Months after touting some fuzzy top-line readouts, AstraZeneca and its biotech partner Avilian are today detailing the data they’re taking to regulators for their asthma drug.
Candid PT027 is an inhaled, fixed-dose rescue drug containing albuterol, a common asthma treatment consisting of a short-acting beta 2-agonist (SABA), and budesonide – an inhaled and commonly used corticosteroid.
For their Phase III trial, called Mandala, the primary endpoint was the time to first severe asthma exacerbation during the treatment period. The data showed that compared to albuterol rescue alone, PT027 reduced the risk of an acute stimulus by 27% (p<0.001) in adults and adolescents. In the trial, patients were randomized to receive PT027 or albuterol rescue, on top of their commonly prescribed maintenance ICS, with or without additional controller medications.
Secondary endpoints included severe exacerbation rate, total systemic corticosteroid exposure and health-related quality of life. The candidate triggered a 33% reduction in mean annual total systemic corticosteroid exposure (p = 0.002) and a 24% reduction in annual severe exacerbation rate (p = 0.008).
The researchers also noted that more patients experienced improvement in symptom control and quality of life after 24 weeks of treatment with PT027 compared to albuterol rescue. Adverse events were similar across treatment groups, with the most common effects being nasopharyngitis and headache.
Results were posted in New England Journal of Medicine.
Mayne Pangalos, executive vice president of biopharmaceuticals R&D at AstraZeneca, says the data point to the combo’s potential to be “a first-in-class treatment approach that can prevent asthma attacks over and above their current maintenance therapies.”
AstraZeneca, based on these figures, expects to file for approval sometime later this year.
The relationship between AstraZeneca and British company Avilion began in March of 2018 when the two companies signed an agreement to advance PT027.
Albuterol itself has been the standard of care for the treatment of acute asthma symptoms, but it has not been used to treat the underlying inflammation associated with asthma, where patients become more dependent on their albuterol inhaler and no relief from symptoms. Meena Makar, AstraZeneca senior VP for respiratory and immunology, previously reported endpoint news,
PT027 expects that by adding inhaled corticosteroids to albuterol as part of rescue therapy, patients will be more likely to avoid hospitalization with severe attacks and the need for oral steroids. This strategy has been shown to be safe among other asthma maintenance supplements, including Symbicort and Trelagi.
The PT027 program was funded by Blackstone Life Sciences, Royalty Pharma and Ebbingworth, three players known to act of late in exchange for market action.