Paris, May 3, 2023. Seventeen abstracts will be presented at this year’s American Thoracic Society International Conference (ATS 2023) taking place from May 19-24. Presentations include: two late-breaking abstracts from the Phase 3 Dupixent® (dupilumab) BOREAS trial for investigational use in chronic obstructive pulmonary disease (COPD); two oral presentations featuring new preclinical data on itepekimab, an IL-33 inhibitor, in COPD; and a late-breaking presentation from a Phase 1b study of SAR443765, an investigational bispecific NANOBODY® molecule targeting both thymic stromal lymphopoietin (TSLP) and interleukin-13 (IL-13) pathways.
Naimish Patel, M.D.
Head of Global Development, Immunology and Inflammation, Sanofi
“We are looking forward to sharing these first-of-their kind results for an investigational biologic from the pivotal trial of Dupixent in COPD, which we believe, if approved, have the potential to transform the treatment paradigm of this devastating and debilitating disease. The addition of our proof-of-mechanism data in asthma for SAR443765 further reinforces our commitment to advancing our understanding of the respiratory disease pathways with the goal of improving the lives of patients with serious respiratory diseases.”
An investor event with members of the Sanofi leadership team discussing these key presentations and updates on the company’s Immunology strategy will also be held in conjunction with the congress. The investor event will take place on Monday, May 22 from 6 p.m. to 7:30 p.m. CEST / Noon to 1:30 p.m. EDT (webcast only).
Additional information will be available on Sanofi’s Investor Relations website: https://www.sanofi.com/en/investors.
Data to be Presented at the 2023 ATS Annual Meeting
Chronic Obstructive Pulmonary Disease (COPD)
New research in COPD will evaluate the potential of targeting different aspects of airway inflammation that are believed to drive disease.
Detailed efficacy and safety data from the BOREAS trial, the first of two Phase 3 trials for investigational use of Dupixent in COPD, show that it is the first biologic that significantly reduced exacerbations and improved lung function, disease symptoms and quality of life for trial participants. The safety results were generally consistent with the known safety profile of Dupixent in its approved indications. The findings will be featured in two late-breaking oral presentation sessions, including the Breaking News: 2023 Clinical Trial Results in Pulmonary Medicine session. Positive topline data from the study, which met the primary and all key secondary endpoints, were previously announced in March 2023.
In addition, data from three abstracts on itepekimab assessing the IL-33 pathway blockade and its role in airway inflammation and lung remodeling will be presented. Itepekimab is a fully human monoclonal antibody that binds to and inhibits IL-33, an initiator and amplifier of broad inflammation in COPD.
- Oral Late-Breaker Presentation (May 22, 9:00-11:00am ET): Efficacy and Safety of Dupilumab in Chronic Obstructive Pulmonary Disease with Type 2 Inflammation
- Oral Presentation (May 23, 9:00-11:00am ET): Itepekimab Binds to IL-33 with High Affinity, Prevents the Formation of IL-33/ST2/IL-1RAcP Signaling Complex and Blocks Mediators of Airway Inflammation
- Oral Presentation (May 23, 9:00-11:00am ET): Interleukin-33 Drives Type 1 and Type 2 Inflammation and Instructs Airway Remodeling
- Poster Presentation (May 22, 9:00am-4:15pm ET): Blocking Either the IL-33 or IL-4Ra Pathway Attenuates Inflammatory Mediators of Airway Disease
Dupilumab and itepekimab are being jointly developed by Sanofi and Regeneron under a global collaboration agreement. The safety and efficacy of Dupixent and itepekimab in COPD have not been evaluated by any regulatory authority.
Moderate-to-Severe Asthma
Data from Sanofi’s Phase 1b study of SAR443765 in adults with asthma will be presented during the Breaking News: 2023 Clinical Trial Results in Pulmonary Medicine session. These results demonstrate proof-of-mechanism in asthma and are the first report of a novel biologic targeting both the TSLP and IL-13 pathways.
