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New data presented at ATS demonstrate Sanofi’s leadership in advancing potential new therapies for patients with immune-mediated respiratory diseases
  • Late-breaking data from the landmark NOTUS and BOREAS phase 3 studies support Dupixent’s role as a potential first-in-class biologic treatment for certain adult patients with uncontrolled COPD with type 2 inflammation
  • New findings from BOREAS study evaluate the role of biomarkers in predicting improvement in exacerbations and other responses to treatment
  • First presentation of phase 2b results for rilzabrutinib in asthma which forms the basis for a phase 3 program

Paris, April 26, 2024. Twenty-five abstracts across approved and investigational medicines will be presented at this year’s American Thoracic Society (ATS) International Conference taking place from May 17-22 in San Diego. Oral presentations will be given on data for Dupixent® (dupilumab), in partnership with Regeneron, evaluating its potential as a treatment for patients with chronic obstructive pulmonary disease (COPD) from two landmark phase 3 studies. Notable data presentations for Sanofi’s immunology pipeline include the first presentation of phase 2b asthma data for rilzabrutinib, a novel oral BTK inhibitor, and an oral presentation for lunsekimig, a novel IL-13/TSLP Nanobody® VHH, currently in phase 2b development for asthma.  

Naimish Patel, M.D. 
Global Head of Development, Immunology and Inflammation at Sanofi  
“Our robust presence at this year’s ATS conference showcases our novel research across inflammatory respiratory conditions, including COPD and asthma. The results from the pivotal NOTUS and BOREAS phase 3 studies for Dupixent further deepen our understanding of the role that type 2 inflammation plays in COPD and underscore the potential for Dupixent to be the first biologic approved for the treatment of COPD. We’re also excited to present new data for our two pipeline molecules, rilzabrutinib, an oral BTKi, and lunsekimig, our IL-13/TSLP Nanobody VHH, showing their first- and best-in-class potential in asthma. Our collective data at the meeting underscores our commitment and progress to improving the lives of patients suffering from devastating respiratory diseases.”

Dupixent
Notable presentations include new findings from the pivotal phase 3 Dupixent COPD program (NOTUS and BOREAS studies), which showed significant reduction in COPD exacerbations and improvements in lung function. Additionally, research from the VESTIGE phase 4 study, a novel imaging study evaluating the effects of Dupixent on lung function in adult patients with uncontrolled moderate-to-severe asthma, will be featured as a late-breaking oral presentation. Lastly, multiple poster presentations demonstrate the impact of Dupixent on asthma.

Clinical data in COPD

  • NOTUS study: detailed efficacy and safety results from the NOTUS phase 3 study evaluating Dupixent in patients with uncontrolled COPD and evidence of type 2 inflammation will be featured in a late-breaking oral presentation. Positive topline data from the study, which showed that Dupixent significantly reduced exacerbations, were previously announced in November 2023.
     
  • BOREAS study: findings across six abstracts from the BOREAS phase 3 study will be shared, including an analysis evaluating the treatment-by-biomarker interaction effects in patients with COPD, which will be presented in an oral abstract session as well as data on lung function.

Clinical data in uncontrolled moderate-to-severe asthma

  • VESTIGE clinical study: an oral abstract session will feature data on the effect of Dupixent on airway inflammation and mucus plugging in adults with uncontrolled moderate-to-severe asthma.
     
  • LIBERTY and VOYAGE studies: additional post-hoc analyses will be shared, including evaluating the impact of asthma duration on the efficacy of Dupixent in patients with uncontrolled moderate-to-severe asthma, clinical outcomes in patients with uncontrolled moderate-to-severe asthma who received Dupixent as an add-on to medium-dose inhaled corticosteroid, and the efficacy of Dupixent amongst children aged 6-11 with uncontrolled moderate-to-severe asthma.   

The safety results of these studies were generally consistent with the known safety profile of Dupixent in its approved respiratory conditions.

Respiratory pipeline
Presentations include data for investigational compounds rilzabrutinib, an oral BTK inhibitor, and lunsekimig, a new IL-13/TSLP Nanobody VHH, in asthma.

