AstraZeneca will present new clinical and real-world data across its leading inhaled, biologic and early science respiratory portfolio at the European Respiratory Society (ERS) International Congress 2023, in Milan, Italy from 9-13 September 2023. The company will present 93 abstracts, including 18 oral presentations, which will focus on unmet needs in severe asthma and chronic obstructive pulmonary disease (COPD) and other acute respiratory diseases.

Ruud Dobber, Executive Vice President, BioPharmaceuticals Business Unit, AstraZeneca, said: "Unlike many other immune-mediated diseases, remission is not a well-established treatment goal in asthma. Key data presented at ERS investigate Fasenra's and Tezspire's potential to achieve remission in asthma, elevating care and further improving patient lives. Across our data we will showcase the significant steps we've made towards transforming care in asthma, COPD and other respiratory diseases."

The definition of clinical remission as a treatment goal in severe asthma generally includes the following criteria: no exacerbations, no maintenance oral corticosteroid use, stable lung function and sustained absence of significant asthma symptoms.[1]

• SHAMAL Phase IV trial: the late-breaking presentation is the first-ever trial to investigate the potential of a targeted biologic treatment to enable a significant step down of inhaled corticosteroid (ICS) therapy in severe asthma patients.[3]
• BORA Phase III extension trial and real-world XALOC programme: separate analyses will support clinical remission as an achievable and sustainable goal for patients with SEA over two years of treatment with Fasenra.[4,5]
• MIRACLE Phase III trial: late-breaking data will evaluate the efficacy and safety of Fasenra among patients with uncontrolled SEA in China and other Asian countries, where the condition is largely underdiagnosed and undertreated.[6,7] High-level results from the trial demonstrated a clinically and statistically significant reduction in asthma exacerbation rate.[8]

• DESTINATION Phase III post-hoc exploratory analysis: the analysis shows Tezspire's ability to deliver sustained remission vs. placebo over a two-year period in a broad patient population with no phenotype or biomarker limitations.[9]
• Off treatment DESTINATION Phase III extension: this analysis demonstrates that the sustained effects of Tezspire gradually decrease after stopping treatment with neither the biomarkers nor the clinical effects returning to baseline after nine months since last dose. The results show the importance of long-term use of Tezspire.[10]

• EXACOS-CV multi-country retrospective cohort study: new real-world data from over 300,000 patients with COPD demonstrate that patients who experienced an exacerbation had an increased risk of serious cardiovascular events in the first six months, and this risk remained elevated for one year.[11][ ]These data highlight the importance of preventing COPD exacerbations to reduce cardiopulmonary risk and mortality.[12  ]

• Cytokine, interleukin-33 (IL-33) research: new efficacy and safety results from the ACCORD-2 Phase IIa trial will add to the growing evidence for tozorakimab, an IL-33 neutralising monoclonal antibody, as a potential treatment option for patients hospitalised with COVID-19.[13,14]

• Exploratory research will be shared demonstrating the potential of a new platform to investigate IL-33 biology and screen novel therapies.[15]

• Early COPD research: new approaches to identify biological drivers of early COPD disease to improve earlier diagnosis.[16]

Key AstraZeneca presentations during ERS 2023:
 

Presenting Abstract title Presentation details
author
 
Fasenra
(benralizumab)
Jackson, D SHAMAL: reduction of RCT798
maintenance inhaled Oral Presentation
corticosteroids in 10 September 2023
patients with severe 10:29 - 10:36 CEST
eosinophilic asthma
treated with benralizumab:
a randomised phase 4 study
Lommatzsch, M Durability of benralizumab OA1420   
-induced remission in Oral Presentation
severe asthma: an analysis 10 September 2023
of the BORA study 14:55 - 15:00 CEST
Pelaia, G Patients with severe PA4131
eosinophilic asthma Poster Session
achieved remission over 2 12 September 2023
years with benralizumab: 08:00 - 09:30 CEST
Integrated analysis of the
>1000-patient,
multinational, real-world
XALOC-1 study
Lai, K Efficacy and safety of PA4130
benralizumab in patients Poster Session
with severe uncontrolled 12 September 2023
asthma despite ICS-LABA: a 08:00 - 09:30 CEST
randomised, double-blind,
placebo-controlled phase 3
trial in Asia (MIRACLE) 
Tezspire
(tezepelumab)
Brightling, C Biomarkers and clinical OA1415   
outcomes after cessation Oral Presentation10 September 2023
of tezepelumab after 2 14:30 - 14:35 CEST
years of treatment  
(DESTINATION)
Wechsler, ME On-treatment clinical PA4722
remission with tezepelumab Poster Session
in patients with severe, 12 September 2023
uncontrolled asthma in the 12:30 - 14:00 CEST
phase 3 DESTINATION study  
COPD
Vogelmeier, C Increased risk of severe PA3013
cardiovascular events Poster Session
following exacerbations of 11 September 2023
COPD: a multi-database 12:30 - 14:00 CEST
cohort study  
Carter, V COPD exacerbations during PA1014
and beyond the COVID-19 Poster Session
pandemic in the UK 10 September 2023
12:30 - 14:00 CEST
 
