AstraZeneca unveils latest research across key respiratory and immune-mediated diseases at ATS 2024 showcasing strength of its broad pipeline and portfolio

New data for Tezspire and Breztri demonstrate AstraZeneca’s innovation and commitment to transform care in COPD.

AstraZeneca will showcase new 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 Diego, CA from 17 to 22 May 2024. The company will present 59 abstracts, including 12 late-breaking posters, with a focus on unmet needs in chronic obstructive pulmonary disease (COPD), severe asthma and eosinophilic granulomatosis with polyangiitis (EGPA), as well as other chronic respiratory diseases.

Sharon Barr, Ph.D, Executive Vice President, BioPharmaceuticals R&D, AstraZeneca, said: “Data at ATS demonstrate our progress in advancing a new wave of innovative treatments, moving beyond symptom control into disease modification, remission and one day, potentially cure. Today, COPD patients have highly limited options if their disease is uncontrolled on inhaled medicines. We’re encouraged by the results of the COURSE Phase IIa data exploring tezepelumab in a broad population of COPD patients beyond those with baseline blood eosinophils above 300 cells/μL and look forward to these data being presented at the ATS International Conference.”

Ruud Dobber, Ph.D, Executive Vice President and President, BioPharmaceuticals Business Unit, AstraZeneca, said: “Our broad pipeline and portfolio of inhaled and biologic medicines are the cornerstone of our bold ambition to transform respiratory care. COPD remains one of the leading causes of death globally, and at ATS we will present important real-world evidence reinforcing the need to address cardiopulmonary risk in COPD as well as the potential for our inhaled triple therapy Breztri to reduce this risk.”

Highlights of AstraZeneca data at ATS 2024 include:

Leading transformation in COPD care by investigating novel biologic medicines, targeting key drivers across a broad range of patients including: Tezspire (tezepelumab) beyond severe asthma targeting thymic stromal lymphopoietin (TSLP) and tozorakimab, to reduce excess inflammation and epithelial remodelling in IL-33 driven disease

• COURSE Phase IIa trial: late-breaking data from a proof-of-concept trial investigating tezepelumab in moderate to very severe COPD patients. Importantly this trial included COPD patients irrespective of inflammatory drivers, baseline blood eosinophil levels, emphysema, chronic bronchitis, and smoking status.¹
• New mechanistic data from tozorakimab investigating its ability to inhibit IL-33ox biologic effects and block the RAGE-EGFR pathway vs. other IL-33 antibodies.²

Investigating the effect of inhaled triple therapy, Breztri (budesonide/glycopyrrolate/formoterol fumarate, BGF), on cardiopulmonary outcomes and deepening insights into the connection between COPD and cardiopulmonary risk

• ETHOS Phase III trial post-hoc analysis of cardiopulmonary outcomes: the new analysis explores the effect of BGF across a range of cardiopulmonary outcomes beyond traditional COPD endpoints.³
• SKOPOS-MAZI retrospective analysis: the study will provide new real-world evidence comparing mortality rates in patients who start therapy with BGF single inhaler triple therapy (SITT), versus multiple inhaler triple therapy (MITT) [open combination triple therapies (ICS/LABA+ LAMA or LABA/LAMA + ICS)] among patients with COPD in the US.⁴

• EXACOS-CV multi-country retrospective cohort study: late-breaking real-world data across 8 countries, from over 1 million patients with COPD explores the risk of serious cardiovascular events or death following a COPD exacerbation. These data add to the growing body of evidence demonstrating the importance of proactively addressing cardiopulmonary risk in COPD patients.⁵

In asthma, advancing the science in asthma rescue with Airsupra (albuterol-budesonide), a first-in-class anti-inflammatory rescue therapy for asthma in the US⁶

• MANDALA Phase III post-hoc analysis: new efficacy data for as-needed Airsupra by baseline blood eosinophil count in patients with moderate-to-severe asthma.⁷
• ACADIA trial design: outlining innovative approaches to study design for the ACADIA study of Airsupra in adolescents.⁸

Early pipeline science exploring innovative modalities including novel inhaled medicines for moderate-severe add-on treatment (“pre-biologics”) to reach a broader population of patients

• Two potential first-in-class pre-biologic medicines being explored in asthma:
  • New Phase I safety and efficacy data for AZD8630/AMG 104, an inhaled TSLP inhibitor in patients with moderate-to-severe asthma.⁹
  • Findings from a preclinical study of AZD4604, an inhaled, small molecule selective Janus Kinase 1 (JAK1) inhibitor in development for the treatment of moderate-to-severe asthma. The data explores JAK selectivity and implications for clinical inhibition compared to other currently marketed JAK inhibitors.¹⁰

