Airsupra demonstrated statistically significant and clinically meaningful reduction in risk of severe exacerbations in patients with intermittent or mild persistent asthma in BATURA Phase III trial

Independent Data Monitoring Committee recommended trial stop early due to overwhelming efficacy at pre-planned analysis. AstraZeneca’s inhaled anti-inflammatory rescue medication Airsupra demonstrated significant benefit compared to albuterol.

Positive high-level results from the BATURA Phase IIIb trial showed AstraZeneca’s Airsupra (albuterol/budesonide) met the primary endpoint, demonstrating a statistically significant and clinically meaningful reduction in the risk of a severe exacerbation when used as an as-needed rescue medication in response to symptoms compared to as-needed albuterol.¹ The trial included patients with intermittent or mild persistent asthma, including those on short-acting beta2-agonist (SABA) alone, low-dose inhaled corticosteroid (ICS) maintenance therapy, or leukotriene receptor antagonist (LTRA) maintenance therapy.

Asthma is a chronic, inflammatory respiratory disease with variable symptoms that affects as many as 262 million people worldwide,² including over 25 million in the US.³ Patients with mild asthma comprise at least 50% of the US asthma population and are at risk of severe exacerbations.^4,5

James Donohue, Emeritus Professor of Pulmonary Medicine, University of North Carolina, and Chair, Independent Data Monitoring Committee, said: “People with asthma are at risk of severe exacerbations regardless of their disease severity or level of control. By focusing on patients with intermittent or mild persistent asthma, the strong BATURA trial results further demonstrate the clinically meaningful benefit of an anti-inflammatory rescue approach to reduce the risk of severe exacerbations by treating both symptoms and inflammation at the same time.”

Sharon Barr, Executive Vice-President, BioPharmaceuticals R&D, AstraZeneca, said: “The impressive BATURA trial results add to the body of evidence supporting Airsupra as a first-in-class rescue treatment and its role in reducing the risk of asthma exacerbations in patients regardless of their disease severity, and reducing the need for systemic corticosteroids.”

The safety and tolerability of Airsupra in the BATURA trial was consistent with its established profile and no new safety concerns were reported. The data will be shared with health authorities and will be presented as a late-breaker oral presentation at the American College of Allergy, Asthma & Immunology (ACAAI) Annual Scientific Meeting on 26 October 2024.

Airsupra is the first and only anti-inflammatory rescue medication approved in the US for the as-needed treatment or prevention of bronchoconstriction and to reduce the risk of exacerbations in people with asthma aged 18 years and older.⁶ The US approval was based on results from the MANDALA and DENALI Phase III trials.^7,8 Airsupra is also being studied in adolescents with asthma (12 to <18 years old) in the ACADIA Phase III trial and in patients in China in the BAIYUN Phase III trial.^9,10 Airsupra is being developed by AstraZeneca and Avillion.

Notes

Asthma
Asthma is a chronic, inflammatory respiratory disease with variable symptoms that affects as many as 262 million people worldwide,² including over 25 million in the US.³

Patients with asthma experience recurrent breathlessness and wheezing, which varies over time, and in severity and frequency.¹¹ These patients are at risk of severe exacerbations regardless of their disease severity, adherence to treatment or level of control.^12,13 There are an estimated 136 million asthma exacerbations globally per year,¹⁴  including more than 10 million in the US;³ these are physically threatening and emotionally significant for many patients¹⁵ and can be fatal.^2,16

Inflammation is central to both asthma symptoms¹² and exacerbations.¹⁷  Many patients experiencing asthma symptoms use a SABA (e.g. albuterol) as a rescue medicine;^18-20 however, taking a SABA alone does not address inflammation, leaving patients at risk of severe exacerbations,²¹ which can result in impaired quality of life,²² hospitalisation²³ and frequent oral corticosteroid (OCS) use.²³ Treatment of exacerbations with as few as 1-3 short courses of OCS are associated with an increased risk of adverse health conditions including type 2 diabetes, depression/anxiety, renal impairment, cataracts, cardiovascular disease, pneumonia and fracture.²⁴ International recommendations from the Global Initiative for Asthma no longer recommend SABA alone as the preferred rescue therapy.¹¹

