Statistically significant and clinically meaningful BATURA Phase III trial results provide new evidence for AIRSUPRA as standard of care for as-needed rescue treatment in asthma

WILMINGTON, Del.--(BUSINESS WIRE)--Positive full results from the BATURA Phase IIIb trial showed AstraZeneca’s anti-inflammatory reliever rescue therapy, AIRSUPRA (albuterol/budesonide), demonstrated statistically significant and clinically meaningful improvements in all primary and secondary endpoints compared to albuterol in patients with mild asthma.1,2 These data were published in the New England Journal of Medicine and presented today at the American Thoracic Society (ATS) 2025 International Conference in San Francisco, CA.1 The trial measured as-needed AIRSUPRA compared to as-needed albuterol, the most commonly used rescue medicine in the US.3 The BATURA trial demonstrated treatment with AIRSUPRA significantly reduced the risk of a severe exacerbation by 47% (5.1% , 9.1%, hazard ratio [HR] 0.53; 95% confidence interval [CI], 0.39, 0.73; p<0.001) when compared with albuterol alone. The overwhelming efficacy of AIRSUPRA at a pre-specified interim analysis led to the early stop of the BATURA trial as recommended by the Independent Data Monitoring Committee.4 BATURA builds upon the previous Phase III MANDALA and DENALI trials and in totality, the clinical program demonstrates the benefit of as-needed AIRSUPRA in reducing the risk of severe exacerbations across all asthma severities compared to albuterol alone.3,5 This BATURA data also aligns to the latest global recommendations from the Global Initiative for Asthma which recommends an anti-inflammatory reliever combination therapy taken as-needed as the preferred reliever therapy in mild asthma.6 Mild asthma, affecting 50% to 70% of patients, is often assumed to be low-risk, yet can result in severe or even fatal exacerbations.7,8 People with mild asthma or infrequent asthma symptoms represent up to 30% of all reported asthma-related exacerbations and deaths.7,8 Craig LaForce, MD, Medical Director of North Carolina Clinical Research, said: “The unprecedented BATURA trial results provide an opportunity to change 50 years of clinical practice in asthma. For decades, millions of patients have relied on albuterol-only rescue treatment in asthma, leaving them unprotected against the increasing airway inflammation that could lead to a more serious attack. The results from the AIRSUPRA BATURA trial add to a wide body of evidence on the value of the anti-inflammatory reliever rescue approach to not only provide immediate relief from symptoms, but also reduce inflammation to prevent future and more severe exacerbations for patients living with asthma across all severities.” Tonya Winders, President of Global Allergy and Airways Patient Platform (GAAPP), said: “Patients who live with asthma are often at risk for unexpected exacerbations. Using an anti-inflammatory reliever therapy can transform every use of a rescue inhaler into an opportunity for early intervention to address the underlying inflammation of asthma, helping to prevent attacks and reduce exposure to systemic steroids. This is especially important for patients with mild asthma whose risk for severe exacerbations is often underestimated." Sharon Barr, Executive Vice-President and Head of BioPharmaceuticals R&D, AstraZeneca, said: “The exciting results from the BATURA trial, coupled with the findings from MANDALA and DENALI, clearly demonstrate the superiority of AIRSUPRA over albuterol alone across all asthma severities. We hope these comprehensive results accelerate the use of anti-inflammatory rescue therapy as the preferred standard of care, in line with recommendations from the Global Initiative for Asthma.” In a key secondary endpoint, adults and adolescents ages 12 and older receiving AIRSUPRA had 63% lower exposure to total systemic corticosteroids (SCS) (p<0.001) over the treatment period compared with albuterol-alone, thereby reducing known risks from cumulative exposure to SCS. Similar reductions in all primary and secondary endpoints were seen in a prespecified subgroup of adult patients (≥18 years) on treatment. SCS are commonly used to control inflammation in asthma, treatment of exacerbations, however as few as 1-3 short courses of SCS are associated with an increased risk of adverse health conditions including type 2 diabetes, depression/anxiety, renal impairment, cataracts, cardiovascular disease, pneumonia and fracture.9 Safety findings in the BATURA trial demonstrated the safety and tolerability of AIRSUPRA was consistent with its well-established safety profile. There were no clinically meaningful differences in safety results between the AIRSUPRA and albuterol groups. AIRSUPRA is the first and only anti-inflammatory rescue medication approved in 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. The US approval was based on results from the MANDALA and DENALI Phase III trials.3,5 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.10,11 AIRSUPRA was developed by AstraZeneca and Avillion. Outside of the US, AIRSUPRA is approved in the United Arab Emirates, Kuwait, Bahrain, Qatar and Oman. Summary of Results: BATURA Notes Asthma Asthma is a chronic, inflammatory respiratory disease with variable symptoms that affects as many as 262 million people worldwide,3 including over 25 million in the US.12 Patients with asthma experience recurrent breathlessness and wheezing, which varies over time, and in severity and frequency.6 These patients are at risk of severe exacerbations regardless of their disease severity, adherence to treatment or level of control.13,14 There are an estimated 136 million asthma exacerbations globally per year,15 including more than 10 million in the US;12 these are physically threatening and emotionally significant for many patients16 and can be fatal.12,17 Inflammation is central to both asthma symptoms13 and exacerbations.18 Many patients experiencing