Breztri
Aerosphere
(budesonide/gly
copyrrolate/for
moterol
fumarate)
Müllerová, H Medication success among PA1319
real-world users of Poster Session
budesonide/glycopyrrolate/f 10 September 2023
ormoterol fumarate (BGF) 12:30 - 14:00 CEST
for the management of COPD
in a UK primary care
population
Singh, D Step up to ICS/LAMA/LABA PA4687
vs switch to LAMA/LABA in Poster Session
patients with COPD on 12 September 2023
ICS/LABA: post hoc 12:30 - 14:00 CEST
analysis of KRONOS
Takahashi, K Characteristics of COPD PA4706
patients initiating Poster Session
budesonide/glycopyrronium/f 12 September 2023
ormoterol (BGF) and other 12:30 - 14:00 CEST
triple therapy in Japan: a
health-care claims-based
real-world database study
(MITOS program)
 
Early
Respiratory &
Immunology
Pandya, H Tozorakimab in patients PA1690
hospitalised with COVID Poster Session
-19: a phase 2, randomised 10 September 2023
adaptive platform study 16:00 - 17:30 CEST
(ACCORD-2)
 
Nys, J Development of a huPCLS PA1853
platform to explore IL-33 Poster Session
biology and test novel 10 September 2023
therapies 16:00 - 17:30 CEST
Ritchie, A Characterising PA4144
radiological abnormalities Poster Session
in Early COPD 12 September 2023
08:00 - 09:30 CEST
Respiratory
Sustainability
Winders, T Consensus quality standard PA4607
for implementing inhaler Poster Session
regimen switch in patients 12 September 2023
with respiratory disease 12:30 - 14:00 CEST

Notes

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

Severe asthma
Severe asthma is an often-debilitating, potentially fatal condition affecting up to 26 million people worldwide.[17-20] 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.[17,19-21 ]

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 the third leading cause of death globally.[22,23]

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).[24] Fasenra is currently approved as an add-on maintenance treatment for severe eosinophilic asthma in the US, EU, Japan and other countries, and is approved for self-administration in the US, EU and other countries. Results from the MIRACLE Phase III trial will support our application for the review of Fasenra as a treatment for severe asthma to the China National Medical Products Administration (NMPA).

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.[25,26] Tezspire is approved in the US, EU, Japan and other countries for the treatment of severe asthma.[27-29]

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.

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.

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 (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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3. Jackson D, et al. SHAMAL: Reduction of Maintenance Inhaled Corticosteroids in Patients with Severe Eosinophilic Asthma Treated with Benralizumab: A Randomised Phase 4 Study. [Oral Presentation]. Presented at the European Respiratory Society (ERS) International Congress 2023 (9-13 September).
4. Lommatzsch, M, et al. Durability of Benralizumab-induced remission in severe asthma: an analysis of the BORA study [Oral Presentation]. Presented at the European Respiratory Society (ERS) International Congress 2023 (9-13 September).
5. Pelaia, G, et al. Patients with severe eosinophilic asthma achieved remission over 2 years with benralizumab: Integrated analysis of the >1000-patient, multinational, real-world XALOC-1 study [Poster Session]. Presented at the European Respiratory Society (ERS) International Congress 2023 (9-13 September).
6. Lai, K, et al. Efficacy and safety of benralizumab in patients with severe uncontrolled asthma despite ICS-LABA: a randomised, double-blind, placebo-controlled phase 3 trial in Asia (MIRACLE) [Poster Session]. Presented at the European Respiratory Society (ERS) International Congress 2023 (9-13 September).
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10. Brightling, C, et al. Biomarkers and clinical outcomes after cessation of tezepelumab after 2 years of treatment (DESTINATION) [Oral Presentation]. Presented at the European Respiratory Society (ERS) International Congress 2023 (9-13 September).
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