Additional AstraZeneca presentations of note include results from the MANDARA Phase III trial for patients with EGPA. A highlight of the MANDARA data is the impact of Fasenra (benralizumab) to reduce or completely eliminate oral glucocorticoid use in these patients.¹¹

Key AstraZeneca presentations during ATS 2024:

Presenting author	Abstract title	Presentation details
Tezspire (tezepelumab)
Singh D	Tezepelumab in adults with moderate to very severe chronic obstructive pulmonary disease (COPD): efficacy and safety from the Phase 2a COURSE study	705Poster Session A101Sunday 19 May2:15 PM – 4:15 PM
Singh D	Tezepelumab in adults with moderate to very severe chronic obstructive pulmonary disease (COPD): efficacy and safety from the Phase 2a COURSE study	Late Breaking Mini Symposium Session B13Ballroom 20AMonday 20 May9:15 AM – 11:15 AM
Lugogo NL	A Phase 4, single-arm, open-label study to evaluate the effectiveness and safety of tezepelumab in patients with severe asthma, including underrepresented racial and clinical groups: Initial baseline demographics and clinical characteristics from the PASSAGE study	P646Thematic Poster Session C34Tuesday 21 May11:30 AM – 1:15 PM
Lugogo NL	Clinical responses to tezepelumab in patients with severe, uncontrolled asthma and history of nasal polyps from the NAVIGATOR study	P595Thematic Poster Session C31Tuesday 21 May11:30 AM – 1:15 PM
Breztri Aerosphere (budesonide/glycopyrrolate/formoterol fumarate)
Singh D	Effect of triple inhaled therapy with budesonide/glycopyrrolate/formoterol fumarate on cardiopulmonary events in chronic obstructive pulmonary disease: a post-hoc analysis of ETHOS	913Poster discussion A27Sunday 19 May9:15 AM – 11:15 AM
Marshall J	In silico lung deposition profiles of three single-inhaler triple therapy combinations assessed with functional respiratory imaging (FRI) at a low inspiratory flow rate	919Poster discussion A27Sunday 19 May9:15 AM – 11:15 AM
Pollack M	Association between severe cardiovascular events and time following exacerbations of COPD: meta-analyses of EXACOS-CV observational studies from 8 countries	P159Thematic Poster Session A48Sunday 19 May11:30 AM – 1:15 PM
Pollack M	Reduced risk of mortality for COPD patients associated with initiation of treatment with single inhaler triple therapy (budesonide/glycopyrrolate/formoterol) versus multiple inhaler triple therapy in the United States: the MAZI study	P626Thematic Poster Session B52Monday 20 May11:30 AM – 1:15 PM
Fasenra (benralizumab)
Jackson DJ	Systematic literature review of real-world outcomes of benralizumab in eosinophilic granulomatosis with polyangiitis	P655Thematic Poster Session C34Tuesday 21 May11:30 AM – 1:15 PM
Pitrez PM	Impact of disease, use of biologics and clinical remission in severe asthma: insights from a multicenter longitudinal real-life registry in Brazil	P638Thematic Poster Session C34Tuesday 21 May11:30 AM – 1:15 PM
Nair P	Effect of benralizumab versus mepolizumab on reduction in oral glucocorticoid use in patients with eosinophilic granulomatosis with polyangiitis: Phase 3 MANDARA study	314RAPiD Poster Discussion Session C102Tuesday 21 May2:15 PM – 4:15 PM
Airsupra (albuterol/budesonide)
Papi A	Efficacy of as-needed albuterol-budesonide by baseline blood eosinophil count in patients greater than or equal to 18 years with moderate-to-severe asthma	P604Thematic Poster Session C31Tuesday 21 May11:30 AM – 1:15 PM
Bacharier LB	A Bayesian dynamic borrowing approach to evaluate the efficacy of albuterol-budesonide as needed in adolescents with asthma: design of the ACADIA study	P616Thematic Poster Session C31Tuesday 21 May11:30 AM – 1:15 PM
Asthma
Lanz MJ	Comparative burden of disease associated with short-acting beta2-agonist and systemic corticosteroid exposures in US children, adolescents, and adults with asthma	302RAPiD Poster Discussion C102Tuesday 21 May2:15 PM – 4:15 PM
Early Respiratory & Immunology
Doffman S	Phase 1 safety and efficacy of AZD8630/AMG 104 inhaled anti-TSLP in healthy volunteers and patients with asthma on medium-high dose inhaled corticosteroid (ICS) and long-acting beta-agonist (LABA) with elevated baseline fractional exhaled nitric oxide (FeNO)	P406Thematic Poster Session A34Sunday 19 May11:30 AM – 1:15 PM
Riff C	Inhaled AZD4604: local Janus Kinase 1 inhibition without systemic activity	P297Thematic Poster Session B71Monday 20 May11:30 AM – 1:15 PM
Cohen S	Distinct pharmacological profiles of IL-33 antibodies	P594Thematic Poster Session B32Monday 20 May11:30 AM – 1:15 PM
Ritchie AI	Structural predictors of lung function decline in the British Early COPD Network (BEACON) cohort	Mini Symposium Session C99Tuesday 21 May2:51 PM – 3:03 PM
Respiratory Sustainability
Shah M	Systemic exposure bioequivalence of budesonide/glycopyrrolate/formoterol fumarate with the potential next generation propellant hydrofluoroolefin-1234ze versus hydrofluoroalkane-134a in healthy adults	P628Thematic Poster Session B52Monday 20 May11:30 AM – 1:15 PM
Bell J	EXACOS CARBON: describing the greenhouse gas emissions of healthcare resource utilization by frequency and severity of COPD exacerbation in England	P192Thematic Poster Session A54Sunday 19 May11:30 AM – 1:15 PM

