AstraZeneca has announced that the Phase 3 MANDALA and DENALI trials of PT027 albuterol (salbutamol)/budesonide MDI for the treatment of asthma both met their primary endpoints. The company has been co-developing PT027 with Avillion since 2018.
The MANDALA trial, which enrolled 3,132 patients who were using inhaled corticosteroids for moderate to severe asthma, demonstrated statistically significant reduction in severe exacerbations when used as a rescue inhaler compared to albuterol alone. The DENALI trial, which enrolled 1,001 patients who had been using either a SABA or a SABA and ICS for mild to moderate asthma, demonstrated statistically significant improvement in lung function compared to the the individual components and to placebo.
AstraZeneca Executive VP, BioPharmaceuticals R&D, Mene Pangalos commented, “All patients with asthma are at risk of severe exacerbations, regardless of their disease severity and many are known to overuse short-acting bronchodilators. These exciting results with PT027 bring us one step closer to providing an innovative and superior treatment approach for asthma by preventing exacerbations.”
Read the AstraZeneca press release.
