- Pharma firm AstraZeneca reported positive results from a new asthma treatment it is developing in partnership with Avillion.

that positive high-level results from the MANDALA and DENALI Phase III trials of PT027 (albuterol/budesonide), at both 180/160mcg and 180/80mcg doses, met all primary endpoints demonstrating statistically significant benefits in patients with asthma versus individual components albuterol, also known as salbutamol (180mcg) and budesonide (160mcg).

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), being developed by AstraZeneca and Avillion.

The MANDALA trial met the primary endpoint, with PT027 demonstrating statistically significant and clinically meaningful reductions in the risk of severe exacerbations compared to albuterol, when used as a rescue medicine in response to symptoms. The trial included 3,132 patients with moderate to severe asthma taking maintenance ICS with or without additional controller medicines.

The DENALI trial met the dual primary endpoints, with PT027 showing a statistically significant improvement in lung function measured by forced expiratory volume in one second (FEV1), compared to the individual components albuterol and budesonide, and compared to placebo.

The trial included 1,001 patients with mild to moderate asthma previously treated either with a SABA as needed alone or in addition to low-dose maintenance ICS therapy.

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