AstraZeneca’s asthma drug reveals success in Phase III trials

pharmafile | September 9, 2021 | News story | |   

Avillion have announced the success of the MANDALA and DENALI Phase III trials of AstraZeneca’s PT027 (albuterol/budesonide), which revealed the efficacy of the medicine in treating asthma. The data from the DENALI trial revealed that the fixed-dose combination improves lung function in mild to moderate asthma patients. The MANDALA trial showed that the PT027 reduced exacerbations for moderate to severe asthma, when used as a rescue medicine.

According to the Phase III trials, the combination of albuterol and budesonide, in 180/160mcg and 180/80mcg doses, reaped more health benefits than taking the individual components by themselves.

With an estimated 176 million asthma exacerbations globally each year, denoting instances of severe asthma attacks, it is vital that new, innovative treatment options are sought out. Mene Pangalos, Executive Vice President, BioPharmaceutical R&D at Astrazeneca, said: “All patients with asthma are at risk of severe exacerbations, regardless of their disease severity.”

PT027 is an inhaled, fixed-dose combination of albuterol, and budesonide, an inhaled corticosteroid. Astrazeneca now has the opportunity to commercialise the medicine in the US.

Bradley E Chipps, past president of the American College of Allergy, Asthma and Immunology and Medical Director of Capital Allergy and Respiratory Disease Center in Sacramento, US, says: “Millions of patients globally rely on their rescue inhaler to alleviate acute symptoms, but this does not treat the underlying inflammation in asthma.

“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.”

Lina Adams

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