Media Update: New data presented at ATS demonstrate Sanofi’s leadership in advancing potential new therapies for patients with immune-mediated respiratory diseases

April 26, 2024 at 10:36 am EDT

Media Update

New data presented at ATS demonstrate Sanofi's leadership in advancing potential new therapies for patients with immune-mediated respiratory diseases

Late-breakingdata from the landmark NOTUS and BOREAS phase 3 studies support Dupixent's role as a potential first-in-class biologic treatment for certain adult patients with uncontrolled COPD with type 2 inflammation
New findings from BOREAS study evaluate the role of biomarkers in predicting improvement in exacerbations and other responses to treatment
First presentation of phase 2b results for rilzabrutinib in asthma which forms the basis for a phase 3 program

Paris, April 26, 2024. Twenty-five abstracts across approved and investigational medicines will be presented at this year's American Thoracic Society (ATS) International Conference taking place from May 17-22 in San Diego. Oral presentations will be given on data for Dupixent® (dupilumab), in partnership with Regeneron, evaluating its potential as a treatment for patients with chronic obstructive pulmonary disease (COPD) from two landmark phase 3 studies. Notable data presentations for Sanofi's immunology pipeline include the first presentation of phase 2b asthma data for rilzabrutinib, a novel oral BTK inhibitor, and an oral presentation for lunsekimig, a novel IL-13/TSLP Nanobody® VHH, currently in phase 2b development for asthma.

Naimish Patel, M.D.

Global Head of Development, Immunology and Inflammation at Sanofi "Our robust presence at this year's ATS conference showcases our novel research across inflammatory respiratory conditions, including COPD and asthma. The results from the pivotal NOTUS and BOREAS phase 3 studies for Dupixent further deepen our understanding of the role that type 2 inflammation plays in COPD and underscore the potential for Dupixent to be the first biologic approved for the treatment of COPD. We're also excited to present new data for our two pipeline molecules, rilzabrutinib, an oral BTKi, and lunsekimig, our IL-13/TSLPNanobody VHH, showing their first- and best-in-classpotential in asthma. Our collective data at the meeting underscores our commitment and progress to improving the lives of patients suffering from devastating respiratory diseases."

Dupixent

Notable presentations include new findings from the pivotal phase 3 Dupixent COPD program (NOTUS and BOREAS studies), which showed significant reduction in COPD exacerbations and improvements in lung function. Additionally, research from the VESTIGE phase 4 study, a novel imaging study evaluating the effects of Dupixent on lung function in adult patients with uncontrolled moderate-to-severe asthma, will be featured as a late-breaking oral

1/6

presentation. Lastly, multiple poster presentations demonstrate the impact of Dupixent on asthma.

Clinical data in COPD

NOTUS study: detailed efficacy and safety results from the NOTUS phase 3 study evaluating Dupixent in patients with uncontrolled COPD and evidence of type 2 inflammation will be featured in a late-breaking oral presentation. Positive topline data from the study, which showed that Dupixent significantly reduced exacerbations, were previously announcedin November 2023.
BOREAS study: findings across six abstracts from the BOREAS phase 3 study will be shared, including an analysis evaluating the treatment-by-biomarker interaction effects in patients with COPD, which will be presented in an oral abstract session as well as data on lung function.

Clinical data in uncontrolled moderate-to-severe asthma

VESTIGE clinical study: an oral abstract session will feature data on the effect of Dupixent on airway inflammation and mucus plugging in adults with uncontrolled moderate-to-severe asthma.
LIBERTY and VOYAGE studies: additional post-hoc analyses will be shared, including evaluating the impact of asthma duration on the efficacy of Dupixent in patients with uncontrolled moderate-to-severe asthma, clinical outcomes in patients with uncontrolled moderate-to-severe asthma who received Dupixent as an add-on to medium-dose inhaled corticosteroid, and the efficacy of Dupixent amongst children aged 6-11 with uncontrolled moderate-to-severe asthma.

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

Respiratory pipeline

Presentations include data for investigational compounds rilzabrutinib, an oral BTK inhibitor, and lunsekimig, a new IL-13/TSLP Nanobody VHH, in asthma.

Phase 2b study of rilzabrutinib: a poster presentation will show the impact of treatment with rilzabrutinib on loss of asthma control (LOAC) events, asthma symptoms and quality of life in patients with moderate-to-severe asthma.
Lunsekimig: an oral presentation will show the impact of lunsekimig on multiple pathological immune cell populations and epithelial cell subpopulations.

Complete List of ATS 2024 presentations:

Presenting author	Abstract title	Presentation details
COPD
Bafadhel	Dupilumab Does Not Impact Blood Eosinophil	7498
	Levels in Patients with Moderate-to-Severe	Poster Presentation
	COPD and Type 2 Inflammation: From the Phase	Sunday, May 19
	3 Boreas Trial	9:15 - 11:15 AM PDT
Bhatt	A 3-year Descriptive Assessment of	P584
	Exacerbations and Double/Triple Inhaler Use	Poster Presentation
		Monday, May 20
		2/6