Additional presentations include new long-term safety findings from the LIBERTY ASTHMA TRAVERSE continuation study evaluating Dupixent up to five years in adolescents and adults with asthma, as well as results from a Phase 3 study assessing Dupixent efficacy and safety in adult and adolescent patients aged 12 and older with persistent asthma in the Asia-Pacific region.
- Oral Late-Breaker Presentation (May 22, 9:00-11:00am ET): Targeting of TSLP and IL-13 by the novel NANOBODY® molecule SAR443765 reduces FeNO in asthma following single dose exposure
- Poster Presentation (May 23, 2:15-4:15pm ET): Dupilumab Improved Long-Term Lung Function in Children Aged 6 to 11 Years with Moderate-to-Severe Asthma: LIBERTY ASTHMA EXCURSION
- Poster Presentation (May 23, 9:00am-4:15pm ET): Dupilumab Reduced Severe Exacerbation Rates and Improved Pre-Bronchodilator FEV1 in Patients with Moderate-to-Severe Asthma Regardless of Exacerbation History of ≥1, ≥2, or ≥3 Prior Exacerbations: LIBERTY ASTHMA TRAVERSE
- Poster Presentation (May 23, 2:15-4:15pm ET): Dupilumab Improves Lung Function in Children with Moderate-to-Severe Type 2 Asthma at Week 12
- Poster Presentation (May 23, 9:00am-4:15pm ET): Long-Term Safety of Dupilumab in Patients with Moderate-to-Severe Asthma: The LIBERTY ASTHMA TRAVERSE Continuation Study
- Poster Presentation (May 23, 2:15-4:15pm ET): Dupilumab Induces Clinical Remission in Patients with Uncontrolled, Moderate-to-Severe, Type 2 Inflammatory Asthma
- Poster Presentation (May 23, 9:00am-4:15pm ET): Efficacy of Dupilumab in Patients with and without a Minimally Important Reduction in Fractional Exhaled Nitric Oxide After 2 Weeks of Treatment
- Poster Presentation (May 22, 9:00am-4:15pm ET): Dupilumab Real-World Effectiveness (RWE) in Reducing Healthcare Resource Utilization Among Moderate-to-Severe Asthma Patients
- Poster Presentation (May 23, 2:15-4:15pm ET): Real-World Effectiveness of Dupilumab on Oral Corticosteroid Use and Asthma Exacerbations in Patients with Moderate-to-Severe Asthma
- Poster Presentation (May 23, 9:00am-4:14pm ET): Efficacy and Safety of Dupilumab in Patients with Persistent Asthma from the Asia-Pacific Region: A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Phase 3 Study
- Poster Presentation (May 23, 9:00am-4:15pm ET): Efficacy and Safety of Dupilumab in Patients from China with Persistent Asthma: A Subgroup Analysis of a Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Phase 3 Study
- Poster Presentation (May 23, 2:15-4:15pm ET): Comparative Effectiveness of Dupilumab Versus Omalizumab in Asthma Among Biologic-Naïve Patients: Findings from the Real-World US ADVANTAGE Study
- Poster Presentation (May 23, 9:00am-4:15pm ET): Real-World Effectiveness of Dupilumab in Biologic Naïve Patients with Asthma: Analysis from the US ADVANTAGE Study
The safety and efficacy of SAR443765 in asthma has not been evaluated by any regulatory authority.
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), prurigo nodularis and eosinophilic esophagitis (EoE).
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 600,000 patients are being treated with Dupixent globally.
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 6 investigational agents in Phase 1 clinical development, 5 in Phase 2 clinical development, and 1 in Phase 3 clinical development. These programs include investigational agents across a wide range of inflammatory conditions.
U.S. 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 12 years of age and older, who weigh at least 88 pounds (40 kg), with eosinophilic esophagitis (EoE). It is not known if DUPIXENT is safe and effective in children with eosinophilic esophagitis under 12 years of age and who weigh at least 88 pounds (40 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.
IMPORTANT SAFETY INFORMATION
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, 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.
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
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