AstraZeneca will present the latest clinical and real-world data across its leading inhaled, biologic and early science respiratory portfolio at the American Thoracic Society (ATS) International Conference, in San Francisco, CA from 16 to 21 May 2025.

With more than 75 abstracts, including eight late-breakers, the Company continues to drive innovation and address unmet needs in care across all severities of asthma, chronic obstructive pulmonary disease (COPD), eosinophilic granulomatosis with polyangiitis (EGPA) and other chronic inflammatory diseases.

Ruud Dobber, Executive Vice President and President, BioPharmaceuticals Business Unit, AstraZeneca, said: "With asthma and COPD affecting hundreds of millions of people - and COPD now the third leading cause of death worldwide - our portfolio of inhaled and biologic medicines is central to achieving our bold ambition to transform respiratory care. The data we're presenting at ATS focus on important gaps in care today, including improving the treatment approach to asthma rescue medication, reducing cardiopulmonary risk in COPD and targeting the underlying mechanisms that drive a broad range of inflammatory diseases."

Sharon Barr, Executive Vice President, BioPharmaceuticals R&D, AstraZeneca, said: "Today, far too many patients with asthma remain uncontrolled in their disease. Our data at ATS demonstrate progress we've made in advancing innovative treatments, moving beyond symptom control into disease modification, remission and one day, potentially a cure. We're particularly excited by the results of the BATURA Phase IIIb trial exploring Airsupra and its potential to transform rescue treatment in asthma, and look forward to discussing the full data with the scientific community."

Through data from our inhaled portfolio, we are advancing the science in asthma and COPD for patients who remain uncontrolled on current treatments:

• Airsupra (albuterol/budesonide): Anti-inflammatory rescue treatment demonstrates potential to be the preferred rescue across all asthma severities, superior to albuterol-alone, according to guidelines outlined by Global Initiative for Asthma (GINA)

• BATURA Phase IIIb prespecified analysis: data explores the impact of as-needed Airsupra compared with albuterol-alone in reducing cumulative exposure to systemic corticosteroids in people with mild asthma.¹
• MANDALA Phase III study post-hoc analysis: this analysis explores time-to-first severe exacerbation and annualised exacerbation rate in the first 3 months post-treatment initiation with as-needed Airsupra versus albuterol-alone.²
• GRANITE study baseline characteristics: clinical characteristics of early users of Airsupra in a US claims database.³

• Breztri (budesonide/glycopyrrolate/formoterol fumarate, BGF): Enhancing our understanding of the impact on cardiopulmonary outcomes and the COPD-asthma connection with Breztri, an inhaled triple therapy

• ETHOS Phase III post-hoc analysis: the new analysis explores the estimated number needed to treat (NNT) across a range of cardiopulmonary endpoints with Breztri compared to dual long-acting muscarinic antagonists (LAMA)/long-acting beta-agonists (LABAs) therapy in patients with moderate-to-very severe COPD.⁴
• MITOS EROS+CP studies: late-breaking real-world data investigates whether prompt initiation of Breztri after a COPD exacerbation is associated with reduced subsequent COPD exacerbations and cardiopulmonary events in patients with COPD compared to delayed and very-delayed initiation strategies. Data also investigates impact of Breztri on COPD exacerbations in patients with COPD and asthma compared to delayed and very-delayed initiation strategies.^5,6
• Functional respiratory imaging (FRI) study: the first of its kind study to assess the lung deposition profile of Breztri in patients with COPD and concomitant asthma (ACO) who have persistent airflow limitation.⁷

Highlights from data across our leading biologics portfolio demonstrate efforts to target the underlying mechanisms that drive a broader range of inflammatory conditions:

• Fasenra (benralizumab): Demonstrating Fasenra's unique mechanism of action targeting and removing the source of eosinophilic inflammation across diseases

• MANDARA open label extension: two-year efficacy and safety data for the treatment of EGPA will explore remission rates with switch from mepolizumab to Fasenra and impact on oral corticosteroid (OCS) sparing.⁸
• Fasenra and depemokimab modelling comparison: results will highlight eosinophil depletion with Fasenra versus depemokimab through pharmacokinetic/pharmacodynamic (PK/PD) model simulation.⁹
• ZEPHYR-5 study: in patients with a diagnosis of asthma and concomitant COPD, a retrospective US database analysis will demonstrate the impact Fasenra has on the rate of COPD exacerbations.¹⁰

• Tezspire (tezepelumab): Advancing the science of Tezpire's unique mechanism of action targeting thymic stromal lymphopoietin (TSLP) as a key driver in a range of epithelial-driven inflammatory diseases

• WAYFINDER Phase IIIb study: data will evaluate the impact of Tezspire on OCS use in OCS-dependent patients with severe asthma.¹¹

