AstraZeneca is advancing clinical practice in respiratory medicine with new data at the American Thoracic Society 2018 International Congress

Phase III SYGMA trials investigated the value of Symbicort Turbuhaler taken as an anti-inflammatory reliever therapy ‘as needed’ in mild asthma

A growing body of evidence on Fasenra’s role in severe eosinophilic asthma supports improved identification of suitable patients

AstraZeneca and MedImmune, its global biologics research and development arm, will present updates from its respiratory medicines and pipeline at the American Thoracic Society (ATS) 2018 International Congress, 18-23 May in San Diego, US. The breadth and depth of science are reflected in the 60 accepted abstracts, including five oral presentations, which focus on key areas of unmet need in asthma and chronic obstructive pulmonary disease (COPD).

Highlights include results from the two Phase III trials, SYGMA 1 and SYGMA 2, of Symbicort Turbuhaler (budesonide/formoterol) in mild asthma which will be presented as late-breaking abstracts on Sunday 20 May. Additionally, eight abstracts, including one late-breaking abstract, underscore the growing body of evidence on Fasenra (benralizumab), and the role of this new medicine for patients with severe eosinophilic asthma.

Tom Keith-Roach, Vice President, Respiratory at AstraZeneca, said: “The wealth of data demonstrates our commitment to advancing clinical practice across inhaled combinations and biologics. The SYGMA trial investigated the potential role of Symbicort Turbuhaler taken as an anti-inflammatory reliever in mild asthma, a condition which impacts millions of patients. Following the launch of Fasenra in 2017, new data will support physicians in selecting patients with severe eosinophilic asthma who are more likely to respond to this new biologic medicine.”

AstraZeneca and MedImmune key presentations at ATS 2018 include:

Symbicort Turbuhaler

• Efficacy and safety of as-needed budesonide/formoterol in mild asthma (Late-breaker Thematic Poster, poster #918, session A34)
• Severe exacerbations and inhaled corticosteroid load with as-needed budesonide/formoterol vs maintenance budesonide in mild asthma (Late-breaker, Thematic Poster, poster #917, session A34)

In the US, Symbicort is approved in the pMDI device, but not the Turbuhaler device.

Fasenra

• Influence of key clinical baseline factors on benralizumab efficacy for patients with severe, uncontrolled asthma (Late-breaker, Rapid Abstract Poster Discussion, poster #424, session A101)
• Benralizumab improves morning peak expiratory flow while reducing oral corticosteroid dosages for patients with severe, uncontrolled asthma in the ZONDA Phase III trial (Rapid Abstract Poster Discussion, poster #410, session A101)
• Impact of Body Mass Index on efficacy of benralizumab in patients with severe, uncontrolled eosinophilic asthma: pooled analysis of the SIROCCO and CALIMA trials (Rapid Abstract Poster Discussion, poster #412, session A101)
• Demographics, clinical characteristics, and response to benralizumab treatment for patients with severe, eosinophilic asthma and fixed airflow obstruction (Rapid Abstract Poster Discussion, poster #411, session A101)
• Blood eosinophil counts in adults with frequent asthma exacerbations and intensive management (Thematic Poster, poster #1112, session A53)

Bevespi and PT010

• Glycopyrrolate/formoterol fumarate fixed-dose combination delivered by metered dose inhaler improves lung function and symptoms in patients with COPD: Results from the PINNACLE-4 Study in Asia, Europe, and the USA (Rapid Abstract Poster Discussion, poster #610, session B102)

Early clinical assets and breakthrough research

Data highlighting next generation of inhaled small molecules, new drug modalities and breakthrough science addressing underlying disease biology, including:

• Phase 2a data from AZD8871, an inhaled long acting dual muscarinic antagonist/ β2 adrenoceptor agonist (MABA) under development for the treatment of COPD (Late Breaker Oral Presentation, abstract A7708, session B14)
• Lung Immunity: Discovery and Development of AZD1402 (PRS-060) a potent and selective blocker of the IL-4 receptor alpha (Thematic Poster, poster #P879, session A34)
• Lung Epithelium: New data on the role of the upstream cytokine IL-33 in Idiopathic Pulmonary Fibrosis (IPF) (Thematic Poster, poster #P287, session C72)
• Lung Regeneration: Data showing that targeting cell ageing prevents cigarette smoke-induced pulmonary emphysema. (Abstract A7633/1014, session D110)
• Novel analysis of biological differences between asthma and COPD that could shed new light on defining asthma-COPD overlap (Oral Presentation, abstract A5909)
• First report of COPD CompEx, a novel composite endpoint to accelerate early clinical development of new agents for the treatment of COPD (Rapid abstract poster discussion, abstract A7428/607, session D101)

NOTES TO EDITORS

About AstraZeneca in Respiratory Disease

Respiratory disease is one of AstraZeneca’s main therapy areas, and the Company has a growing portfolio of medicines that reached more than 18 million patients in 2017. AstraZeneca’s aim is to transform asthma and COPD treatment through inhaled combinations at the core of care, biologics for the unmet needs of specific patient populations, and scientific advancements in disease modification.

The Company is building on a 40-year heritage in respiratory disease and AstraZeneca’s capability in inhalation technology spans pressurised metered-dose inhalers and dry powder inhalers, as well as the Aerosphere Delivery Technology. The company also has a growing portfolio of respiratory biologics, including Fasenra (anti-eosinophil, anti-IL-5rɑ) now approved for severe eosinophilic asthma, and tezepelumab (anti-TSLP), which achieved its Phase IIb primary and secondary endpoints and is continuing development in the Phase III PATHFINDER clinical trial programme. AstraZeneca’s research is focused on addressing underlying disease drivers focusing on the lung epithelium, lung immunity and lung regeneration.

About MedImmune

MedImmune is the global biologics research and development arm of AstraZeneca, a global, innovation-driven biopharmaceutical business that focuses on the discovery, development and commercialisation of small molecule and biologic prescription medicines. MedImmune is pioneering innovative research and exploring novel pathways across Oncology; Respiratory, Cardiovascular & Metabolic Diseases; and Infection and Vaccines. The MedImmune headquarters is located in Gaithersburg, US., one of AstraZeneca’s three global R&D centres, with additional sites in Cambridge, UK, and Mountain View, US. For more information, please visit www.medimmune.com.

About AstraZeneca

AstraZeneca is a global, science-led biopharmaceutical company that focuses on the discovery, development and commercialisation of prescription medicines, primarily for the treatment of diseases in three therapy areas - Oncology, Cardiovascular, Renal & Metabolism and Respiratory. The Company also is selectively active in the areas of autoimmunity, neuroscience and infection. AstraZeneca operates in over 100 countries and its innovative medicines are used by millions of patients worldwide.

For more information, please visit www.astrazeneca.com and follow us on Twitter @AstraZeneca.

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