New data presented at AAAAI highlight Sanofi’s scientific leadership across inflammatory diseases
  • Late-breaking Dupixent® data leverages imaging technology to evaluate how Dupixent improves lung function in patients with uncontrolled moderate-to-severe asthma
  • Multiple oral presentations reinforce potential of Dupixent to provide relief to people with eosinophilic esophagitis as young as 1 year old through adulthood
  • First presentation of Phase 2 data for novel investigational oral BTK inhibitor rilzabrutinib in CSU; data forms the basis for Phase 3 program
  • Holistic presence underscores continued commitment to advancing therapies for patients across multiple inflammatory diseases

Paris, February 9, 2024. Twenty-three abstracts across approved and investigational medicines will be presented at this year’s American Academy of Allergy Asthma and Immunology (AAAAI) Annual Meeting from February 23 to 26. Abstracts include those evaluating Dupixent® (dupilumab) across six inflammatory diseases, including asthma, atopic dermatitis (AD), eosinophilic esophagitis (EoE), eosinophilic gastritis (EoG), chronic rhinosinusitis with nasal polyps (CRwNP), and chronic spontaneous urticaria (CSU); as well as rilzabrutinib in CSU.

Naimish Patel, M.D. 
Global Head of Development, Immunology and Inflammation at Sanofi  
“We are proud of our broad scientific presence at this year’s AAAAI, which underscores our commitment to working with our partner to continue to advance the science of Dupixent while also bringing forward novel and disruptive mechanisms of action that can address unmet needs. From novel imaging data that enables us to better understand the impact of Dupixent on lung function, to the latest EoE data in children as young as 1 year old, to the first presentation of our potentially best-in-class oral BTK inhibitor, we are committed to chasing the miracles of science for patients suffering from these chronic inflammatory conditions.

Notable presentations include:

Dermatology pipeline
A late breaking poster shows pipeline advancements in the treatment of patients with chronic spontaneous urticaria.

Rilzabrutinib in chronic spontaneous urticaria 

  • RILECSU Phase 2 Dose-Ranging Study: Data showed that rilzabrutinib significantly improved itch, hives and urticaria in adults with moderate-to-severe chronic spontaneous urticaria (CSU).

Rilzabrutinib was well-tolerated with most frequent adverse events being diarrhea and nausea.

Dupixent
Late breaking poster provides new insights into the effect of Dupixent on lung function and is the first study to use novel functional respiratory imaging to assess the effect of a biologic on lung function and airway volume. Additional oral presentations underscore the potential of Dupixent to transform the treatment paradigm for pediatric, adolescent, and adult patients with eosinophilic esophagitis (EoE).

Uncontrolled moderate-to-severe asthma

  • VESTIGE Phase 4 trial: Dupixent was associated with positive data on airway inflammation, mucus plugging, fractional exhaled nitric oxide (FeNO) and airway volume in patients with uncontrolled moderate-to-severe asthma.

Eosinophilic esophagitis

  • KIDS Phase 3 trial: Positive Dupixent data on histologic and endoscopic outcomes in children with EoE aged 1 through 11 years old at week 16 and through 52 weeks. Additional analysis will also be presented on gene expression in these children.i
  • LIBERTY-EoE-TREET study: Positive Dupixent data on histologic, symptomatic, and endoscopic aspects of EoE in adults and adolescents up to 52 weeks, regardless of prior elimination diet or food allergy.i

The safety results of these trials were generally consistent with the known safety profile of Dupixent.