  • Phase 2b study of rilzabrutinib: a poster presentation will show the impact of treatment with rilzabrutinib on loss of asthma control (LOAC) events, asthma symptoms and quality of life in patients with moderate-to-severe asthma.
  • Lunsekimig: an oral presentation will show the impact of lunsekimig on multiple pathological immune cell populations and epithelial cell subpopulations. ​

Complete List of ATS 2024 presentations:
 

Presenting author 

Abstract title 

Presentation details 

COPD

Bafadhel

Dupilumab Does Not Impact Blood Eosinophil Levels in Patients with Moderate-to-Severe COPD and Type 2 Inflammation: From the Phase 3 Boreas Trial

7498

Poster Presentation

Sunday, May 19

9:15 – 11:15 AM PDT

Bhatt

A 3-year Descriptive Assessment of Exacerbations and Double/Triple Inhaler Use among chronic obstructive pulmonary disease (COPD) patients in the United States (US)

P584

Poster Presentation

Monday, May 20

11:30 AM – 1:15 PM PDT

Bhatt

Characterization of Chronic Obstructive Pulmonary Disease (COPD) in the United States

P585

Poster Presentation

Monday, May 20

11:30 AM – 1:15 PM PDT

Bhatt

Efficacy and Safety of Dupilumab in Patients With Moderate-to-Severe COPD and Type 2 Inflammation: Phase 3 NOTUS Trial 

15018

Oral Presentation

Monday, May 20

9:15 – 11:15 AM PDT

Bhatt

In the Phase 3 BOREAS Trial, Dupilumab Reduced FeNO Levels Over Time in Patients with Moderate-To-Severe COPD with Type 2 Inflammation

7547

Poster Presentation

Sunday, May 19

9:15 – 11:15 AM PDT

Buhl/Vogelmeier

Clinical and Economic Burden of COPD in Patients Poorly Controlled on LABA/LAMA or Inhaled Triple Therapy in Germany - A Retrospective Claims Data Analysis

P583

Poster Presentation

Monday, May 20

11:30 AM – 1:15 PM PDT

Christenson 

Dupilumab Increases the Proportion of Patients With Fractional Exhaled Nitric Oxide Levels <20 ppb Over Time in Patients With Moderate-to-Severe Chronic Obstructive Pulmonary Disease and Type 2 Inflammation: From Phase 3 BOREAS

7636

Poster Presentation

Monday, May 20

11:30 AM – 1:15 PM PDT

Christenson 

In the Phase 3 BOREAS Trial, Baseline Blood Eosinophils and Baseline Fractional Exhaled Nitric Oxide Levels Predict the Response to Dupilumab in Patients with Moderate-to-Severe Chronic Obstructive Pulmonary Disease and Type 2 Inflammation 

7654

Oral Presentation 

Tuesday, May 21 

2:15 – 4:15 PM PDT 

Hanania

Dupilumab Improves Post-Bronchodilator Lung Function in Patients with Moderate-to-Severe Chronic Obstructive Pulmonary Disease (COPD) with Type 2 Inflammation: Data from The Phase 3 BOREAS Trial

7422

Poster Presentation

Sunday, May 19

9:15 – 11:15 AM PDT

Heble

Treatment And Disease Burden Among Patients With Moderate Or Severe COPD: Real World Study

P604

Poster Presentation

Monday, May 20

11:30 AM – 1:15 PM PDT

Mularski

Association Between Serial Spirometric Improver Phenotype (Improved FEV1 Over Time) Versus Decliner Phenotype in Healthcare Utilization in Chronic Obstructive Pulmonary Disease

P133

Poster Presentation

Sunday, May 19

11:30 AM – 1:15 PM PDT

Papi

Dupilumab Improves Pre-Bronchodilator Lung Function Measures in Patients with Chronic Obstructive Pulmonary Disease (COPD) with Type 2 Inflammation: Data from The Phase 3 BOREAS Trial

7401

Poster Presentation

Sunday, May 19

9:15 – 11:15 AM PDT

Qureshi

Healthcare Resource Utilization and Disease Burden in Chronic Obstructive Pulmonary Disease (COPD) Patients With Type 2 Inflammation in the United States: Real-world Evidence

