PT027 is being developed through a partnership involving AstraZeneca and Avillion

Avillion LLP has announced that full results from the MANDALA phase 3 trial of AstraZeneca’s PT027 have been published

PT027 is a novel, fixed-dose combination of albuterol and budesonide. AstraZeneca’s drug, at two different strengths of budesonide, demonstrated a statistically significant reduction in the risk of a severe exacerbation versus albuterol rescue in patients with moderate- to severe asthma.

Over 176 million asthma attacks are experienced worldwide every year.

The results, published in The New England Journal of Medicine, will be presented at the American Thoracic Society (ATS) 2022 International conference.

Avillion is a drug development company focused on the co-development and financing of pharmaceutical candidates, from proof-of-concept through to regulatory approval.

“Building on the positive high-level results for MANDALA and DENALI announced in September last year, it’s fantastic to receive further confirmation of PT027’s potential in reducing the significant burden that asthma presents to millions of people worldwide,” Allison Jeynes, CEO of Avillion, said.“With the completion of this pivotal programme, Avillion maintains its 100% trial success rate across multiple therapy areas.

“This is an impressive achievement and demonstrates the power of our clinical co-development model and the quality of our international team in advancing vital drugs in partnership with pharma and biotech companies,” she added.

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

“We have enjoyed an excellent collaboration with AstraZeneca, under which we have delivered these large and complex trials during a pandemic and have ongoing regulatory responsibility for the NDA filing,” continued Jeynes.

“Furthermore, this partnership has recently expanded to include a new decentralised, randomised trial in patients with mild asthma, which is anticipated to kick off in the coming months.”