AstraZeneca's Two Asthma Trials Meet Primary Endpoints

Avillion LLP announces positive topline results from the MANDALA and DENALI Phase 3 trials of PT027 in asthma patients.
PT027 is an inhaled, fixed-dose combination of albuterol and budesonide developed by AstraZeneca Plc AZN and Avillion.
The trials met all primary endpoints at both 180/160mcg and 180/80mcg doses and demonstrated statistically significant benefits versus individual albuterol and budesonide components.
The PT027 clinical co-development program was funded by Blackstone Life Sciences, Royalty Pharma RPRX, and Abingworth.
The MANDALA trial demonstrated 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 taking maintenance inhaled corticosteroid (ICS) with or without additional controller medicines.
The DENALI trial showed a statistically significant improvement in lung function compared to the individual components and placebo.
The trial included 1,001 patients previously treated either with a SABA as needed alone or in addition to low-dose maintenance ICS therapy.
The safety and tolerability of PT027 in both trials were consistent with the known profiles of the components.
Detailed data from the trial will be presented at an upcoming medical meeting.
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