AstraZeneca: Phase III trials of MANDALA and DENALI in PT027 for asthma meet all primary goals
(RTTNews) – AstraZeneca PLC (AZN, AZN.L) announced Thursday that the phase III trials MANDALA and DENALI of a fixed-dose combination of albuterol and budesonide or PT027 have met all primary endpoints.
The company stated that PT027 (albuterol / budesonide), at doses of 180/160 mcg and 180/80 mcg, demonstrated significant benefits for patients with asthma in both trials, compared to the individual components of albuterol, also known as salbutamol (180 mcg) and budesonide (160 mcg).
PT027 is a potential combination of albuterol, a short-acting beta2-agonist (SABA), and budesonide, an inhaled corticosteroid (ICS). It is developed by AstraZeneca and Avillion.
Asthma is a chronic, inflammatory and fluctuating respiratory disease that affects up to 339 million adults and children worldwide.
In the MANDALA trial, PT027 significantly reduced the risk of severe exacerbations compared to albuterol in patients with moderate to severe asthma when used as a rescue medication in response to symptoms. The trial included 3,132 patients with moderate to severe asthma taking maintenance ICSs with or without additional control drugs.
Additionally, PT027 significantly improved lung function compared to the individual components in mild to moderate asthma in the DENALI trial. The trial included 1,001 patients with mild to moderate asthma previously treated either with BACA as needed alone or in addition to maintenance therapy with low dose ICS.
The company noted that the safety and tolerability of PT027 in both trials corresponded to known component profiles.
The company will present detailed data from MANDALA and DENALI at an upcoming medical meeting.
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