Early Success: AstraZeneca’s Airsupra Proves Highly Effective in Reducing Severe Asthma Risks in Phase III Trial

Early Success: AstraZeneca’s Airsupra Proves Highly Effective in Reducing Severe Asthma Risks in Phase III Trial

(IN BRIEF) AstraZeneca’s inhaled rescue medication, Airsupra (albuterol/budesonide), has shown significant efficacy in reducing the risk of severe asthma exacerbations in patients with intermittent or mild persistent asthma, according to high-level results from the BATURA Phase IIIb trial. The trial was stopped early following a recommendation from the Independent Data Monitoring Committee due to overwhelming effectiveness. The results support Airsupra as a first-in-class treatment, offering a dual approach by addressing both symptoms and inflammation, potentially reducing the need for systemic corticosteroids. The safety profile of the drug remained consistent with previous studies, and the data will be presented at the upcoming ACAAI Annual Scientific Meeting.

(PRESS RELEASE) CAMBRIDGE, 7-Oct-2024 — /EuropaWire/ — AstraZeneca’s Airsupra, a pioneering inhaled anti-inflammatory rescue medication, has demonstrated exceptional efficacy in the BATURA Phase IIIb trial, leading to the early termination of the study based on a recommendation from the Independent Data Monitoring Committee. In this trial, Airsupra (albuterol/budesonide) significantly reduced the risk of severe asthma exacerbations in patients with intermittent or mild persistent asthma, a milestone achievement when compared to the standard use of albuterol alone. This important result was observed in patients across different treatment regimens, including those on short-acting beta2-agonists (SABA), low-dose inhaled corticosteroids (ICS), or leukotriene receptor antagonists (LTRA).

Asthma, a chronic and inflammatory disease that impacts 262 million people globally, poses significant risks even for those with mild forms of the condition, making these results particularly impactful. In the United States alone, mild asthma accounts for over half of the 25 million people affected by the disease. The BATURA trial underscores the value of an anti-inflammatory rescue approach that treats both symptoms and underlying inflammation, offering a powerful new option for asthma management.

Professor James Donohue, Chair of the Independent Data Monitoring Committee, remarked that these findings are a crucial advancement in asthma care. “Regardless of disease severity, all asthma patients face the risk of severe exacerbations. The results from the BATURA trial affirm the clinical benefit of this anti-inflammatory rescue treatment for reducing those risks in patients with intermittent or mild persistent asthma.”

Sharon Barr, Executive Vice-President of BioPharmaceuticals R&D at AstraZeneca, noted, “The results from the BATURA trial further validate Airsupra as a first-in-class rescue treatment, offering a significant reduction in exacerbation risk without the need for systemic corticosteroids.”

The safety and tolerability profile of Airsupra was consistent with previous studies, and no new safety concerns arose. The findings from the BATURA trial will be shared with health authorities and presented at the upcoming ACAAI Annual Scientific Meeting in October 2024.

Airsupra remains the only US-approved anti-inflammatory rescue medication designed for as-needed use to prevent bronchoconstriction and lower the risk of exacerbations in asthma patients aged 18 and older. It is also being evaluated in adolescents as part of the ACADIA trial, and further studies are ongoing in China. AstraZeneca is developing Airsupra in partnership with 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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