The New England Journal of Medicine has published the results of Avillion and AstraZeneca’s PT027 after participation in the MANDALA Phase III trial. The full results from the trial show promise for the treatment of moderate to severe asthma.
The two companies have been working on the development of asthma treatment since 2018. The treatment is a combination dose of albuterol and budesonide.
Avillion and AstraZeneca made the announcement for the results of the phase III MANDALA study after receiving statistically significant positive results from the study. PT207, the albuterol budesonide combination shows promise to become a rescue treatment for asthma patients.
PT027 demonstrated significantly better results in the decrease of the seriousness of an asthma attack when compared to the use of albuterol as a lone treatment.
Explaining the benefit of the treatment for asthma patients, an AstraZeneca VP stated “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.”
PT207 has the potential to be the first of its kind inhaled combo treatment for asthma. Albuterol is a short-acting beta-agonist (SABA) along with budesonide, a corticosteroid. Together, they can become the newest in class rescue treatment for asthma, to be used when needed by patients suffering from moderate to severe asthma.
The MANDALA trial results show that PT027 reduces the risk of exacerbation of asthma by over 20%.
The trial was randomized and the results obtained were in comparison to albuterol alone with the prescribed treatment of ICS being continued by patients.
PT027 with a combination of 180mg albuterol and 160mcg budesonide showed over 30% in the average annualized total systemic corticosteroid exposure.
Patients experienced an improvement in the quality of life and symptom control with the use of PT027 treatment after a span of 24 weeks.
The agreement between the partners stipulates that Avillion will be the sponsor of the complete funding of the trial. AstraZeneca holds the option to commercialize the treatment in the U.S., constrained by some financial payments. An Avillion representative exclaimed that after the successful completion of the PT027 trial the company continues to maintain its perfect success rate for trials. The representative further revealed that a randomized trial for the treatment of mild asthma is likely to begin in a few months.
The MANDALA trial showed that safety profiles were consistent across treatment groups and adverse events were similar.
Over 170 million asthma attacks are experienced by the global population, which the developed treatment hopes to help.
Bradley Chipps, the Capital Allergy & Respiratory Disease Center’s Medical Director stated that the trial data builds upon and reinforces the current evidence of as-needed treatment of asthma. Further explaining that the combo drug may prove transformative in the area of transformative rescue treatment for asthma.
The trial results will be presented at the American Thoracic Society International Conference 2022.