Complete List of AAAAI 2024 Presentations:

Presenting author

Abstract title

Presentation details

Asthma

Bacharier

Improved Lung Function is Associated With Better Asthma Control in Children Aged 6 to 11 Years With Moderate-To-Severe Type 2 Asthma: A Post Hoc Analysis of VOYAGE

Poster #300
Poster session
Saturday, February 24
9.45-10.45 AM

Busse

Asthma Treatment With Add-On Dupilumab Plus Medium-Dose Inhaled Corticosteroid (ICS) Improved Lung Function and Asthma Control Compared With Placebo Plus High-Dose ICS

Poster #L23
Poster session (LB)
Saturday, February 24
9.45-10.45 AM

Castro

Evaluating the Effect of Dupilumab on Type 2 Airway Inflammation and Mucus Plugging in Patients with Uncontrolled Moderate-To-Severe Asthma: the VESTIGE Trial

Poster #L24
Poster session (LB)
Saturday, February 24
9.45-10.45 AM

Domingo

Association Of Baseline Lung Function and Likelihood of Oral Corticosteroid Reduction in Patients With OCS-Dependent Severe Asthma

Poster #308
Poster session
Saturday, February 24
9.45-10.45 AM

Peters

Coexisting Allergic Rhinitis in Patients With Moderate-To-Severe Asthma Initiating Dupilumab in Real-World Clinical Practice: The RAPID Registry Study

Poster #290
Poster session
Saturday, February 24
9.45-10.45 AM

Wechsler

Long-term Efficacy of Dupilumab in Patients with Moderate-to-severe Type 2 Asthma Stratified by Baseline Characteristics during the 96-week TRAVERSE Study

Poster #292
Poster session
Saturday, February 24
9.45-10.45 AM

Eosinophilic Esophagitis

Chehade

Dupilumab Improves Histologic and Endoscopic Outcomes in Children Aged 1 to <12 Years With Eosinophilic Esophagitis (EoE): 52-Week Results from the Phase 3 EoE KIDS Trial

Oral presentation #821
Oral abstract session Monday, February 26
12.50-1.00 PM

Chehade

Baseline Demographics and Disease Characteristics of Pediatric Patients With Eosinophilic Esophagitis (EoE) from the Randomised, Placebo-Controlled, Phase 3 EoE KIDS Study

Poster #620
Poster session
Sunday, February 25
9.45-10.45 AM

Rothenberg

Dupilumab Normalized the Expression of Genes Dysregulated in Eosinophilic Esophagitis (EoE) in Esophageal Biopsies from a Clinical Trial of Children Aged 1–11 Years 

Oral presentation #458
Oral abstract session Saturday, February 24
2.45-2.55 PM

Spergel

Dupilumab Is Efficacious Up To 52 Weeks in Patients with Eosinophilic Esophagitis Irrespective of Prior Food Elimination Diet or History of Food Allergy

Oral presentation #457
Oral abstract session Saturday, February 24
2.35-2.45 PM

Eosinophilic Gastritis

Dellon

A Phase 2/3 Study to Assess the Efficacy and Safety of Dupilumab Versus Placebo in Adults and Adolescents with Eosinophilic Gastritis With or Without Eosinophilic Duodenitis

Poster #621
Poster session
Sunday, February 25
9.45-10.45 AM

Atopic Dermatitis

Beck

 

 

Long-Term Efficacy of Dupilumab in Adults With Moderate-to-Severe Atopic Dermatitis: Results From A 5-Year Open-Label Extension Trial

Poster #015
Poster session
Friday, February 23
3.15-4.15 PM

Beck

Dupilumab Consistently Reduces CCL-17 (TARC) in Patients with Atopic Dermatitis Across All Age Groups

Poster #038
Poster session
Friday, February 23
3.15-4.15 PM

Bronova

Dupilumab Improves Skin Lipid Barrier in Pediatric Patients With Moderate-To-Severe Atopic Dermatitis

Poster #013
Poster session
Friday, February 23
3.15-4.15 PM

Kim

Dupilumab Reduction of IgE Levels and Probability of Atopic Dermatitis Flares – Analysis of A Randomized Placebo-Controlled 52-Week Study

Poster #044
Poster session
Friday, February 23
3.15-4.15 PM

Chronic Rhinosinusitis with Nasal Polyps

Desrosiers

 

Prevalence NSAID-ERD Among Patients with Chronic Rhinosinusitis with Nasal Polyps in the Global AROMA registry

Poster #657
Featured poster session Sunday, February 25
9.45-10.45 AM

Han

Baseline Use of Orals Corticosteroids Among Patients With Chronic Rhinosinusitis With Nasal Polyps Enrolled in the Global AROMA Registry

