New data on Symbicort as a potential anti-inflammatory reliever in mild asthma to be presented at ATS 2019

A total of 73 abstracts to be presented at ATS 2019 International Conference  from across AstraZeneca’s respiratory portfolio

New data from the Symbicort Turbuhaler (budesonide/formoterol) Novel START trial is among 73 AstraZeneca abstracts accepted for oral or poster presentation at the American Thoracic Society (ATS) 2019 International Conference,17-22 May in Dallas, US.

Novel START, an open-label trial designed to reflect real-world practice, assesses the effectiveness of Symbicort Turbuhaler as a potential anti-inflammatory reliever taken as-needed, compared with two of the most commonly used treatment regimens in mild asthma: as-needed short-acting beta2-agonist (SABA) alone or low-dose inhaled corticosteroid (ICS) maintenance treatment plus as-needed SABA.

AstraZeneca will also present new science supporting its biologics portfolio and pipeline.Presentations include: data from an integrated analysis of Fasenra’s (benralizumab) long-term efficacy and safety profile and ability to reduce oral corticosteroid use in patients with severe eosinophilic asthma; the impact of tezepelumab on hospitalisation and emergency department visits; and the first-in-human data for the Company’s potential inhaled biologic AZD1402, an IL-4Ra antagonist, currently in development for the treatment of asthma.

Tom Keith-Roach, Senior Vice President, Respiratory, said: “We look forward to sharing the results from the Novel START trial which looks at Symbicort used as an anti-inflammatory reliever versus short-acting beta2-agonist, the most commonly used reliever therapy today. In biologics, new long-term efficacy and safety data continues to build Fasenra’s clinical profile, and with more than 70 abstracts overall, AstraZeneca is demonstrating its commitment to advancing respiratory science.”

AstraZeneca’s main abstracts at ATS 2019 include:

Symbicort Turbuhaler (budesonide/formoterol)

Pragmatic randomized controlled trial of budesonide/formoterol reliever therapy in adults with mild asthma (Late-breaker Rapid Abstract Poster Discussion, poster #A7477 / 525, Wednesday 22 May, 13:30-15:30, session D101, room D222-D224)Abstract embargoed at this time

Qualitative research on patient experiences of as-needed budesonide/formoterol for treatment of mild asthma(Rapid Abstract Poster Discussion, poster #A7457 / 1022, Wednesday 22 May, 9:15-11:15, session D22, room Trinity Ballroom 5-7)

Efficacy of as-needed budesonide/formoterol for reducing severe exacerbations in adolescents with mild asthma: pooled subgroup analysis of the SYGMA 1 and 2 trials (Rapid Abstract Poster Discussion, poster # A7191 / 816, Wednesday 22 May, 13:30-15:30, session D105, room Dallas Ballroom E-F)

Influence of prior treatment upon the efficacy of as-needed budesonide/formoterol in mild asthma in the SYGMA 1 and 2 Studies (Rapid Abstract Poster Discussion, poster #A7082 / 504, Wednesday 22 May, 13:30-15:30, session D101, room D222-D224)

Patient decision-making around use of reliever inhalers in mild asthma (Rapid Abstract Poster Discussion, poster #A5935 / 1017, Wednesday 22 May, 9:15-11:15, session D22, room Trinity Ballroom 5-7)

In the US, Symbicort is approved for use in a pressurised metered-dose inhaler device, but not the Turbuhaler device.

Fasenra

Oral Corticosteroid Tapering During benralizumab Treatment of Severe, Uncontrolled Eosinophilic Asthma: PONENTE Phase IIIb Clinical Trial (Thematic Poster Discussion, poster #A1320 / P711, Sunday 19 May, 11:15-13:00, session A32, room Area E)

Two-Year Integrated Efficacy and Safety Analysis of benralizumab SIROCCO, CALIMA, ZONDA, and BORA Trials in Severe Asthma (Rapid Abstract Poster Discussion, poster #A2676 / 511, Monday 20 May, 9:15-11:15, session B21, room D222-D224)

