U.S. FDA Accepts Avillion’s New Drug Application for AstraZeneca’s PT027 for As-needed Treatment or Prevention of Symptoms in Patients with Asthma

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  • Results from phase III trials conducted by Avillion in more than 4,000 patients show that PT027, a novel fixed-dose combination of albuterol and budesonide, significantly reduces the risk of severe asthma exacerbation compared to albuterol alone
  • Avillion Announces Expansion of Partnership with AstraZeneca on PT027 and Will Fund and Execute New Phase 3b study

LONDON, May 31, 2022 /PRNewswire/ — Avillion LLP, a drug development company focused on co-developing and funding drug candidates from proof of concept to regulatory approval, announces that the United States Food and Drug Administration (FDA) United States has agreed to file Avillion’s New Drug Application (NDA) for AstraZeneca’s PT027. The proposed indication is for the treatment or prevention as needed of bronchoconstriction and for the prevention of exacerbations in asthmatic patients aged 4 years and older.

PT027 is a first-in-class, potentially inhaled, fixed-dose combination of albuterol, a short-acting beta2-agonist (SABA), and budesonide, an inhaled corticosteroid (ICS), in the United States under development by Avillion and AstraZeneca under a 2018 clinical co-development agreement.

Under the terms of the agreement, Avillion funded, sponsored and executed a global, multicenter clinical trial program for PT027 comprising four studies involving more than 4,000 patients. Avillion also has regulatory responsibility, including the filing of the NDA until a regulatory decision in the United States. Following the successful approval of PT027, AstraZeneca has the option, for certain financial payments, to market the drug in the United States.

The NDA submission is based on data from studies conducted by AstraZeneca and Avillion to assess the safety and efficacy of PT027. Positive results from the main phase III study, MANDALA, were recently published in the New England Journal of Medicine and presented at the 2022 American Thoracic Society (ATS) International Conference (May 13-18, 2022). PT027 at two different strengths of budesonide, used as rescue medication as needed, demonstrated a statistically significant reduction in the risk of severe exacerbation compared to albuterol rescue in patients with moderate to severe asthma.1.2

The co-development partnership between AstraZeneca and Avillion recently expanded to include the BATURA study, a randomized phase 3b decentralized trial to further assess the role of PT027 in preventing asthma exacerbations.

Allison JeynesMD, CEO of Avillion, said: “Our clinical studies have demonstrated the strong potential of PT027 to make a significant contribution to the care of asthma patients, and we are delighted to file this NDA and achieve a key milestone in what continues to be an excellent partnership with AstraZeneca Throughout our various clinical co-development collaborations, Avillion has maintained a 100% trial success rate across multiple therapeutic areas, and the evolution of our model to include regulatory filing responsibilities further demonstrates the strong value that we can bring to partner companies to continue working with AstraZeneca as PT027 progresses through the regulatory process and as we prepare to launch the BATURA study as part of an extended partnership.”

Remarks

Asthma

Asthma is a chronic, inflammatory and variable respiratory disease that affects up to 339 million adults and children worldwide,3 including more than 25 million in the United States.4

Patients with asthma present with recurrent shortness of breath and wheezing, which vary in time, severity, and frequency.5 These patients are at risk of severe exacerbations regardless of disease severity, treatment compliance, or level of control.6.7

There are an estimated 176 million asthma exacerbations worldwide each year,8 including more than 10 million in the United States;4 these are physically threatening and emotionally significant for many patients9 and can be fatal.3.10

Inflammation is at the heart of both asthma symptoms5 and exacerbations.11 Many patients with asthma symptoms use SABA as rescue medication, however, taking SABA alone does not treat inflammation, leaving patients at risk for severe exacerbations.12 which can lead to impaired quality of life,13 hospitalization14 and frequent use of oral corticosteroids (OCS).13 Treating exacerbations with as little as 1-2 short cycles of OCS is associated with an increased risk of adverse health conditions including type 2 diabetes, depression/anxiety, kidney failure, cataracts, cardiovascular diseases, pneumonia and fractures.5,15,16 International guidelines from the Global Initiative for Asthma no longer recommend SABA alone as the preferred rescue therapy.5

About Avillion

Avillion offers pharmaceutical partners an innovative model offering additional funding and clinical development expertise, to maximize the potential of new and existing assets. With transactions ranging from $50 million to $600 million, Avillion assumes all clinical and regulatory risk, focusing on the speed and quality of trial execution. Typically supporting post-proof-of-concept programs through registration and with a therapeutic area agnostic approach, Avillion prides itself on adding value around operational expertise while being backed by established long-term investors. .

