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.
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.
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.
The safety and efficacy of SAR443765 in asthma has not been evaluated by any regulatory authority.
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.
DUPIXENT is a prescription medicine used:
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:
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:
The most common side effects include:
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.
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