AstraZeneca to present data on next generation of biologics at European Respiratory Society International Congress 2017

Presentation of the PATHWAY Phase IIb data for tezepelumab, a first-in-class treatment that blocks thymic stromal lymphopoietin (TSLP), in patients with severe, uncontrolled asthma

New analysis of benralizumab Phase III trials, SIROCCO and CALIMA, which reinforces the potential new medicine’s efficacy and identifies key predictors of an enhanced treatment effect

4 September 2017

AstraZeneca and its global biologics research and development arm, MedImmune, will present new data on its respiratory portfolio and pipeline at the European Respiratory Society (ERS) International Congress, 9-13 September 2017 in Milan, Italy. The breadth and depth of science are reflected in the 48 accepted abstracts, including 11 oral presentations, which will focus on areas of unmet treatment needs in asthma and chronic obstructive pulmonary disease (COPD).

Highlights will cover rapidly-advancing research on the next generation of biologics that target the underlying drivers of respiratory disease. In particular, the full tezepelumab PATHWAY Phase IIb data in patients with severe, uncontrolled asthma will be presented as a late-breaking abstract at ERS. Tezepelumab is a first-in-class biologic targeting thymic stromal lymphopoietin (TSLP), an upstream ‘master-switch’ that drives multiple inflammatory pathways in asthma. Additionally, a new analysis of the benralizumab SIROCCO and CALIMA Phase III trials in severe, uncontrolled asthma will reinforce the potential new medicine’s efficacy and will identify those patients who may have an enhanced response to the new medicine.

Tom Keith-Roach, Vice President, Respiratory at AstraZeneca, said: “The tezepelumab and benralizumab data at the ERS Congress represent the next generation of respiratory biologics that have the potential to truly transform asthma care by targeting the underlying causes of the disease. Respiratory is one of AstraZeneca’s three main therapy areas and we are excited to demonstrate the strength of our science and the breadth of our rapidly-expanding portfolio with 48 abstracts covering emerging science and new inhaled treatment paradigms.”

Advancing biologics in severe, uncontrolled asthma

• Results from the tezepelumab PATHWAY Phase IIb study which evaluates the impact of tezepelumab on exacerbations in patients with severe, uncontrolled asthma (Late-breaking abstract OA3189 with oral presentation).

Growing body of data to support benralizumab – a potential new medicine

• Post-hoc analysis of the benralizumab SIROCCO and CALIMA Phase III trials which identifies key factors that predict an enhanced response to benralizumab for severe, uncontrolled asthma (Late-breaking abstract OA2902 with oral presentation).
• Benralizumab attenuates airway eosinophilopoietic processes in prednisone-dependent asthma (Abstract OA3217 with oral presentation).
• Asthma patients with high blood eosinophil counts have a greater risk of rehospitalisation for exacerbations (Abstract OA3214 with oral presentation).

New evidence on the protective benefit of Symbicort (budesonide/formoterol) in COPD patients at risk of exacerbation

• Results from INCONTROL 1, a first-of-its-kind post-hoc analysis of a large pooled data set of Phase III COPD studies, investigate patient characteristics that may interact with the treatment response to budesonide/formoterol versus formoterol alone. The analysis also examines the relationship between blood eosinophil levels, risk of exacerbation and treatment selection in COPD (Abstract PA394 with poster discussion).

Breakthrough science in disease modification

Data highlighting our evolving scientific understanding of disease modification and personalised medicine, including:

• New data on the role of rhinovirus infection as a cause of the dysfunctional anti-bacterial mechanisms contributing to exacerbations in COPD (Abstract OA286 with oral presentation).
• Novel approaches for the segmentation of asthma patients based on biological disease drivers such as activation of eosinophils, Th17 and PI3Kgd (Abstracts PA1131, PA569 with poster discussion, late-breaking abstract OA2933 with oral presentation, and PA4920 with poster discussion).

Breakthrough science in drug delivery technology

• New data evaluates how Functional Respiratory Imaging (FRI) helps characterise the physiological effect of PT003 (glycopyrrolate/formoterol fumarate MDI) formulated using the novel Aerosphere^TM Delivery Technology, supporting lung function endpoint improvements in COPD. (Late breaking abstract OA4404 with podium presentation)

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 key therapeutic areas, including respiratory, inflammation and autoimmunity; cardiovascular and metabolic disease; oncology; neuroscience; and infection and vaccines. The MedImmune headquarters is located 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 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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