BATURA 
BATURA is a Phase IIIb, US, randomised, double-blind, parallel-group, event-driven trial, comparing the efficacy and safety of using inhaled albuterol/budesonide (180mcg/160mcg) as an as-needed rescue medication in response to symptoms compared to as-needed albuterol (180mcg) for up to 12 months. Patients recruited were aged 12 years and over with intermittent or mild persistent asthma and must have been using as-needed SABA alone, or as-needed SABA on a background of either low-dose ICS or LTRA maintenance therapy.²⁵

The primary efficacy endpoint was the time to first severe asthma exacerbation during the study period. Secondary endpoints included severe exacerbation rate and total systemic corticosteroid use.²⁵

Airsupra
Airsupra (albuterol/budesonide), formerly known as PT027, is a first-in-class SABA/ICS rescue treatment for asthma in the US, to be taken as needed. It is an inhaled, fixed-dose combination rescue medication containing albuterol (also known as salbutamol), a SABA, and budesonide, a corticosteroid, and has been developed in a pressurised metered-dose inhaler (pMDI) using AstraZeneca’s Aerosphere delivery technology.⁶

Outside of the US, Airsupra is also approved in the United Arab Emirates, Kuwait, Bahrain, Qatar and Oman.

AstraZeneca’s Collaboration with Avillion
In March 2018, AstraZeneca and Avillion signed an agreement to advance Airsupra through a global clinical development programme for the treatment of asthma. Under the terms of the agreement, Avillion became the trial sponsor responsible for executing and funding the global, multicentre clinical trial programme for Airsupra through NDA filing to a regulatory decision in the US. Following the successful approval of Airsupra, AstraZeneca is commercialising the medicine. AstraZeneca extended its agreement with Avillion in 2022 to undertake the BATURA Phase IIIb trial to further assess the role of Airsupra in reducing the risk of asthma exacerbations.

AstraZeneca in Respiratory & Immunology
Respiratory & Immunology, part of AstraZeneca BioPharmaceuticals, is a key disease area and growth driver to the Company.

AstraZeneca is an established leader in respiratory care with a 50-year heritage and a growing portfolio of medicines in immune-mediated diseases. The Company is committed to addressing the vast unmet needs of these chronic, often debilitating, diseases with a pipeline and portfolio of inhaled medicines, biologics and new modalities aimed at previously unreachable biologic targets. Our ambition is to deliver life-changing medicines that help eliminate COPD as a leading cause of death, eliminate asthma attacks and achieve clinical remission in immune-mediated diseases.

AstraZeneca
AstraZeneca (LSE/STO/Nasdaq: AZN) is a global, science-led biopharmaceutical company that focuses on the discovery, development, and commercialisation of prescription medicines in Oncology, Rare Diseases, and BioPharmaceuticals, including Cardiovascular, Renal & Metabolism, and Respiratory & Immunology. Based in Cambridge, UK, AstraZeneca’s innovative medicines are sold in more than 125 countries and used by millions of patients worldwide. Please visit astrazeneca.com and follow the Company on social media @AstraZeneca

