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September 10, 2021

AstraZeneca reports positive data from PT027 fixed-dose combination trials

PT027 met all primary goals of the two trials and offered statistically significant benefits in asthma patients.

AstraZeneca has reported positive high-level data from Phase III MANDALA and DENALI clinical trials of its combination treatment, PT027, in asthma patients.

Being developed by AstraZeneca along with Avillion, PT027 is an inhaled, fixed-dose combination of a short-acting beta2-agonist (SABA), albuterol and an inhaled corticosteroid (ICS), budesonide.

Data showed that PT027 administered at 180/160mcg as well as 180/80mcg doses met all primary endpoints showing statistically significant benefits in asthma patients as against individual components, 180mcg albuterol (salbutamol) and 160mcg budesonide.

The randomised, double-blind, multicentre, parallel-group, event-driven Phase III MANDALA trial assessed the efficacy and safety of PT027 versus albuterol on the time to first severe asthma exacerbation.

It enrolled 3,132 adults and children aged four years or above with moderate to severe asthma receiving ICS alone or along with various asthma maintenance treatments.

This trial met the primary endpoint with PT027 showing a statistically significant and clinically meaningful decline in the risk of severe exacerbations versus albuterol when used as a rescue treatment in response to symptoms.

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The randomised, double-blind, placebo-controlled, multicentre, parallel-group Phase III DENALI trial assessed the efficacy and safety of PT027 against its components albuterol and budesonide on lung function improvement.

It enrolled a total of 1,001 adults and children aged four years or above with mild to moderate asthma already treated with either SABA as needed alone or in addition to regular low-dose ICS maintenance therapy.

This trial met the dual primary endpoints, with PT027 demonstrating a statistically significant improvement in lung function as assessed by forced expiratory volume in one second (FEV1), versus the individual components albuterol and budesonide or placebo.

In both trials, PT027 was shown to have a safety and tolerability profile that was in line with already known profiles of the components.

AstraZeneca BioPharmaceuticals R&D executive vice-president Mene Pangalos said: “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.”

Last month, AstraZeneca reported positive data from the Phase III PROVENT trial of its antibody combination, AZD7442, for the prevention of Covid-19.

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