• WAYPOINT sub-analysis: efficacy and safety data will evaluate effects of Tezspire in adults with severe chronic rhinosinusitis with nasal polyps, with and without co-morbid asthma.¹²
• COURSE Phase IIa trial: a proof-of-concept trial investigating Tezspire in moderate to very severe COPD patients irrespective of inflammatory drivers, baseline blood eosinophil levels, emphysema, chronic bronchitis and smoking status.¹³

• Tozorakimab: Demonstrating potential benefits of tozorakimab to reduce excess inflammation in IL-33 driven diseases

• FRONTIER Phase II programme: results from four studies across asthma and COPD explore tozorakimab's safety profile.¹⁴
• Retrospective cohort study on COPD exacerbations and smoking status: characteristics and outcomes of people with COPD who experience frequent/severe exacerbations while receiving inhaled triple therapy were evaluated based on their smoking status.¹⁵
• Retrospective cohort study on treatment patterns in US patients hospitalised for severe viral lower respiratory tract disease (LRTD): data will provide new insight into medication use in patients with severe viral LRTD, stratified by time period, viral etiology and clinical severity.¹⁶

• Data on our early-stage pipeline and machine learning (AI) showcase how we are deepening our understanding of new diseases through technology and exploring new pathways in COPD:

• GREAT-2 Phase II trial: efficacy and safety data will evaluate effects of gremubamab (MEDI3902) in patients with bronchiectasis and Pseudomonas aeruginosa colonisation, which is associated with increased exacerbations and poor outcomes in bronchiectasis.¹⁷
• COPD pre-clinical data: data evaluates the impact of AZD6793, a novel IRAK4 inhibitor currently undergoing clinical investigation, on multiple disease-relevant pathways in COPD.^18-20
• Deep learning-based studies: data explore how we are utilizing machine learning to predict disease progression, advancing our understanding of respiratory diseases with significant unmet medical need, including idiopathic pulmonary fibrosis (IPF)^21-23 and COPD.²⁴

Key AstraZeneca presentations during ATS 2025:

Notes

Data presented does not reflect any head-to-head comparisons.

Asthma
Asthma is a chronic, inflammatory respiratory disease with variable symptoms that affects as many as 262 million people worldwide,²⁵ including over 25 million in the US.²⁶

Patients with asthma experience recurrent breathlessness and wheezing, which varies over time, and in severity and frequency.²⁷ These patients are at risk of severe exacerbations regardless of their disease severity, adherence to treatment or level of control.^28,29 There are an estimated 136 million asthma exacerbations globally per year,³⁰ including more than 10 million in the US²⁶; these are physically threatening and emotionally significant for many patients³¹ and can be fatal.^25,32

Severe asthma is an often-debilitating, potentially fatal condition affecting up to 26 million people worldwide.^25,32-34 Patients may be uncontrolled despite high dosages of standard of care asthma controller medicines, experiencing frequent exacerbations and significant limitations on lung function and health-related quality of life as a result.^32-35

Inflammation is central to both asthma symptoms²⁸ and exacerbations.³⁶ Many patients experiencing asthma symptoms use a short-acting beta agonists (SABA) (e.g. albuterol) as a rescue medicine;^37-39 however, taking a SABA alone does not address inflammation, leaving patients at risk of severe exacerbations,⁴⁰ which can result in impaired quality of life,⁴¹ hospitalisation and frequent oral corticosteroid (OCS) use.⁴¹ Treatment of exacerbations with as few as 1-3 short courses of OCS are associated with an increased risk of adverse health conditions including type 2 diabetes, depression/anxiety, renal impairment, cataracts, cardiovascular disease, pneumonia and fracture.⁴² International recommendations from the Global Initiative for Asthma no longer recommend SABA alone as the preferred rescue therapy.²⁷

COPD
COPD refers to a group of lung diseases, including chronic bronchitis and emphysema, that cause airflow blockage and breathing-related problems.⁴³ It affects an estimated 391 million people around the world and is the third leading cause of death globally.^44,45

The lungs and heart are fundamentally linked and work together.⁴⁶ COPD mechanisms elevate the risk of both lung and heart events, including severe or even fatal COPD exacerbations and cardiac events, known as cardiopulmonary risk.^47-51 Approximately 1 in 5 patients with COPD will die within a year of their first hospitalisation for an exacerbation, and pulmonary and cardiac events are a key driver of mortality and the most common reasons for death in patients with COPD.^47,52-54

Eosinophilic granulomatosis with polyangiitis (EGPA)
EGPA, formerly known as Churg-Strauss Syndrome, is a rare, immune-mediated inflammatory disease that is caused by inflammation of small to medium-sized blood vessels.^55,56 It is estimated that 118,000 people throughout the world live with EGPA.⁵⁷

