AstraZeneca's PT027 (Albuterol/Budesonide) Achieves Success in Two Phase III Trials: Significantly Improves Lung Function and Reduces Risk of Severe Exacerbations in Asthma Patients

September 11, 2021 /BioValleyBIOON/ --AstraZeneca(AstraZeneca) recently announced that from the Phase 3 MANDALA and DENALIClinical TrialThe high-level positive results indicate that,PT027 (albuterol/budesonide)The primary endpoint was met at both the 180/160 mcg and 180/80 mcg doses: compared with the individual components salbutamol (180 mcg) and budesonide (160 mcg),AsthmaPatients derived a statistically significant benefit.

PT027 is a potential first-in-class inhaled, fixed-dose combination product developed by AstraZeneca and Avillion,Composed of salbutamol (a short-acting β2-agonist [SABA]) and budesonide (an inhaled corticosteroid [ICS])。

The MANDALA trial met its primary endpoint:In patients with moderate-to-severe asthma, when used as a rescue medication for symptom relief, treatment with PT027 demonstrated a statistically and clinically significant reduction in the risk of severe exacerbations compared with salbutamol.This trial enrolled 3,132 patients with moderate-to-severe [condition] receiving ICS maintenance therapy (with or without other medications).AsthmaPatient.

The DENALI trial met its dual primary endpoints:In patients with mild-to-moderate asthma, treatment with PT027 resulted in a statistically significant improvement in lung function, as measured by forced expiratory volume in 1 second (FEV1), compared with its individual components, albuterol and budesonide, as well as with placebo.. This trial enrolled 1,001 patients with mild-to-moderate disease who had previously received as-needed SABA monotherapy or low-dose maintenance ICS therapy.AsthmaPatient.

The safety and tolerability of PT027 in the two trials were consistent with the known component profile. Detailed data from the MANDALA and DENALI trials will be presented at the upcoming medicalConferencepublished on.

Asthma is a chronic, inflammatory, and variable respiratory disease affecting up to 339 million adults and children worldwide, including more than 25 million in the United States.Inflammation is a prominent feature of asthma, inAsthmaplays a key role in symptoms, deterioration, and death.

American Allergy, Asthma andImmunologyFormer President, Medical Director of the Allergy and Respiratory Disease Center in Sacramento, USA, Bradley E. Chipps stated: "Severe asthma exacerbations affect many patients across all age groupsAsthmaposes a significant burden for patients, leading to a reduced quality of life, hospitalizations, systemic corticosteroid therapy (which may cause serious side effects), and the risk of premature death. Millions of patients worldwide rely on their rescue inhalers to relieve acute symptoms. The MANDALA and DENALI trials demonstrated that,The albuterol/budesonide rescue inhaler, which can reduce inflammation and prevent exacerbations, will make PT027 an important potential new treatment option for patients.。”

Mene Pangalos, Executive Vice President, BioPharmaceuticals R&D, AstraZeneca, stated: “All patients with asthma are at risk of severe exacerbations, regardless of disease severity, and many patients overuse short-acting bronchodilators. These exciting results with PT027 bring us one step closer to, by preventing asthma exacerbations, for”Asthmaprovides an innovative and superior treatment."

AsthmaPatients experience recurrent episodes of dyspnea and wheezing, varying in severity and frequency over time. Regardless of disease severity, treatment adherence, or level of control, these patients are at risk of severe exacerbations.

It is estimated that 176 million cases occur globally each yearAsthmadeterioration, with over 10 million cases in the United States; for many patients, these pose physical threats and significant emotional impacts, and can be fatal.

Inflammation is central to asthma symptoms and exacerbations. Many patients experiencing asthma symptoms use SABA as a rescue medication; however, SABA monotherapy does not address the underlying inflammation, leaving patients at risk of severe exacerbations. This can lead to impaired quality of life, hospitalization, and frequent use of oral corticosteroids (OCS). Repeated courses of OCS therapy are associated with systemic side effects (including pneumonia, osteoporosis, and type 2Diabetes mellitus) associated with an increased risk of. From globalAsthmaThe international recommendations from the Global Initiative for Asthma (GINA) no longer recommend SABA as the preferred rescue therapy. (Bioon.com)

Original Source:Fixed-dose combination of albuterol and budesonide (PT027) demonstrated significant benefits for asthma patients in MANDALA and DENALI Phase III trials