Poster #777
Featured poster session
Sunday, February 25
4.45-6.15 PM

Isaman

The Impact of Functional Endoscopic Sinonasal Surgery on Oral Corticosteroid Use and Costs Over 3 Years in Patients With Chronic Rhinosinusitis With Nasal Polyps in US Real-World Practice

Poster #777
Featured poster session
Sunday, February 25
9.45-10.45 AM

Peters

Baseline Disease Characteristics Among Patients with Chronic Rhinosinusitis with Nasal Polyps and Coexisting Asthma in the Global AROMA registry

Poster #652
Featured poster session
Sunday, February 25
9.45-10.45 AM

Chronic Spontaneous Urticaria

Maurer

Efficacy and Safety of Rilzabrutinib in Patients With Chronic Spontaneous Urticaria: 12-Week Results From the RILECSU Phase 2 Dose-Ranging Study

Poster# L38
Poster Session (LB)
Saturday, February 24
9:45 am - 10:45 AM

Maurer

Dupilumab Reduces Disease Activity in Patients with Chronic Spontaneous Urticaria: LIBERTY-CSU CUPID Study A

Poster #029
Poster session
Friday, February 23
3.15-4.15 PM

Maurer

Dupilumab Improves Dermatology-Specific Quality of Life in Patients with Chronic Spontaneous Urticaria Inadequately Controlled with H1 Antihistamines

Poster #007
Poster session
Friday, February 23
3.15-4.15 PM

Maurer

Dupilumab Improves Urticaria-Specific Quality of Life in Patients with Chronic Spontaneous Urticaria Uncontrolled by H1 Antihistamines

Poster #006
Poster session
Friday, February 23rd
3.15-4.15 PM

 

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 key and central drivers of the type 2 inflammation that plays a major role in multiple related and often co-morbid diseases. These diseases include approved indications for Dupixent, such as atopic dermatitis, asthma, chronic rhinosinusitis with nasal polyposis (CRSwNP), eosinophilic esophagitis (EoE) and prurigo nodularis.

Dupixent has received regulatory approvals in one or more countries around the world for use in certain patients with atopic dermatitis, asthma, CRSwNP, EoE or prurigo nodularis in different age populations. Dupixent is currently approved for one or more of these indications in more than 60 countries, including in Europe, the U.S. and Japan. More than 800,000 patients are 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 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 spontaneous urticaria, chronic pruritus of unknown origin, chronic obstructive pulmonary disease 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 Rilzabrutinib
Rilzabrutinib is an 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, expressed in B cells and mast cells, plays 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 Sanofi’s Immunology Pipeline
Through world-class R&D and a laser focus on patients, Sanofi discovers, develops and delivers best-in-class treatments that improve the lives of people living with chronic inflammatory diseases. Our scientific strategy for the future of immunology is built around the intentional choice of exploring disruptive mechanisms of actions beyond type 2 including NANOBODY molecules, synthetic cytokines and degraders. The immunology pipeline consists of 5 investigational agents in Phase 1 clinical development, 6 in Phase 2 clinical development, and 1 in Phase 3 clinical development. These programs include investigational agents across a wide range of inflammatory conditions.

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 some 100 countries, 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.

Media Relations
Sally Bain | + 1 617 834 6026 | sally.bain@sanofi.com

Investor Relations
Eva Schaefer-Jansen | + 33 7 86 80 56 39 | eva.schaefer-jansen@sanofi.com
Arnaud Delépine | + 33 06 73 69 36 93 | arnaud.delepine@sanofi.com
Corentine Driancourt | + 33 06 40 56 92 21 | corentine.driancourt@sanofi.com
Felix Lauscher | + 1 908 612 7239 | felix.lauscher@sanofi.com
Tarik Elgoutni | + 1 617 710 3587 | tarik.elgoutni@sanofi.com   
Nathalie Pham | + 33 07 85 93 30 17 | natalie.pham@sanofi.com

 

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i Thresholds for clinically meaningful changes in EREFS and HSS scores have not been established.