Avillion was founded in 2012 and is backed by Abingworth and Blackstone Life Sciences (formerly Clarus Ventures). The PT027 clinical co-development program was funded by Blackstone Life Sciences, Royalty Pharma and Abingworth.

For more information visit us at www.avillionllp.com

References

1. Papi A, et al. Albuterol-budesonide fixed-dose combination reliever inhaler for asthma. N Eng J Med. 2022; May 15. DOI: 10.1056/NEJMoa2203163. Online ahead of print

2. Papi A, et al. Efficacy and safety of albuterol/budesonide as-needed versus albuterol as-needed in adults, adolescents, and children aged ≥ 4 years with moderate to severe asthma: results from the MANDALA study. American Thoracic Society International Conference 2022. Oral presentation.

3. Chipps BE, et al. Efficacy and safety of albuterol/budesonide (PT027) in mild to moderate asthma: results of the DENALI study. American Thoracic Society International Conference 2022. Abstract. Available at: https://www.abstractsonline.com/pp8/#!/10476/presentation/7832 [Last accessed 15 May 2022].

4. The Global Asthma Network. The World Asthma Report 2018. [Online]. Available at: http://www.globalasthmarreport.org/Global%20Asthma%20Report%202018.pdf. [Last accessed: 4 May 2022].

5. CDC. Most recent national asthma data. [Online]/ Available at: https://www.cdc.gov/asthma/most_recent_national_asthma_data.htm. [Last accessed: 4 May 2022].

6. Global Asthma Initiative. GINA Report 2021, Global Strategy for the Management and Prevention of Asthma. [Online]. Available at: https://ginasthma.org/wp-content/uploads/2021/04/GINA-2021-Main-Report_FINAL_21_04_28-WMS.pdf [Last accessed: 4 May 2022]

7. Price D, et al. Asthma control and management in 8000 European patients: the Asthma Recognition and Link to Symptoms and Experience (REALISE) survey. NPJ Prim Care Respir Med. 2014 ; 24:14009.

8. Papi A, et al. Relationship between adherence to inhaled corticosteroids and asthma exacerbations in patients with moderate to severe asthma. J Allergy Clin Immunol Pract. 2018; 6(6):1989-98.e3.

9. Sastre J, et al. Ideas, attitudes and perceptions about asthma and its treatment: a multinational survey of patients from Europe and Canada. World Allergy Organ J. 2016; 9:13 a.m.

10. Fernandes AG, et al. Risk factors for death in patients with severe asthma. J Pneumol arm. 2014 ; 40 (4): 364-372

11. Wark PA, et al. Asthma exacerbations· 3: pathogenesis. Thorax. 2006; 61 (10): 909-15.

12. Nwaru BI, et al. Overuse of short-acting β2-agonists in asthma is associated with an increased risk of exacerbation and mortality: a national cohort study of the global SABINA program. Eur Respir J. 2020; 55 (4): 1901872.

13. 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.

14. Bourdin A, et al. ERS/EAACI statement on severe asthma exacerbations in adults: facts, priorities and key research questions. Eur Respir J. 2019; 54 (3): 1900900.

15. DB Price, et al. Adverse effects of initiating systemic corticosteroids for asthma: a long-term observational study. J Asthma Allergy. 2018; 11: 193–204.

16. EPR-3: Report of Expert Group 3. Guidelines for the diagnosis and management of asthma 2007 (EPR-3). [Online]. Available at: https://www.nhlbi.nih.gov/health-topics/guidelines-for-diagnosis-management-of-asthma. [Last accessed: 4 May 2022].

SOURCEAvillion LLP


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