ERS: New data highlight Sanofi's scientific innovation and leadership in immune-mediated respiratory diseases

• Dupixent presentations of new pooled analyses from the two landmark COPD phase 3 studies, and novel imaging technology insights on airway inflammation in asthma
• Itepekimab phase 2 study oral presentation evaluating the impact on exacerbations in former smokers with COPD
• Additional phase 2 presentations in asthma for rilzabrutinib, a novel oral BTK inhibitor, and lunsekimig, an IL-13/TSLP Nanobody compound

Paris, August 26, 2024. Sanofi will present twenty-four abstracts across approved and pipeline medicines at the European Respiratory Society (ERS) International Congress from September 7th-11th in Vienna, Austria. Presentations will feature clinical and real-world data for Dupixent (dupilumab) and data for investigational therapy itepekimab (in collaboration with Regeneron) demonstrating the potential of targeting specific types of underlying inflammation across chronic obstructive pulmonary disease (COPD) and asthma to improve patient outcomes. Notable data presentations for Sanofi's extensive immunology pipeline include oral presentations for rilzabrutinib, a novel oral BTK inhibitor, evaluating safety and demonstrating efficacy on asthma symptom control, as well as poster presentations for lunsekimig, a novel IL13/TSLP Nanobody compound in asthma, evaluating its impact on type-2 inflammation.

Dietmar Berger, MD, PhD
Chief Medical Officer, Global Head of Development at Sanofi
"Our strong presence at this year's ERS conference highlights our diverse, novel research across inflammatory respiratory conditions, including COPD and asthma. For the first time, we will share pooled analyses from the landmark BOREAS and NOTUS trials that reinforce pivotal data, which led to the first approval of a biologic for COPD in the EU. In addition, we look forward to sharing data for two pipeline molecules, rilzabrutinib, a novel oral BTK inhibitor, and lunsekimig, an IL13/TSLP Nanobody compound, showing their potential in asthma. These data underscore our commitment to progressing science to better serve patients suffering from devastating respiratory diseases."

Notable presentations include:

Dupixent

Data from new analyses of the BOREAS and NOTUS phase 3 clinical studies in adults with uncontrolled COPD with evidence of type-2 inflammation, and new research from the phase 4 VESTIGE study, a novel imaging study evaluating the effects of Dupixent on airway remodeling measures in certain adults with asthma.

COPD

• BOREAS and NOTUS studies: poster presentation with a new pooled analysis of both pivotal studies, including data on exacerbations and lung function.
• BOREAS study: several poster presentations with detailed outcome assessments of Dupixent on daily symptom frequency and severity, the effect on exacerbations and lung function regardless of baseline body mass index, airflow obstruction, dyspnea (shortness of breath), and exercise capacity measures for adults with uncontrolled COPD with evidence of type-2 inflammation (i.e., raised blood eosinophils). Additional Dupixent data of its impact on quality of life, lung function and symptoms in patients who do not exacerbate.

Asthma

• VESTIGE study: two poster presentations with new data on the impact within four weeks of Dupixent treatment on airway inflammation, volume and flow, and mucus plugging, as well as outcomes for clinical remission at four and 24 weeks of treatment in adults with uncontrolled moderate-to-severe asthma. Additionally, an oral presentation on mucus plugging and volume.
• Real-world data: two poster presentations of real-world outcomes from the EU-ADVANTAGE study, including symptoms and oral corticosteroid use, for Dupixent compared to the IL5 antibodies benralizumab and mepolizumab, or omalizumab, an IgE antibody.

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

Respiratory pipeline
Data include new analyses for itepekimab, an IL33 antibody, in COPD, and rilzabrutinib, a novel oral BTK inhibitor, and lunsekimig, a IL13/TSLP Nanobody compound, in asthma.

COPD

• itepekimab: an oral presentation with new analyses from a COPD phase 2 study on the impact on exacerbations in former smokers regardless of exacerbation history.

Asthma

• rilzabrutinib: two oral presentations on the impact of treatment with rilzabrutinib in improving asthma control in adults with moderate-to-severe asthma, and on the role of BTK inhibition in eosinophilic inflammatory response.
• lunsekimig: two poster presentations on the broader benefits of lunsekimig, an IL-13/TSLP Nanobody compound on type-2 inflammation and the prevalence of elevated fractional exhaled nitric oxide in patients with mild-to-moderate asthma.

Itepekimab, rilzabrutinib and lunsekimig are investigational agents for which safety and efficacy have not been evaluated by any regulatory authority.

Complete list of ERS 2024 presentations:

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

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