Phase 3 Trials Show Benefits of Albuterol, Budesonide Drug

PT0271, an albuterol/budesonide, showed statistically significant benefits in individuals with asthma, with both the 180/160mcg and 180/180mcg doses, results from the MANDALA and DENALI phase 3 trials showed.

“Severe asthma exacerbations are a significant burden for many asthma patients of all ages, resulting in impaired quality of life, hospitalization, treatment with systemic corticosteroids which can lead to serious side effects, and the possibility of premature death. Many millions of patients globally rely on their rescue inhaler to alleviate acute symptoms, but this does not treat the underlying inflammation in asthma,” Bradley Chipps, past president of the American College of Allergy, Asthma & Immunology and medical director of Capital Allergy & Respiratory Disease Center in Sacramento, California, said in a statement. “The MANDALA and DENALI trials demonstrate an albuterol/budesonide rescue inhaler can address inflammation and prevent exacerbations, making PT027 an important potential new treatment option for patients.”

The DENALI trial included 1001 individuals with mild to moderate asthma who were previously treated with a short-acting β-agonist as needed or with low-dose maintenance inhaled corticosteroid (ICS) therapy. PT027 also showed statistically significant improvement in lung function by expiratory volume in 1 second compared with albuterol and budesonide, individually, and the placebo, the results of the DENALI trial showed.

The MANDALA trial included 3132 individuals with moderate to severe asthma taking maintenance ICS with or without additional medications. The results of the MANDALA trial showed that PT027, developed by AstraZeneca and Avillion, reduced the risk of severe exacerbations compared with albuterol when used as a rescue medication.

“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 1 step closer to providing an innovative and superior treatment approach for asthma by preventing exacerbations,” Mene Pangalos, BioPharmaceuticals R&D’s executive vice president, said in the statement.

Both trials were consistent with the known safety and tolerability profiles.

Reference

Fixed-dose combination of albuterol and budesonide (PT027) demonstrated significant benefits for asthma patients in MANDALA and DENALI phase III trials. Business Wire. News release. September 9, 2021. Accessed September 10, 2021. https://www.businesswire.com/news/home/20210909005330/en