AstraZeneca and Avillion have announced that the Phase 3b BATURA trial of Airsupra albuterol / budesonide MDI as a rescue inhaler in patients with mild asthma met its primary endpoint of reduction in risk of severe exacerbation compared to albuterol alone. The companies say that the independent data monitoring committee recommended an early termination of the trial “due to overwhelming efficacy at pre-planned analysis.” Data from the BATURA study will be presented at the upcoming meeting of the American College of Allergy, Asthma & Immunology.
The trial, which was initiated in 2022, enrolled more than 2500 patients aged 12 and up. In January 2023, the FDA approved Airsupra (formerly PT027) for the treatment of asthma in patients aged 18 and over. The NDA was supported by data from the Phase 3 MANDALA and DENALI trials, which were completed in 2021. The companies note that the Phase 3 ACADIA trial of Airsupra in adolescents and the Phase 3 BAIYUN trial in China are ongoing.
AstraZeneca Executive VP, BioPharmaceuticals R&D, Sharon Barr commented, “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.”
Avillion CEO Allison Jeynes 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.”
Read the Avillion press release.
Read the AstraZeneca press release.