PT010

Seasonal Variation in COPD Exacerbations: a Post-Hoc Analysis from the KRONOS Phase III Study of Budesonide/Glycopyrrolate/Formoterol Fumarate Metered Dose Inhaler (BGF MDI) (Thematic Poster, poster #A1571 / P135, Sunday 19 May, 11:15-13:00, session A41, room Area B)

Bevespi

Benefits of Glycopyrrolate/Formoterol Fumarate Metered Dose Inhaler (GFF MDI) in Reducing Exacerbation Risk in Patients with Moderate-to-Very Severe COPD: A Pooled Analysis of the PINNACLE Studies (Thematic Poster, poster #A1588 / P152, Sunday 19 May, 11:15-13:00, session A41, room Area B)

Benefits of Glycopyrrolate/Formoterol Fumarate Metered Dose Inhaler (GFF MDI) in Symptomatic Patients with COPD: A Post-Hoc Analysis from a Phase III, Randomized, Placebo-Controlled Study (PINNACLE-4) (Thematic Poster, poster #A3342 / P531, Monday 20 May, 11:15-13:00, session B45, room Area D)

Aclidinium franchise

Aclidinium bromide added to a long-acting β2-agonist +/- inhaled corticosteroid: effects on exacerbations, lung function and symptoms in patients with chronic obstructive pulmonary disease and cardiovascular risk factors (ASCENT-COPD) (Rapid Abstract Poster Discussion, poster #A2451 / 217, Sunday 19 May, 14:15-16:15, session A102, room C141/C143/C149)

Aclidinium bromide treatment in patients receiving beta-blockers: Effects on MACE, moderate/severe COPD exacerbations, and lung function in patients with moderate-to-very severe COPD and cardiovascular risk factors (ASCENT-COPD) (Rapid Abstract Poster Discussion, poster #A2443 / 209, Sunday 19 May, 14:15-16:15, session A102, room C141/C143/C149)

Potential new medicines and breakthrough research

The impact of tezepelumab on hospitalization and emergency department visits in patients with severe uncontrolled asthma: results from the PATHWAY Phase IIb trial (Oral Presentation A2622 Mini Symposium, session B15 Immunotherapy for lung disease, Monday 20 May, 9:30-9:45, room C146)

Tezepelumab treatment effect on annualized rate of exacerbations by baseline biomarkers in uncontrolled severe asthma patients: Phase IIb PATHWAY study (Oral Presentation A2621 Mini Symposium, session B15 Immunotherapy for lung disease, Monday 20 May, 9:15-9:30, room C146)

First-in-human data for the inhaled IL-4Ra antagonist, AZD1402/PRS-060, reveals a promising clinical profile for the treatment of asthma(Late-breaker Thematic Poster, poster #A7476 / 524, Wednesday 22 May, 13:30-15:30, session D101, room D222-D224)

Characterisation of Patients with Obstructive Lung Disease in the NOVEL Observational LongiTudinal StudY, NOVELTY (Late-breaker Thematic Poster, poster #A7394 / P554, Tuesday 21 May, 11:15-13:00, session C37, room Area D)

New data on the International Severe Asthma Registry (ISAR): The story so far and Cross-Country Comparison of Demographic and Clinical Characteristics of Patients Managed in Severe Asthma Services across UK, USA, Australia, South Korea, and Italy(Thematic Posters, poster #A4899 / P590, Tuesday 21 May, 11:15-13:00, session C44, room Area D). ISAR is conducted by Optimum Patient Care Global Limited, and co-funded by OPC Global and AstraZeneca.

About AstraZeneca in respiratory disease

Respiratory is one of AstraZeneca’s main therapy areas, and our medicines reached more than 18 million patients as maintenance therapy in 2018. 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 in development for severe nasal polyposis and other potential indications, and tezepelumab (anti-TSLP), which has been granted Breakthrough Therapy Designation by the US Food and Drug Administration in patients with severe asthma and is in Phase III trials. AstraZeneca’s research aims at addressing underlying disease drivers by focusing on the lung epithelium, lung immunity, lung regeneration and neuronal functions.

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. AstraZeneca operates in over 100 countries and its innovative medicines are used by millions of patients worldwide. For more information, please visit astrazeneca.comand follow us on Twitter @AstraZeneca.