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 US[6]

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

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 (https://www.astrazeneca.com/)
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 (http://www.astrazeneca.com/) and follow the Company on social media @AstraZeneca (https://gateway.zscalertwo.net/auD?origurl=https:%2f%2fwww.linkedin.com%2fcompany%2fastrazeneca&_ordtok=Mkk3WV5DBDPmQrD4F5MGdGDMZR)

Contacts
For details on how to contact the Investor Relations Team, please click here (https://www.astrazeneca.com/investor-relations.html#Contacts). For Media contacts, click here (https://www.astrazeneca.com/media-centre/contacts.html).

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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