713

Poster Presentation

Sunday, May 19

2:15 – 4:15 PM PDT

Asthma

Washko

Effect of Dupilumab on Airway Oscillometry, Ventilation/Perfusion, and Mucus Plugging in Moderate-to-Severe Asthma: The Vestige Trial 

14998

Oral Presentation 

Monday, May 20

9:51 – 10:03 AM PDT

Bacharier

Improved Lung Function Is Associated With Better Asthma Control in Children With Moderate-To-Severe Type 2 Asthma: VOYAGE Study

8324

Poster Presentation 

Tuesday, May 21 

11:30 AM – 1:15 PM PDT

Bourdin

Dupilumab Asthma ADVANTAGE-EU: Real-World Evidence on the Association Between Dupilumab and Use of Corticosteroid and Asthma Exacerbations in Patients with Severe Asthma in Europe

10135

Poster Presentation 

Tuesday, May 21 

2:15 – 4:15 PM PDT 

Busse

Dupilumab Add-On to Medium-Dose Inhaled Corticosteroid (ICS) Increases Odds of Asthma Control and Reduces FeNO Compared With Placebo Add-On to High-Dose ICS

7437

Poster Presentation

Tuesday, May 21

11:30 AM – 1:15 PM PDT

Busse

Dupilumab Reduces Severe Exacerbations and Improves Lung Function in Patients with Type 2 Asthma Irrespective of Asthma Duration

8322

Poster Presentation

Tuesday, May 21

11:30 AM – 1:15 PM PDT

Do

Characterization of Patients with Severe Asthma Who Initiated Biologic Treatment Within ≤90 and >90 days After Biologic Eligibility

8484

Poster Presentation 

Wednesday, May 22 

8:15 – 10:15 AM PDT 

Jackson

Dupilumab Efficacy by Baseline Disease Severity Among Children with Uncontrolled Moderate-to-severe Asthma: Post-hoc Results from the Randomized, Placebo-controlled VOYAGE Trial

8302

Poster Presentation

Tuesday, May 21

2:15 – 4:15 PM PDT

Lipworth

Improved Lung Function Is Associated With Better Asthma Control in Adolescents and Adults Aged 12 Years and Older With Moderate-to-Severe Type 2 Asthma: A Post hoc Analysis of QUEST

7469

Poster Presentation

Tuesday, May 21

11:30 AM – 1:15 PM PDT

Pavord

Impact of Early Transient Increase in Eosinophil Count on the Long-Term Efficacy of Dupilumab in Patients With Moderate-to-Severe Asthma: LIBERTY ASTHMA TRAVERSE

7451

Poster Presentation

Tuesday, May 21

11:30 AM – 1:15 PM PDT

Porsbjerg

Effect of Dupilumab Treatment on Mucus Plugging and Mucus Volume in Type 2 Asthma: The Phase 4 VESTIGE Trial

15171

Poster Presentation

Sunday, May 19

11:30 AM – 1:15 PM PDT

Laidlaw

Efficacy and Safety of Rilzabrutinib - A Novel Oral Treatment in Asthma: Results From a Double Blind Placebo Controlled Phase 2b Study

15074

Poster Presentation

Wednesday, May 22

8:15 – 10:15 AM PDT 

Brahmachary

 

Single-Cell RNA Sequencing Analysis of Blood and Nasal Brushing From Asthma Patients Receiving a Single Dose of SAR443765, a novel, bispecific anti-TSLP/anti-IL-13 NANOBODY® Molecule Reveals Significant Impact on Multiple Pathological Immune Cell Populations and Downregulation of CCL26 Expression in Epithelial Cell Subpopulations

Oral Presentation

Monday, May 20

10:15 – 10:27 AM PDT

About Dupixent 
Dupixent is a fully human monoclonal antibody that inhibits the signaling of the interleukin-4 (IL-4) and interleukin-13 (IL-13) 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 trials, establishing that IL-4 and IL-13 are two of the key and central drivers of the 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 in certain patients with atopic dermatitis, asthma, chronic rhinosinusitis with nasal polyposis (CRSwNP), eosinophilic esophagitis (EoE), prurigo nodularis, and chronic spontaneous urticaria (CSU) in different age populations. More than 850,000 patients are being treated with Dupixent globally. Dupixent is currently under Priority Review by the U.S. Food and Drug Administration as an add-on maintenance treatment in certain adult patients with uncontrolled COPD.

