AstraZeneca to showcase latest research on comprehensive portfolio and pipeline aimed at transforming respiratory diseases at ATS 2025

New data for AIRSUPRA and BREZTRI highlight progress in advancing asthma and COPD care globally

WILMINGTON, Del.--(BUSINESS WIRE)--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 May 16 to 21, 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 annualized 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 modeling 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 TEZSPIRE’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 program: 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 hospitalized 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 colonization, 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:

INDICATIONS AND LIMITATIONS OF USE / ISI

AIRSUPRA^® (albuterol and budesonide)

• Contraindications: Hypersensitivity to albuterol, budesonide, or to any of the excipients
• Deterioration of Asthma: Asthma may deteriorate acutely over a period of hours or chronically over several days or longer. If the patient continues to experience symptoms after using AIRSUPRA or requires more doses of AIRSUPRA than usual, it may be a marker of destabilization of asthma and requires evaluation of the patient and their treatment regimen
• Paradoxical Bronchospasm: AIRSUPRA can produce paradoxical bronchospasm, which may be life threatening. Discontinue AIRSUPRA immediately and institute alternative therapy if paradoxical bronchospasm occurs. It should be recognized that paradoxical bronchospasm, when associated with inhaled formulations, frequently occurs with the first use of a new canister
• Cardiovascular Effects: AIRSUPRA, like other drugs containing beta₂-adrenergic agonists, can produce clinically significant cardiovascular effects in some patients, as measured by pulse rate, blood pressure, and/or other symptoms. If such effects occur, AIRSUPRA may need to be discontinued. In addition, beta-agonists have been reported to produce electrocardiogram (ECG) changes, such as flattening of the T wave, prolongation of the QTc interval, and ST-segment depression. Therefore, AIRSUPRA, like all sympathomimetic amines, should be used with caution in patients with cardiovascular disorders, especially coronary insufficiency, cardiac arrhythmias, and hypertension
• Do Not Exceed Recommended Dose: Clinically significant cardiovascular effects and fatalities have been reported in association with excessive use of inhaled sympathomimetic drugs
• Hypersensitivity Reactions, Including Anaphylaxis: Can occur after administration of albuterol sulfate and budesonide, components of AIRSUPRA, as demonstrated by cases of anaphylaxis, angioedema, bronchospasm, oropharyngeal edema, rash, and urticaria. Discontinue AIRSUPRA if such reactions occur
• Risk of Sympathomimetic Amines with Certain Coexisting Conditions: AIRSUPRA, like all therapies containing sympathomimetic amines, should be used with caution in patients with convulsive disorders, hyperthyroidism, or diabetes mellitus and in patients who are unusually responsive to sympathomimetic amines
• Hypokalemia: Beta-adrenergic agonist medicines may produce significant hypokalemia in some patients. The decrease in serum potassium is usually transient, not requiring supplementation
• Immunosuppression and Risk of Infections: Due to possible immunosuppression from the use of inhaled corticosteroids (ICS), potential worsening of infections could occur. Use with caution. A more serious or fatal course of chickenpox or measles can occur in susceptible patients
• Oropharyngeal Candidiasis: Has occurred in patients treated with ICS agents. Monitor patients periodically. Advise patients to rinse his/her mouth with water, if available, without swallowing after inhalation
• Hypercorticism and Adrenal Suppression: May occur with very high doses in susceptible individuals. If such changes occur, consider appropriate therapy
• Reduction in Bone Mineral Density: Decreases in bone mineral density have been observed with long-term administration of ICS. For patients at high risk for decreased bone mineral density, assess initially and periodically thereafter
• Glaucoma and Cataracts: Have been reported following the long-term administration of ICS, including budesonide, a component of AIRSUPRA
• Effects on Growth: Orally inhaled corticosteroids, including budesonide, may cause a reduction in growth velocity when administered to pediatric patients. The safety and effectiveness of AIRSUPRA have not been established in pediatric patients, and AIRSUPRA is not indicated for use in this population
• Most common adverse reactions (incidence ≥ 1%) are headache, oral candidiasis, cough, and dysphonia
• Drug Interactions: AIRSUPRA should be administered with caution to patients being treated with:
  • Strong cytochrome P450 3A4 inhibitors (may cause systemic corticosteroid effects)
  • Short-acting bronchodilators (concomitant use of additional beta-agonists with AIRSUPRA should be used judiciously to prevent beta-agonist overdose)
  • Beta-blockers (may block pulmonary effects of beta-agonists and produce severe bronchospasm)
  • Diuretics or non-potassium-sparing diuretics (may potentiate hypokalemia or ECG changes). Consider monitoring potassium levels
  • Digoxin (may decrease serum digoxin levels). Consider monitoring digoxin levels
  • Monoamine oxidase inhibitors (MAOI) or tricyclic antidepressants (Use AIRSUPRA with extreme caution; may potentiate effect of albuterol on the cardiovascular system)