	among chronic obstructive pulmonary disease
	(COPD) patients in the United States (US)
Bhatt	Characterization of Chronic Obstructive
	Pulmonary Disease (COPD) in the United States
Bhatt	Efficacy and Safety of Dupilumab in Patients
	With Moderate-to-Severe COPD and Type 2
	Inflammation: Phase 3 NOTUS Trial
Bhatt	In the Phase 3 BOREAS Trial, Dupilumab
	Reduced FeNO Levels Over Time in Patients with
	Moderate-To-Severe COPD with Type 2
	Inflammation
Buhl/Vogelmeier	Clinical and Economic Burden of COPD in
	Patients Poorly Controlled on LABA/LAMA or
	Inhaled Triple Therapy in Germany - A
	Retrospective Claims Data Analysis
Christenson	Dupilumab Increases the Proportion of Patients
	With Fractional Exhaled Nitric Oxide Levels <20
	ppb Over Time in Patients With Moderate-to-
	Severe Chronic Obstructive Pulmonary Disease
	and Type 2 Inflammation: From Phase 3
	BOREAS
Christenson	In the Phase 3 BOREAS Trial, Baseline Blood
	Eosinophils and Baseline Fractional Exhaled
	Nitric Oxide Levels Predict the Response to
	Dupilumab in Patients with Moderate-to-Severe
	Chronic Obstructive Pulmonary Disease and Type
	2 Inflammation
Hanania	Dupilumab Improves Post-Bronchodilator Lung
	Function in Patients with Moderate-to-Severe
	Chronic Obstructive Pulmonary Disease (COPD)
	with Type 2 Inflammation: Data from The Phase
	3 BOREAS Trial
Heble	Treatment And Disease Burden Among Patients
	With Moderate Or Severe COPD: Real World
	Study
Mularski	Association Between Serial Spirometric Improver
	Phenotype (Improved FEV1 Over Time) Versus
	Decliner Phenotype in Healthcare Utilization in
	Chronic Obstructive Pulmonary Disease
Papi	Dupilumab Improves Pre-Bronchodilator Lung
	Function Measures in Patients with Chronic
	Obstructive Pulmonary Disease (COPD) with
	Type 2 Inflammation: Data from The Phase 3
	BOREAS Trial
Qureshi	Healthcare Resource Utilization and Disease
	Burden in Chronic Obstructive Pulmonary
	Disease (COPD) Patients With Type 2

11:30 AM - 1:15 PM PDT

P585

Poster Presentation Monday, May 20 11:30 AM - 1:15 PM PDT

15018

Oral Presentation Monday, May 20 9:15 - 11:15 AM PDT 7547

Poster Presentation Sunday, May 19 9:15 - 11:15 AM PDT P583

Poster Presentation Monday, May 20 11:30 AM - 1:15 PM PDT

7636

Poster Presentation Monday, May 20 11:30 AM - 1:15 PM PDT

7654

Oral Presentation Tuesday, May 21 2:15 - 4:15 PM PDT

7422

Poster Presentation Sunday, May 19 9:15 - 11:15 AM PDT

P604

Poster Presentation Monday, May 20 11:30 AM - 1:15 PM PDT

P133

Poster Presentation Sunday, May 19 11:30 AM - 1:15 PM PDT

7401

Poster Presentation Sunday, May 19 9:15 - 11:15 AM PDT

713

Poster Presentation Sunday, May 19

3/6

	Inflammation in the United States: Real-world
Asthma	Evidence

Washko	Effect of Dupilumab on Airway Oscillometry,
	Ventilation/Perfusion, and Mucus Plugging in
	Moderate-to-Severe Asthma: The Vestige Trial
Bacharier	Improved Lung Function Is Associated With
	Better Asthma Control in Children With
	Moderate-To-Severe Type 2 Asthma: VOYAGE
	Study
Bourdin	Dupilumab Asthma ADVANTAGE-EU:Real-World
	Evidence on the Association Between Dupilumab
	and Use of Corticosteroid and Asthma
	Exacerbations in Patients with Severe Asthma in
	Europe
Busse	Dupilumab Add-On to Medium-Dose Inhaled
	Corticosteroid (ICS) Increases Odds of Asthma
	Control and Reduces FeNO Compared With
	Placebo Add-On to High-Dose ICS
Busse	Dupilumab Reduces Severe Exacerbations and
	Improves Lung Function in Patients with Type 2
	Asthma Irrespective of Asthma Duration
Do	Characterization of Patients with Severe Asthma
	Who Initiated Biologic Treatment Within ≤90 and
	>90 days After Biologic Eligibility
Jackson	Dupilumab Efficacy by Baseline Disease Severity
	Among Children with Uncontrolled Moderate-to-
	severe Asthma: Post-hoc Results from the
	Randomized, Placebo-controlled VOYAGE Trial
Lipworth	Improved Lung Function Is Associated With
	Better Asthma Control in Adolescents and Adults
	Aged 12 Years and Older With Moderate-to-
	Severe Type 2 Asthma: A Post hoc Analysis of
	QUEST
Pavord	Impact of Early Transient Increase in Eosinophil
	Count on the Long-Term Efficacy of Dupilumab
	in Patients With Moderate-to-Severe Asthma:
	LIBERTY ASTHMA TRAVERSE
Porsbjerg	Effect of Dupilumab Treatment on Mucus
	Plugging and Mucus Volume in Type 2 Asthma:
	The Phase 4 VESTIGE Trial
Laidlaw	Efficacy and Safety of Rilzabrutinib - A Novel
	Oral Treatment in Asthma: Results From a
	Double Blind Placebo Controlled Phase 2b Study

2:15 - 4:15 PM PDT

14998

Oral Presentation Monday, May 20 9:51 - 10:03 AM PDT 8324