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References

1. Bonini M, Di Paolo M, Bagnasco D, et al. Minimal clinically important difference for asthma endpoints: an expert consensus report. Eur Respir Rev. 2020; 29: 190137.
2. Global Asthma Network. The Global Asthma Report 2022. [Online]. Available at: http://globalasthmareport.org/resources/Global_Asthma_Report_2022.pdf. Accessed September 2024. 
3. CDC. Most Recent National Asthma Data. [Online]/ Available at: https://www.cdc.gov/asthma/most_recent_national_asthma_data.htm. Accessed September 2024.
4. Quint JK, et al; SABINA North American and European Study contributors. Short-Acting Beta-2-Agonist Exposure and Severe Asthma Exacerbations: SABINA Findings From Europe and North America. J Allergy Clin Immunol Pract. 2022; 10 (9): 2297-2309.e10.
5. Pollack M, et al. The use of short-acting bronchodilators and cost burden of asthma across Global Initiative for Asthma-based severity levels: Insights from a large US commercial and managed Medicaid population. J Manag Care Spec Pharm 2022; 28(8):881-891.
6. AstraZeneca. [Online]. Airsupra (PT027) approved in the US for asthma. Available at https://www.astrazeneca.com/media-centre/press-releases/2023/airsupra-pt027-approved-in-the-us-for-asthma.html. Accessed September 2024.
7. Papi A, et al. Albuterol–Budesonide Fixed-Dose Combination Rescue Inhaler for Asthma. N Engl J Med 2022; 386 (22): 2071-2083.
8. Chipps BE, et al. Efficacy and safety of albuterol/budesonide (PT027) in mild-to-moderate asthma: Results of the DENALI study. Am J Respir Crit Care Med 2022; 205: A3414. Abstract. Available at: https://doi.org/10.1164/ajrccm-conference.2022.205.1_MeetingAbstracts.A3414 Accessed September 2024.
9. Clinicaltrials.gov. Evaluating the Efficacy and Safety of PT027 Compared With PT007 Administered As Needed in Participants 12 to < 18 Years of Age With Asthma (ACADIA). Available at https://clinicaltrials.gov/study/NCT06307665?term=ACADIA&rank=3. Accessed September 2024.
10. Clinicaltrials.gov. A Study to Investigate Efficacy and Safety of PT027 Compared With PT007 in Symptomatic Chinese Adults With Asthma (BAIYUN). Available at https://clinicaltrials.gov/study/NCT06471257?term=BAIYUN&rank=1. Accessed September 2024.
11. Global Initiative for Asthma. Global strategy for asthma management and prevention, 2022. Available at: https://ginasthma.org/wp-content/uploads/2022/07/GINA-Main-Report-2022-FINAL-22-07-01-WMS.pdf. Accessed September 2024.
12. Price D, et al. Asthma control and management in 8,000 European patients: the REcognise Asthma and LInk to Symptoms and Experience (REALISE) survey. NPJ Prim Care Respir Med. 2014; 24: 14009.
13. Papi A, et al. Relationship of inhaled corticosteroid adherence to asthma exacerbations in patients with moderate-to-severe asthma. J Allergy Clin Immunol Pract. 2018; 6 (6): 1989-98.e3.
14. AstraZeneca Pharmaceuticals. Data on File. Budesonide/formoterol Data on File: Annual Rate of Asthma Exacerbations Globally. (REF-173201)
15. Sastre J, et al. Insights, attitudes, and perceptions about asthma and its treatment: a multinational survey of patients from Europe and Canada. World Allergy Organ J. 2016; 9: 13.
16. Fernandes AG, et al. Risk factors for death in patients with severe asthma. J Bras Pneumol. 2014; 40 (4): 364-372.
17. Wark PA, et al. Asthma exacerbations· 3: pathogenesis. Thorax. 2006; 61 (10): 909-15.
18. Johnson DB, et al. Albuterol. 2022 May 1. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2022 Jan. PMID: 29489143.
19. Montemayor T, et al. Albuterol: Often Used and Heavily Abused. Respiratory Care November 2021, 66 (Suppl 10) 3603775.
20. ClinCalc.com. Albuterol: Drug Usage Statistics, US 2013 – 2020. Available at: https://clincalc.com/DrugStats/Drugs/Albuterol. Accessed September 2024.
21. Nwaru BI, et al. Overuse of short-acting β2-agonists in asthma is associated with increased risk of exacerbation and mortality: a nationwide cohort study of the global SABINA programme. Eur Respir J. 2020; 55 (4): 1901872.
22. Lloyd A, et al. The impact of asthma exacerbations on health-related quality of life in moderate to severe asthma patients in the UK. Prim Care Respir J. 2007; 16 (1): 22-7.
23. Bourdin A, et al. ERS/EAACI statement on severe exacerbations in asthma in adults: facts, priorities and key research questions. Eur Respir J. 2019; 54 (3): 1900900.
24. Price DB, et al. Adverse outcomes from initiation of systemic corticosteroids for asthma: long-term observational study. J Asthma Allergy. 2018; 11: 193–204.
25. Clinicaltrials.gov. A Comparison of PT027 vs PT007 Used as Needed in Participants With Asthma (BATURA). Available at https://clinicaltrials.gov/study/NCT05505734?cond=asthma%20&term=BATURA&rank=1 Accessed September 2024.