AstraZeneca has revealed positive results from two Phase III trials of the fixed-dose combination of albuterol and budesonide – also known as PT027 – in patients with moderate-to-severe asthma.
PT027, which AZ is developing with Avillion, is a potentially first-in-class inhaled, fixed-dose combination of the short-acting beta2-agonist (SABA) albuterol, also known as salbutamol, and inhaled corticosteroid (ICS) budesonide.
Results from the MANDALA trial showed that PT027 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 DENALI trial also yield similarly positive results, with PT027 showing a statistically significant improvement in lung function measured by forced expiratory volume in one second (FEV1), compared to individual albuterol and budesonide treatment and compared to placebo.
“All patients with asthma are at risk of severe exacerbations, regardless of their disease severity and many are known to overuse short-acting bronchodilators,” said Mene Pangalos, executive vice president, BioPharmaceuticals R&D, AZ.
“These exciting results with PT027 bring us one step closer to providing an innovative and superior treatment approach for asthma by preventing exacerbations,” he added.
The detailed data from both the MANDALA and DENALI studies are set to be presented at an upcoming medical meeting, AZ said in a statement.