Avillion announces positive high-level results from Phase III BATURA trial with AstraZeneca’s ...

• Independent Data Monitoring Committee recommended trial stop early due to overwhelming efficacy at pre-planned analysis
• Phase IIIb clinical development of Airsupra was conducted by Avillion under an exclusive clinical co-development agreement with AstraZeneca
• Airsupra (albuterol/budesonide) demonstrated statistically significant and clinically meaningful reduction in risk of severe asthma exacerbations in patients with intermittent or mild persistent asthma compared to albuterol alone
  
  

London, UK, 7 October 2024 – Avillion Life Sciences Ltd (“Avillion”) announces that the ongoing BATURA Phase IIIb trial evaluating AstraZeneca’s Airsupra (albuterol/budesonide) in patients with intermittent or mild persistent asthma has delivered positive results. The trial met the primary endpoint, demonstrating a statistically significant and clinically meaningful reduction1 in the risk of a severe exacerbation when used as an as-needed rescue medication in response to symptoms compared to as-needed albuterol.

The trial, which was conducted by Avillion under an exclusive clinical co-development agreement with AstraZeneca, 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.”

Allison Jeynes, MD, Chief Executive Officer of Avillion, said: “We are thrilled with this positive outcome from the BATURA trial, which has generated truly outstanding clinical results. It is extremely gratifying to see that the hard work and dedication put into our long-term collaboration with AstraZeneca around Airsupra has proved so successful over such an extensive global clinical development programme. Our work together in bringing this new therapy to asthma patients really highlights the strong value proposition of our clinical co-development model as well as the clinical and operational excellence that our highly committed international team brings.”

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 trials7,8, which were also conducted successfully by Avillion under its clinical co-development agreement with AstraZeneca.

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

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 full press announcement from AstraZeneca can be found by clicking here.

Notes

About the Avillion and AstraZeneca collaboration
In March 2018, Avillion and AstraZeneca 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.

The Airsupra clinical co-development programme was funded by Blackstone Life Sciences, Royalty Pharma and Abingworth.

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.

About Avillion
Avillion offers pharma partners an innovative model providing clinical development expertise and funding to maximise the potential of new and existing assets. With a 100% track record, Avillion prides itself on adding value around operational expertise as we continue working on exciting clinical development projects across multiple therapy areas, focusing on accelerated clinical development delivering quality data that allow patients to access new treatments. We aim to partner on projects across all stages of clinical development where we can apply our extensive experience and knowledge to improve the chance of positive outcomes.  

Avillion was founded in 2012 by Abingworth and Blackstone Life Sciences (previously Clarus Ventures) and additional funding by Royalty Pharma.

For more information, please visit us at www.avillionllp.com

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.