AstraZeneca to present scientific advancements from growing respiratory portfolio at the American Thoracic Society conference 2017

Phase III ZONDA trial shows the potential of benralizumab
to reduce or discontinue the use of oral corticosteroids

18 May 2017

AstraZeneca and its global biologics research and development arm, MedImmune, will present new data from its growing respiratory portfolio and pipeline at the 113th annual conference of the American Thoracic Society (ATS) in Washington, DC, USA, 19-24 May 2017.

The breadth and depth of science behind AstraZeneca’s growing respiratory portfolio and pipeline are reflected in the 59 accepted abstracts, including three oral presentations and 13 poster discussions, which will focus on the unmet needs of asthma and chronic obstructive pulmonary disease (COPD). A highlight will be the reporting of data from two new trials from the WINDWARD programme for benralizumab, AstraZeneca’s most-advanced respiratory biologic medicine.

Tom Keith-Roach, Vice President, Respiratory at AstraZeneca, said: “The data being presented at the ATS conference will reflect our commitment to advancing respiratory science in both inhaled combinations and targeted biologics for unmet patient needs. We are particularly excited to share the results of the ZONDA trial, looking at the potential for benralizumab to reduce or discontinue oral corticosteroids, which are a significant burden to many patients with severe asthma.”

Data from two Phase III trials of benralizumab in severe asthma

• The ZONDA trial evaluating oral corticosteroid (OCS) dosage-sparing effects of benralizumab for patients with severe asthma receiving high-dosage inhaled corticosteroid/long-acting beta-2 agonist bronchodilator (ICS/LABA) and OCS (Abstract A4678).
• The GREGALE study assessing patient- and caregiver-reported functionality, performance, and reliability of an accessorised pre-filled syringe (APFS) used to administer benralizumab subcutaneously in an at-home setting (Abstract A3194).

Advancing treatment options in COPD

• Evaluation of whether intensified treatment with Symbicort (budesonide/formoterol fumarate dihydrate), an ICS/LABA, at the onset of upper respiratory tract infection (URTI) could reduce exacerbations in COPD (Abstract A7708).
• Data showing that Bevespi Aerosphere (glycopyrrolate 9 mcg/formoterol fumarate 4.8 mcg) inhalation aerosol, a fixed-dose dual bronchodilator delivered in a pressurised metered-dose inhaler (pMDI) and utilising innovative Co-Suspension™ Delivery Technology, reduces the risk of first or sustained clinically-important deteriorations versus placebo and monocomponent metered-dose inhalers in COPD patients (Abstract A3594).
• Evaluation of the effects of Daxas (roflumilast), an oral PDE4 inhibitor, on exacerbations in patients with severe COPD and a history of hospitalisation receiving inhaled combination therapy (REACT/RE2SPOND) (Abstract A5724).

Evolving scientific understanding of disease modification

• Data highlighting breakthrough science aimed at potentially modifying underlying biological drivers of respiratory diseases, with a research focus on three areas:

o   Lung epithelium including new data on tezepelumab in adolescents (Abstract A5103) and further evidence of ENaC inhibition with AZD5634 in cystic fibrosis (Abstracts A6466, A7306).

o   Lung immunity including data on the role of dendritic cells in priming cytotoxic natural killer cells in COPD (Abstract A7354), new evidence of the modulation of CysLt and lipoxin production in human nasal polyps by LTC4S inhibition (Abstract A3169), and data improving the understanding of the host immune defence to viral infections driving exacerbations in asthma (Abstract A3178).

o   Lung regeneration including an abstract on the role of transglutaminase-2 in lung fibrosis (Abstract A2383) and new evidence of the role of extracellular matrix as a disease driver in COPD lung (Abstract A6296).

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 2016. 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 both pMDIs and dry powder inhalers, as well as the innovative Co-Suspension^TM Delivery Technology. The Company’s biologics include benralizumab (anti-eosinophil, anti-IL-5rɑ), which has been accepted for regulatory review in the US, EU and Japan, tralokinumab (anti-IL-13), which is currently in Phase III, and tezepelumab (anti-TSLP), which successfully achieved its Phase IIb primary endpoint. 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 in Gaithersburg, Md., one of AstraZeneca’s three global R&D centres, with additional sites in Cambridge, UK and Mountain View, CA. 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 main therapy areas - Oncology, Cardiovascular & Metabolic Diseases 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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