AstraZeneca to present next wave of science in respiratory disease at ERS International Congress

65 abstracts to be presented from AstraZeneca’s respiratory portfolio and pipeline including Symbicort in mild to moderate asthma, and Breztri and Fasenra in COPD

AstraZeneca will present new data on its portfolio of inhaled combination and biologic therapies, and pipeline of emerging medicines at the European Respiratory Society (ERS) International Congress, which takes place from 28 September to 2 October in Madrid, Spain. The breadth and depth of science is reflected in the 65 abstracts accepted, including 17 oral presentations.

In inhaled combinations, a new analysis from the Phase III KRONOS trial will be presented assessing the benefit of triple-combination therapy Breztri Aerosphere (budesonide/glycopyrronium/formoterol fumarate) on exacerbation rates over time in patients with moderate to very severe chronic obstructive pulmonary disease (COPD).

In addition, data will be presented from PRACTICAL1, an independent trial investigating Symbicort Turbuhaler (budesonide/formoterol) used as an anti-inflammatory reliever in mild to moderate asthma.  Following Novel START2, PRACTICAL is the second trial designed to reflect real-world practice comparing Symbicort Turbuhaler used as an anti-inflammatory reliever therapy to current standard of care in mild to moderate asthma.

In biologics, highlights will include a new analysis of the Phase III GALATHEA and TERRANOVA trials for Fasenra (benralizumab), a potential treatment in COPD, which identifies the clinical characteristics of COPD patients who may benefit from Fasenra.   

Tom Keith-Roach, Senior Vice President, Respiratory, said: “The PRACTICAL and KRONOS data show that Symbicort Turbuhaler anti-inflammatory reliever therapy and Breztri Aerosphere have the potential to transform care and improve outcomes for patients. With 65 abstracts and 17 oral presentations, the breadth and depth of data at the ERS International Congress reflect AstraZeneca’s commitment to respiratory medicine and represent the next wave of science in respiratory disease.”

AstraZeneca key abstracts at the ERS International Congress include:

Symbicort Turbuhaler

·       Impact of COPD symptom-related attacks on quality of life and exacerbations (Late-breaker Oral Presentation, #OA258, Sunday 29 September, 08:30-10:30, session 53/room 6F)

·       SABA overuse and risk of mortality in a nationwide Swedish asthma cohort (HERA) (Late-breaker Oral Presentation, #OA2105, Monday 30 September, 10:45-12:45, session 250/room 8A)

·       Use of short-acting beta2 agonists (SABA) and exacerbations in a nationwide Swedish asthma cohort (HERA) (Thematic Poster, #PA2554, Monday 30 September, 12:50-14:40, session 281/room TP-16)

·       SABA and ICS use among mild asthma patients in UK primary care (Thematic Poster, #PA2565, Monday 30 September, 12:50-14:40, session 281/room TP-16)

·       Cost effectiveness of as-needed budesonide/formoterol vs low-dose ICS maintenance therapy in mild asthma patients: A UK perspective (Late-breaker Poster Discussion, #PA1964, Monday 30 September, 08:30-10:30, session 230/room 6B)

·       Open-label trial of budesonide/formoterol reliever therapy in mild asthma (Late-breaker Oral Presentation, #OA5332, Wednesday 2 October, 10:45-12:45, session 552/room 6F)

Breztri Aerosphere

·       Effect of COPD exacerbations on early lung function decline under maintenance therapy: blood eosinophil count as biomarker (Oral Presentation, #OA 2154, Monday 30 September, 10:45-12:45, session 256/room N101 + 102)

·       Analysis of exacerbation rates by time interval post-randomization in the KRONOS Phase III study of budesonide/glycopyrronium/formoterol fumarate dihydrate metered dose inhaler (BGF MDI) (Thematic Poster, #PA2481, Monday 30 September, 12:50-14:40, session 277/room TP-12)

·       Pneumonia risk with budesonide-containing therapies in COPD: pooled analysis of three Phase III studies (Poster Discussion, #PA3375, Monday 30 September, 14:45-16:45, session 356/room 6D)

Fasenra

·       Identification of patients with COPD who benefit from benralizumab (Late-breaker Clinical Trials Session, #RCT446, Sunday 29 September, 10:45-12:45, session 76/room 9C)

·       Baseline predictors of being exacerbation-free during 2 years of benralizumab treatment (Oral Presentation, #OA5337, Wednesday 2 October, 10:45-12:45, session 552/room 6F)

Potential new medicines and breakthrough research

·       Multiple ascending dose study of the inhaled IL-4Ra antagonist, AZD1402/PRS-060, in mild asthmatics demonstrates robust FeNO reduction and a promising clinical profile for the treatment of asthma (Late-breaker Poster Discussion, #PA3709, Tuesday 1 October, 08:30-10:30, session 400, room RETIRO)

·       Phase 1 evaluation of the inhaled IL-4Ra antagonist, AZD1402/PRS-060, a potent and selective blocker of IL-4Ra (Oral Presentation, #OA5336, Wednesday 2 October, 10:45-12:45, session 552/room 6F)

·       First clinical results from AZD8154 (a selective PI3Kγδ inhibitor); Safety, tolerability and pharmacokinetics of AZD8154 after single ascending inhaled doses in healthy volunteers (Thematic Poster, #PA4220, Tuesday 1 October, 12:50-14:40, session 445/room TP-15)

Real world evidence

·       Characteristics by physician-assigned severity of asthma, asthma + COPD and COPD patients in the NOVELTY study (Poster Discussion, #PA5029, Tuesday 1 October, 14:45-16:45, session 551/room 6D)

·       Epidemiology of lung function in a global severe asthma population (Poster Discussion, PA5023, Tuesday 1 October, 14:45-16:45, session 511/room 6D).  ISAR is conducted by Optimum Patient Care Global Limited, and co-funded by OPC Global and AstraZeneca

About AstraZeneca in respiratory diseases

Respiratory is one of AstraZeneca’s three 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-IL5 receptor alpha), 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 and Metabolism (CVRM), and Respiratory. AstraZeneca operates in over 100 countries and its innovative medicines are used by millions of patients worldwide. Please visit astrazeneca.com and follow us on Twitter @AstraZeneca.

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References

1. Hardy J, Baggott C, Fingleton J, et al. Open-label trial of budesonide/formoterol reliever therapy in mild asthma. Lancet. 2019; published online August 23, 2019 http://dx.doi.org/10.1016/S0140-6736(19)31948-8

2. Beasley RW, Holliday M, Reddel HK, et al. Controlled trial of budesonide-formoterol as needed for mild asthma. N Engl J Med. 2019; Epub ahead of print (DOI: 10.1056/NEJMoa1901963)