AstraZeneca reports positive data from PT027 fixed-dose combination trials
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.
Albuterol
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.
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.
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.
September 10th, 2021
https://www.clinicaltrialsarena.com/