EGPA can result in damage to multiple organs, including lungs, upper airway, skin, heart, gastrointestinal tract and nerves.⁵⁵ The most common symptoms and signs include extreme fatigue, weight loss, muscle and joint pain, rashes, nerve pain, sinus and nasal symptoms, and shortness of breath. Without treatment, the disease may be fatal.^55,58 Almost half (47%) of patients do not achieve remission with current treatments.⁵⁹

Airsupra
Airsupra (albuterol/budesonide), formerly known as PT027, is a first-in-class SABA/ICS rescue treatment for asthma in the US, to be taken as needed. It is an inhaled, fixed-dose combination rescue medication containing albuterol (also known as salbutamol), a SABA, and budesonide, a corticosteroid, and has been developed in a pressurised metered-dose inhaler (pMDI) using AstraZeneca's Aerosphere delivery technology.⁶⁰

Outside of the US, Airsupra is also approved in the United Arab Emirates, Kuwait, Bahrain, Qatar and Oman. 

Breztri/Trixeo Aerosphere

Breztri Aerosphere (budesonide/glycopyrronium/formoterol fumarate), approved under the brand name Trixeo in the EU, is a single-inhaler, fixed-dose triple-combination of formoterol fumarate, a long-acting beta-agonist (LABA), glycopyrronium bromide, a long-acting muscarinic antagonists (LAMA, with budesonide, an inhaled corticosteriod (ICS), and delivered via the Aerosphere pressurised metered-dose inhaler. Breztri Aerosphere is approved to treat COPD in more than 50 countries worldwide including the US, EU, China and Japan, and is currently being studied in Phase III trials for asthma.

Fasenra
Fasenra (benralizumab) is a monoclonal antibody that binds directly to IL-5 receptor alpha on eosinophils and attracts natural killer cells to induce rapid and near-complete depletion of eosinophils via apoptosis (programmed cell death).⁶¹ Fasenra is currently approved as an add-on maintenance treatment for severe eosinophilic asthma in the US, EU, Japan, China and other countries, and is approved for self-administration in the US, EU and other countries.

Fasenra was developed by AstraZeneca and is in-licensed from BioWa, Inc., a wholly-owned subsidiary of Kyowa Kirin Co., Ltd., Japan.

Tezspire
Tezspire (tezepelumab) is being developed by AstraZeneca in collaboration with Amgen as a first-in-class human monoclonal antibody that inhibits the action of TSLP, a key epithelial cytokine that sits at the top of multiple inflammatory cascades and is critical in the initiation and persistence of allergic, eosinophilic and other types of airway inflammation associated with severe asthma, including airway hyperresponsiveness.^62,63 Tezspire is approved in the US, EU, Japan and other countries for the treatment of severe asthma.^65-67

Amgen collaboration

In 2020, Amgen and AstraZeneca updated a 2012 collaboration agreement for Tezspire. Both companies will continue to share costs and profits equally after payment by AstraZeneca of a mid single-digit inventor royalty to Amgen. AstraZeneca continues to lead development and Amgen continues to lead manufacturing. All aspects of the collaboration are under the oversight of joint governing bodies. Under the amended agreement, Amgen and AstraZeneca will jointly commercialise Tezspire in North America. Amgen will record product sales in the US, with AZ recording its share of US profits as Collaboration Revenue. Outside of the US, AstraZeneca will record product sales, with Amgen recording profit share as Other/Collaboration revenue.

AstraZeneca in Respiratory & Immunology
Respiratory & Immunology, part of AstraZeneca BioPharmaceuticals is a key disease area and growth driver to the Company.

AstraZeneca is an established leader in respiratory care with a 50-year heritage and a growing portfolio of medicines in immune-mediated diseases. The Company is committed to addressing the vast unmet needs of these chronic, often debilitating, diseases with a pipeline and portfolio of inhaled medicines, biologics and new modalities aimed at previously unreachable biologic targets. Our ambition is to deliver life-changing medicines that help eliminate COPD as a leading cause of death, eliminate asthma attacks and achieve clinical remission in immune-mediated diseases.

AstraZeneca
AstraZeneca (LSE/STO/Nasdaq: AZN) is a global, science-led biopharmaceutical company that focuses on the discovery, development, and commercialisation of prescription medicines in Oncology, Rare Diseases, and BioPharmaceuticals, including Cardiovascular, Renal & Metabolism, and Respiratory & Immunology. Based in Cambridge, UK, AstraZeneca operates in over 100 countries and its innovative medicines are used by millions of patients worldwide. Please visit astrazeneca.com and follow the Company on social media @AstraZeneca

Contacts
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