• Use AIRSUPRA with caution in patients with hepatic impairment, as budesonide systemic exposure may increase. Monitor patients with hepatic disease

INDICATION
AIRSUPRA is a combination of albuterol, a beta₂-adrenergic agonist and budesonide, a corticosteroid, indicated for the as-needed treatment or prevention of bronchoconstriction and to reduce the risk of exacerbations in patients with asthma 18 years of age and older.

Please see full Prescribing Information, including Patient Information.

You may report side effects related to AstraZeneca products.

BREZTRI AEROSPHERE^® (budesonide, glycopyrrolate, and formoterol fumarate) Inhalation Aerosol

• BREZTRI is contraindicated in patients who have a hypersensitivity to budesonide, glycopyrrolate, formoterol fumarate, or product excipients
• BREZTRI is not indicated for treatment of asthma. Long-acting beta2-adrenergic agonist (LABA) monotherapy for asthma is associated with an increased risk of asthma-related death. These findings are considered a class effect of LABA monotherapy. When a LABA is used in fixed-dose combination with ICS, data from large clinical trials do not show a significant increase in the risk of serious asthma-related events (hospitalizations, intubations, death) compared with ICS alone. Available data do not suggest an increased risk of death with use of LABA in patients with COPD
• BREZTRI should not be initiated in patients with acutely deteriorating COPD, which may be a life-threatening condition
• BREZTRI is NOT a rescue inhaler. Do NOT use to relieve acute symptoms; treat with an inhaled short-acting beta2-agonist
• BREZTRI should not be used more often than recommended; at higher doses than recommended; or in combination with LABA-containing medicines, due to risk of overdose. Clinically significant cardiovascular effects and fatalities have been reported in association with excessive use of inhaled sympathomimetic drugs
• Oropharyngeal candidiasis has occurred in patients treated with orally inhaled drug products containing budesonide. Advise patients to rinse their mouths with water without swallowing after inhalation
• Lower respiratory tract infections, including pneumonia, have been reported following ICS. Physicians should remain vigilant for the possible development of pneumonia in patients with COPD as the clinical features of pneumonia and exacerbations frequently overlap
• Due to possible immunosuppression, potential worsening of infections could occur. Use with caution. A more serious or fatal course of chickenpox or measles can occur in susceptible patients
• Particular care is needed for patients transferred from systemic corticosteroids to ICS because deaths due to adrenal insufficiency have occurred in patients during and after transfer. Taper patients slowly from systemic corticosteroids if transferring to BREZTRI
• Hypercorticism and adrenal suppression may occur with regular or very high dosage in susceptible individuals. If such changes occur, consider appropriate therapy
• Caution should be exercised when considering the coadministration of BREZTRI with long-term ketoconazole and other known strong CYP3A4 Inhibitors. Adverse effects related to increased systemic exposure to budesonide may occur
• If paradoxical bronchospasm occurs, discontinue BREZTRI immediately and institute alternative therapy
• Anaphylaxis and other hypersensitivity reactions (eg, angioedema, urticaria or rash) have been reported. Discontinue and consider alternative therapy
• Use caution in patients with cardiovascular disorders, especially coronary insufficiency, as formoterol fumarate can produce a clinically significant cardiovascular effect in some patients as measured by increases in pulse rate, systolic or diastolic blood pressure, and also cardiac arrhythmias, such as supraventricular tachycardia and extrasystoles
• Decreases in bone mineral density have been observed with long-term administration of ICS. Assess initially and periodically thereafter in patients at high risk for decreased bone mineral content
• Glaucoma and cataracts may occur with long-term use of ICS. Worsening of narrow-angle glaucoma may occur, so use with caution. Consider referral to an ophthalmologist in patients who develop ocular symptoms or use BREZTRI long term. Instruct patients to contact a healthcare provider immediately if symptoms occur
• Worsening of urinary retention may occur. Use with caution in patients with prostatic hyperplasia or bladder-neck obstruction. Instruct patients to contact a healthcare provider immediately if symptoms occur
• Use caution in patients with convulsive disorders,

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