asthma symptoms use a SABA (e.g. albuterol) as a rescue medicine;19-21 however, taking a SABA alone does not address inflammation, leaving patients at risk of severe exacerbations,22 which can result in impaired quality of life,23 hospitalization24 and frequent oral corticosteroid (OCS) use.25 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.9 International recommendations from the Global Initiative for Asthma no longer recommend SABA alone as the preferred rescue therapy.8 Phase IIIb BATURA trial BATURA was a Phase IIIb, US, randomized, 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 albuterol, or as-needed SABA on a background of either low-dose inhaled corticosteroids (ICS) or leukotriene receptor antagonists (LTRA) maintenance therapy.25 Participants (n=2421) were randomized and treated 1:1 with AIRSUPRA (n=1209) or albuterol as needed (n=1212) for 12-52 weeks. Two efficacy analysis populations were defined: the on-treatment population (data collected on-treatment before randomized treatment discontinuation or step-up maintenance therapy) and the intent-to-treat (ITT) population (all data, regardless of these events).1 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. A severe exacerbation was defined as a worsening of symptoms resulting in three or more days of SCS use, an emergency department, urgent care visit or hospitalization for asthma or death.1 BATURA was a first-ever decentralized, patient-centric design allowed participants to accommodate trial-related activities around their daily lives and was intended to remove logistical barriers, thereby lowering participant burden and increasing efficiency and equitable access to the study.1 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 pressurized metered-dose inhaler (pMDI) using AstraZeneca’s Aerosphere delivery technology. AstraZeneca’s Collaboration with Avillion In March 2018, AstraZeneca and Avillion signed an agreement to advance AIRSUPRA through a global clinical development program 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 program for AIRSUPRA through NDA filing to a regulatory decision in the US. Following the successful approval of AIRSUPRA, AstraZeneca is commercializing 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 is a global, science-led biopharmaceutical company that focuses on the discovery, development and commercialization 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 www.astrazeneca-us.com and follow the Company on social media @AstraZeneca. References LaForce, C, et al. As-needed Albuterol–Budesonide in Mild Asthma. Engl J Med. 2025; Available at: https://www.nejm.org/doi/full/10.1056/NEJMoa2504544. Bonini M, et al. Minimal clinically important difference for asthma endpoints: an expert consensus report. Eur Respir Rev. 2020; 29: 190137. 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. AstraZeneca news release. Airsupra demonstrated statistically significant and clinically meaningful reduction in the risk of severe exacerbations in patients with intermittent or mild persistent asthma in BATURA Phase III trial. Available at: https://www.astrazeneca.com/media-centre/press-releases/2024/airsupra-positive-results-phase-iii-batura-trial.html. [Last accessed: May 2025]. Papi A, et al. Albuterol–Budesonide Fixed-Dose Combination Rescue Inhaler for Asthma. N Engl J Med. 2022; 386 (22): 2071-2083. 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. [Last accessed: May 2025]. Lugogo n, et al. Exacerbation burden in patients treated as intermittent or mild-persistent asthma using short-acting β2-agonist rescue. Annals of Allergy, Asthma & Immunology, Volume 134, Issue 5, 2025, Pages 539-547.e1, ISSN 1081-1206, https://doi.org/10.1016/j.anai.2025.02.009. [Last accessed: May 2025]. Cicco M, et al. Intermittent and mild persistent asthma: how therapy has changed. Acta Biomed. 2021 Nov 29;92(S7):e2021523. doi: 10.23750/abm.v92iS7.12422. PMID: 34842585; PMCID: PMC9431889. [Last accessed: May 2025]. Price DB, et al. Adverse outcomes from initiation of systemic corticosteroids for asthma: long-term observational study. J Asthma Allergy. 2018; 11: 193–204. 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. [Last accessed: May 2025]. 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. [Last accessed: May 2025]. CDC. Most Recent National Asthma Data. [Online]. Available at: https://www.cdc.gov/asthma/most_recent_national_asthma_data.htm. [Last accessed: May 2025]. 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. 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. AstraZeneca Pharmaceuticals. Data on File. 2024. Budesonide/formoterol Data on File: Annual Rate of Asthma Exacerbations Globally. (REF-173201). 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. Fernandes AG, et al. Risk factors for death in patients with severe asthma. J Bras Pneumol. 2014; 40 (4): 364-372. Wark PA, et al. Asthma exacerbations 3: pathogenesis. Thorax. 2006; 61 (10): 909-15. Johnson DB, Merrell BJ, Bounds C. (2022). Albuterol. StatPearls [Internet]. Treasure Island, Florida: StatPearls Publishing. Montemayor T, et al. Albuterol: Often Used and Heavily Abused. Respiratory Care. November 2021; 66 (Suppl 10): 3603775. ClinCalc.com. Albuterol: Drug Usage Statistics, US 2013 – 2020. Available at: https://clincalc.com/DrugStats/Drugs/Albuterol. [Last accessed: May 2025]. 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. 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. 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. Clinicaltrials.gov. A Comparison of PT027 vs PT007 Used as Needed in Participants With Asthma (BATURA). Available at https://clinicaltrials.gov/study/NCT05505734 [Last accessed: May 2025]. Last Updated 5/25

Statistically significant and clinically meaningful BATURA Phase III trial results provide new evidence for AIRSUPRA as standard of care for as-needed rescue treatment in asthma

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