AstraZeneca (AZ) and Avillion have announced positive phase 3 trial results from the MANDALA study, showing that PT027 – albuterol/budesonide – demonstrated a statistically significant decrease in the risk of a severe exacerbation, compared to albuterol alone, for patients with moderate to severe asthma.
PT027, a potential first-in-class, inhaled, fixed-dose combination of albuterol – a short-acting beta-agonist (SABA) – and budesonide are being developed for the treatment of asthma patients as an ‘as-needed’ rescue medicine.
Mene Pangalos, executive vice president, bioPharmaceuticals R&D at AstraZeneca, said: “Asthma is an inflammatory, variable disease and patients are at risk of experiencing a severe exacerbation regardless of disease severity and adherence to treatment. The results from the phase 3 trials support the clinical benefit of PT027, an albuterol/budesonide rescue inhaler, which has the potential to be a first-in-class treatment approach that can prevent asthma attacks over and above their current maintenance therapies.”
More than 176 million asthma attacks are experienced each year worldwide.
During the trial, patients were randomised to receive either PT027 or albuterol rescue, in addition to their usually prescribed maintenance ICS, with or without additional controller medicines.
In secondary endpoints, PT027 (180mcg albuterol/160mcg budesonide) showed a 33% reduction in mean annualised total systemic corticosteroid exposure and a 24% reduction in annualised severe exacerbation rate.
After 24 weeks of treatment with PT027, patients were more likely to experience improved symptom control and quality of life than compared to albuterol alone.
It is estimated that around 176 million asthma exacerbations occur globally each year, which can prove fatal.
Bradley Chipps, past president of the American College of Allergy, Asthma & Immunology and medical director of the Capital Allergy & Respiratory Disease Center in the US, said: “This data further strengthens the growing body of evidence around the value of as-needed anti-inflammatory treatment in asthma and support PT027’s potential to transform the current rescue treatment approach.”
The results of the MANDALA trial were published in The New England Journal of Medicine and are scheduled to be presented at the American Thoracic Society (ATS) 2022 International Conference.