US FDA accepts New Drug Application filed by Avillion for AstraZeneca’s PT027 for the as-needed treatment or prevention of symptoms in asthma patients

• Results from Phase III trials conducted by Avillion in over 4,000 patients show that PT027, a novel fixed-dose combination of albuterol and budesonide, significantly reduced the risk of a severe asthma exacerbation compared to albuterol alone
• Avillion announces expansion of partnership with AstraZeneca on PT027 and will fund and execute a new Phase 3b study

London, UK, 31 May 2022 – Avillion LLP, a drug development company focused on the co-development and financing of pharmaceutical candidates from proof-of-concept through to regulatory approval, announces that the US Food and Drug Administration (FDA) has accepted for filing Avillion’s New Drug Application (NDA) for AstraZeneca’s PT027. The proposed indication is for the as-needed treatment or prevention of bronchoconstriction and for the prevention of exacerbations in patients with asthma 4 years of age and older.

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

Under the terms of the agreement, Avillion funded, sponsored, and executed a multicentre, global clinical trial programme for PT027 comprising four studies involving more than 4,000 patients. Avillion also has regulatory responsibility including filing the NDA through to a regulatory decision in the US. Following the successful approval of PT027, AstraZeneca has the option, upon certain financial payments, to commercialise the medicine in the US.

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 lead Phase III study, MANDALA, were recently published in the New England Journal of Medicine and presented at the American Thoracic Society (ATS) 2022 International Conference (13-18 May 2022).  PT027 at two different strengths of budesonide, used as an as-needed rescue medicine, demonstrated a statistically significant reduction in the risk of a severe exacerbation versus albuterol rescue in patients with moderate to severe asthma.^1,2

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

Allison Jeynes, MD, Chief Executive Officer of Avillion, said: “Our clinical studies have demonstrated the strong potential of PT027 in providing a meaningful contribution to patient care in asthma, and we’re pleased to be making this NDA filing and reaching 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 therapy areas, and the evolution of our model to include regulatory filing responsibilities further demonstrates the strong value we can provide to partner companies. We’re excited 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 expansion to the partnership.”