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New data from 31 abstracts highlighting the potential of Sanofi’s approved and pipeline medicines to address critical gaps in care across chronic inflammatory respiratory diseases will be presented at the European Respiratory Society (ERS) International Congress. Data from Sanofi’s extensive immunology pipeline, including late-breaking data from the TIDE-Asthma phase 2 study (clinical study identifier: NCT05421598) evaluating amlitelimab, a fully human non-T cell depleting monoclonal antibody that blocks OX40-ligand (OX40L), in adult patients with moderate-to-severe asthma, will be featured.
Presentations related to Dupixent, which is developed in partnership with Regeneron, further solidify its role in improving outcomes across chronic respiratory conditions, including a late-breaking analysis from the BOREAS and NOTUS phase 3 studies (clinical study identifiers: NCT03930732 and NCT04456673) in chronic obstructive pulmonary disease (COPD). In addition, results from the EVEREST phase 4 head-to-head study (clinical study identifier: NCT04998604) in patients with chronic rhinosinusitis with nasal polyps (CRSwNP) and coexisting asthma will be shared in an oral presentation and simultaneously published in The Lancet Respiratory on Sunday, September 28 at 15:45 CEST.
“Chronic respiratory diseases can manifest through severe and aggressive symptoms and pose a significant burden on patients, which is why we are steadfast in our approach to research and treatment development,” said Alyssa Johnsen, MD, PhD, global therapeutic area head, immunology and oncology development at Sanofi. “Our presentations at ERS underscore our commitment to addressing unmet patient needs and our goal of helping patients breathe better. New data from our immunology pipeline reinforce our progress across novel mechanisms and modalities, including amlitelimab, for the treatment of asthma. We also look forward to sharing results from our robust clinical programme for Dupixent, which offer new insights into the future of treating asthma and chronic obstructive pulmonary disease.”
The ERS International Congress will be held in Amsterdam, Netherlands from September 27 to October 1, 2025. Notable presentations across pipeline and approved medicines include:
New data for medicines in the immunology pipeline to be presented include:
• TIDE-Asthma phase 2 study: results evaluating amlitelimab in adult patients with moderate-to-severe asthma, including data on exacerbations, lung function and asthma control in a select biomarker defined population.
• Amlitelimab is an investigational medicine, and its safety and efficacy have not been evaluated by any regulatory authority.
New data evaluating Dupixent’s impact on severe exacerbations, lung function and other key outcomes will be presented including:
• COPD: BOREAS and NOTUS phase 3 studies: a late-breaking analysis assessing the impact of Dupixent on severe exacerbations.
• Asthma: New data assessing the impact of Dupixent plus medium-dose inhaled corticosteroids compared to high-dose corticosteroids on clinical remission rates in adults and adolescents, as well as lung function and asthma control in children aged 6 to 11 years.
• CRSwNP and asthma: EVEREST phase 4 study: an oral presentation featuring results of the first-ever presented head-to-head trial in respiratory biologics evaluating Dupixent compared to omalizumab in patients with CRSwNP and coexisting asthma.
Dupixent (dupilumab) is a fully human monoclonal antibody that inhibits the signaling of the interleukin 4 (IL4) and interleukin 13 (IL13) 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 studies, establishing that IL4 and IL13 are two of the key and central drivers of 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 certain patients with atopic dermatitis, asthma, chronic rhinosinusitis with nasal polyps, eosinophilic esophagitis, prurigo nodularis, chronic spontaneous urticaria, and chronic obstructive pulmonary disease in different age populations. More than 1,000,000 patients are currently being treated with Dupixent globally.
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 studies 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 studies, including chronic pruritus of unknown origin, and lichen simplex chronicus. 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.
Amlitelimab is a fully human, non-T cell depleting monoclonal antibody that blocks OX40L, a key immune regulator. With its novel mechanism of action, amlitelimab aims to normalize the overactive immune system and restore immune balance, without depleting T cells, with the goal of enabling a quarterly dosing interval for patients. It has the potential to be a first- or best-in-class treatment for a range of immune-mediated diseases and inflammatory disorders, including moderate-to-severe atopic dermatitis, moderate-to-severe asthma, systemic sclerosis, celiac disease, and alopecia.
Sanofi is an R&D driven, AI-powered biopharma company committed to improving people’s lives and delivering compelling growth.
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