AstraZeneca asthma products perform well in phase 3 trials

AstraZeneca said on Thursday that positive high-level results from the ‘MANDALA’ and ‘DENALI’ phase 3 trials of PT027, or albuterol/budesonide, at both 180/160mcg and 180/80mcg doses, met all primary endpoints.

The FTSE 100 drugmaker said it demonstrated “statistically significant” benefits in patients with asthma versus individual components of albuterol, also known as salbutamol.and budesonide.

It described PT027 as 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 its 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.

AstraZeneca said the trial included 3,132 patients with moderate to severe asthma taking maintenance ICS with or without additional controller medicines.

The DENALI trial, meanwhile, 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.

“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 executive vice-president of biopharmaceuticals research and development Mene Pangalos.

“These exciting results with PT027 bring us one step closer to providing an innovative and superior treatment approach for asthma by preventing exacerbations."

The safety and tolerability of PT027 in both trials were consistent with the known profiles of the components, AstraZeneca confirmed.

At 0920 BST, shares in AstraZeneca were down 0.95% at 8,236.13p.