Notes

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

Chronic Obstructive Pulmonary Disease (COPD)
COPD refers to a group of lung diseases, including chronic bronchitis and emphysema, that cause airflow blockage and breathing-related problems.¹² It affects an estimated 391 million people around the world and is a leading cause of death globally.^13,14

The lungs and heart are fundamentally linked and work together.¹⁵ 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.^16-20 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.^16,21-23

Severe asthma
Severe asthma is an often-debilitating, potentially fatal condition affecting up to 26 million people worldwide.^24-27 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.^24,26-28

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.^29,30 It is estimated that 118,000 people throughout the world live with EGPA.³¹

EGPA can result in damage to multiple organs, including lungs, upper airway, skin, heart, gastrointestinal tract and nerves.²⁹ 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.^29,32 Almost half (47%) of patients do not achieve remission with current treatments.³³

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.^34,35 Tezspire is approved in the US, EU, Japan and other countries for the treatment of severe asthma.^36-38

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.

In addition, Amgen is also collaborating with AstraZeneca on AMG104/AZD8630, an inhaled anti-TSLP compound currently in development for asthma. In November 2021, Amgen and AstraZeneca agreed to include AMG 104 / AZD8630 in the existing collaboration agreement. The companies share both costs and income, with no inventor royalty. AstraZeneca will be the development, manufacturing and commercial lead. AstraZeneca and Amgen will jointly commercialize AMG 104 / AZD8630 in North America, and AstraZeneca will distribute the product and book sales globally, including for the US.

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 LABA, glycopyrronium bromide, a LAMA, with budesonide, an 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 blood and tissue eosinophils in most patients via apoptosis (programmed cell death).³⁹ Fasenra is currently approved in more than 80 countries, including the US, EU, Japan, and is approved for self-administration in the US, EU and other countries. Fasenra has been prescribed to over 120,000 patients globally.⁴⁰

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

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 pMDI using AstraZeneca’s Aerosphere delivery technology.⁴¹

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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References

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2. Cohen ES, Strickson S, Scott IC, et al. Distinct pharmacology profiles of IL-33 antibodies. [Thematic Poster Session]. Presented at the American Thoracic Society International Conference 2024 (17-22 May).
3. Singh D, Martinez FJ, Hurst JR, et al. Effect of triple inhaled therapy with budesonide/glycopyrrolate/formoterol fumarate on cardiopulmonary events in chronic obstructive pulmonary disease: a post-hoc analysis of ETHOS. [Poster Discussion]. Presented at the American Thoracic Society International Conference 2024 (17-22 May).
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5. Pollack M, Nordon C, Rhodes K, et al. Association between severe cardiovascular events and time following exacerbations of COPD: meta-analyses of EXACOS-CV observational studies from 8 countries. [Thematic Poster Session]. Presented at the American Thoracic Society International Conference 2024 (17-22 May).
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