About rilzabrutinib
Rilzabrutinib is an investigational oral, reversible, covalent BTK inhibitor that has the potential to be a first- or best-in-class treatment of a number of immune-mediated diseases, including CSU, prurigo nodularis, asthma, immune thrombocytopenia (ITP), IgG4-related disease and warm autoimmune hemolytic anemia (wAIHA). BTK is expressed in B cells, mast cells, eosinophils, basophils and macrophages which play a critical role in multiple immune-mediated disease processes. With the application of Sanofi’s TAILORED COVALENCY® technology, rilzabrutinib can selectively inhibit the BTK target while potentially reducing the risk of off-target side effects.    

About lunsekimig
Lunsekimig is an investigational novel nanobody VHH that combines targeting of IL-13, a downstream cytokine causing tissue organ damage in respiratory diseases and TSLP, an upstream initiator of inflammation. Pre-clinical research suggests that the combination of these targets can create more potent effect on type-2 inflammation, making lunsekimig a potentially best-in-class treatment for asthma and a range of other respiratory diseases.

Rilzabrutinib and Lunsekimig are under clinical investigation and their safety and efficacy have not been evaluated by any regulatory authority.

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 trials 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 trials, including chronic pruritus of unknown origin, chronic obstructive pulmonary disease (COPD) with evidence of type 2 inflammation, and bullous pemphigoid. 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. 

IMPORTANT SAFETY INFORMATION & INDICATIONS

Do not use if you are allergic to dupilumab or to any of the ingredients in DUPIXENT®.

Before using DUPIXENT, tell your healthcare provider about all your medical conditions, including if you:

  • have eye problems.
  • have a parasitic (helminth) infection.
  • are scheduled to receive any vaccinations.  You should not receive a “live vaccine” right before and during treatment with DUPIXENT.
  • are pregnant or plan to become pregnant. It is not known whether DUPIXENT will harm your unborn baby.
    • A pregnancy registry for women who take DUPIXENT during pregnancy collects information about the health of you and your baby. To enroll or get more information call 1-877-311-8972 or go to https://mothertobaby.org/ongoing-study/dupixent/.
  • are breastfeeding or plan to breastfeed. It is not known whether DUPIXENT passes into your breast milk.

Tell your healthcare provider about all the medicines you take, including prescription and over-the- counter medicines, vitamins, and herbal supplements.  

Especially tell your healthcare provider if you are taking oral, topical, or inhaled corticosteroid medicines; have asthma and use an asthma medicine; or have atopic dermatitis, chronic rhinosinusitis with nasal polyposis, eosinophilic esophagitis, or prurigo nodularis and also have asthma. Do not change or stop your corticosteroid medicine or other asthma medicine without talking to your healthcare provider. This may cause other symptoms that were controlled by the corticosteroid medicine or other asthma medicine to come back.

DUPIXENT can cause serious side effects, including:

  • Allergic reactions. DUPIXENT can cause allergic reactions that can sometimes be severe. Stop using DUPIXENT and tell your healthcare provider or get emergency help right away if you get any of the following signs or symptoms: breathing problems or wheezing, swelling of the face, lips, mouth, tongue or throat, fainting, dizziness, feeling lightheaded, fast pulse, fever, hives, joint pain, general ill feeling, itching, skin rash, swollen lymph nodes, nausea or vomiting, or cramps in your stomach-area.
  • Eye problems. Tell your healthcare provider if you have any new or worsening eye problems, including eye pain or changes in vision, such as blurred vision. Your healthcare provider may send you to an ophthalmologist for an exam if needed.
  • Inflammation of your blood vessels. Rarely, this can happen in people with asthma who receive DUPIXENT. This may happen in people who also take a steroid medicine by mouth that is being stopped or the dose is being lowered. It is not known whether this is caused by DUPIXENT. Tell your healthcare provider right away if you have: rash, chest pain, worsening shortness of breath, a feeling of pins and needles or numbness of your arms or legs, or persistent fever.
  • Joint aches and pain. Some people who use DUPIXENT have had trouble walking or moving due to their joint symptoms, and in some cases needed to be hospitalized. Tell your healthcare provider about any new or worsening joint symptoms. Your healthcare provider may stop DUPIXENT if you develop joint symptoms. 

