammatory pathways, Sanofi’s commitment to respiratory health has never been more evident—or more urgently needed.
