AstraZeneca, Avillion's asthma inhaler therapy PT027 reduces exacerbations in phase 3 trial
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AstraZeneca (NASDAQ:AZN) said full results from a late stage study of its inhaled asthma therapy PT027 showed that the rescue medication helped reduce severe exacerbations by 27%.
The British drugmaker said PT027 is a potential first-in-class inhaled, fixed-dose combination rescue treatment containing albuterol, a short-acting beta2-agonist, and inhaled corticosteroid (ICS) budesonide, in the U.S. which is being developed along with Avillion.
The company said full results from the phase 3 trial called MANDALA, which had met its main goal last year, showed that PT027 at two different strengths of budesonide, used as an as-needed rescue medicine, showed a statistically significant reduction in the risk of a severe exacerbation versus albuterol rescue in patients with moderate to severe asthma.
Compared with albuterol rescue, PT027 at 180-mcg albuterol/160-mcg budesonide dose reduced the risk of a severe exacerbation by 27% in adults and adolescents.
In the trial, patients (3,132 adults, adolescents, and children aged four years to 11 years) with moderate to severe asthma received PT027 or albuterol rescue, in addition to their usually prescribed maintenance ICS, with or without additional controller drugs.
AstraZeneca (AZN) added that in secondary goals, PT027 showed a 33% reduction in mean annualized total systemic corticosteroid exposure and a 24% reduction in annualized severe exacerbation rate.
The company noted that PT027 at a lower budesonide dose (180mcg albuterol/80mcg budesonide), also showed a statistically significant reduction of 17% in the risk of severe exacerbation versus albuterol rescue, when used as an as-needed rescue medicine in adults, adolescents, and children aged four years to 11 years.
"The results from these Phase III 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," said Mene Pangalos, executive vice president, BioPharmaceuticals R&D, AstraZeneca.
The company noted that adverse events were similar across the treatment groups.