The most common side effects include:

  • Eczema: injection site reactions, eye and eyelid inflammation, including redness, swelling, and itching, sometimes with blurred vision, dry eye, cold sores in your mouth or on your lips, and high count of a certain white blood cell (eosinophilia).
  • Asthma: injection site reactions, high count of a certain white blood cell (eosinophilia), pain in the throat (oropharyngeal pain), and parasitic (helminth) infections.
  • Chronic Rhinosinusitis with Nasal Polyposis: injection site reactions, eye and eyelid inflammation, including redness, swelling, and itching, sometimes with blurred vision, high count of a certain white blood cell (eosinophilia), gastritis, joint pain (arthralgia), trouble sleeping (insomnia), and toothache.
  • Eosinophilic Esophagitis: injection site reactions, upper respiratory tract infections, cold sores in your mouth or on your lips, and joint pain (arthralgia).
  • Prurigo Nodularis: eye and eyelid inflammation, including redness, swelling, and itching, sometimes with blurred vision, herpes virus infections, common cold symptoms (nasopharyngitis), dizziness, muscle pain, and diarrhea.

Tell your healthcare provider if you have any side effect that bothers you or that does not go away. These are not all the possible side effects of DUPIXENT. Call your doctor for medical advice about side effects. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

Use DUPIXENT exactly as prescribed by your healthcare provider. It’s an injection given under the skin (subcutaneous injection). Your healthcare provider will decide if you or your caregiver can inject DUPIXENT. Do not try to prepare and inject DUPIXENT until you or your caregiver have been trained by your healthcare provider. In children 12 years of age and older, it’s recommended DUPIXENT be administered by or under supervision of an adult. In children 6 months to less than 12 years of age, DUPIXENT should be given by a caregiver.

Please see accompanying full Prescribing Information including Patient Information.

INDICATIONS

DUPIXENT is a prescription medicine used:

  • to treat adults and children 6 months of age and older with moderate-to-severe eczema (atopic dermatitis or AD) that is not well controlled with prescription therapies used on the skin (topical), or who cannot use topical therapies. DUPIXENT can be used with or without topical corticosteroids. It is not known if DUPIXENT is safe and effective in children with atopic dermatitis under 6 months of age.
  • with other asthma medicines for the maintenance treatment of moderate-to-severe eosinophilic or oral steroid dependent asthma in adults and children 6 years of age and older whose asthma is not controlled with their current asthma medicines. DUPIXENT helps prevent severe asthma attacks (exacerbations) and can improve your breathing. DUPIXENT may also help reduce the amount of oral corticosteroids you need while preventing severe asthma attacks and improving your breathing. DUPIXENT is not used to treat sudden breathing problems. It is not known if DUPIXENT is safe and effective in children with asthma under 6 years of age.
  • with other medicines for the maintenance treatment of chronic rhinosinusitis with nasal polyposis (CRSwNP) in adults whose disease is not controlled. It is not known if DUPIXENT is safe and effective in children with chronic rhinosinusitis with nasal polyposis under 18 years of age.
  • to treat adults and children 1 year of age and older with eosinophilic esophagitis (EoE), who weigh at least 33 pounds (15 kg). It is not known if DUPIXENT is safe and effective in children with eosinophilic esophagitis under 1 year of age, or who weigh less than 33 pounds (15 kg).
  • to treat adults with prurigo nodularis (PN). It is not known if DUPIXENT is safe and effective in children with prurigo nodularis under 18 years of age.

About Sanofi
We are an innovative global healthcare company, driven by one purpose: we chase the miracles of science to improve people’s lives. Our team, across the world, is dedicated to transforming the practice of medicine by working to turn the impossible into the possible. We provide potentially life-changing treatment options and life-saving vaccine protection to millions of people globally, while putting sustainability and social responsibility at the center of our ambitions.  

Sanofi is listed on EURONEXT: SAN and NASDAQ: SNY 

Sanofi is listed on EURONEXT: SAN and NASDAQ: SNY

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