AstraZeneca and Avillion Report Positive Phase 3 Results for Asthma Treatment Airsupra

AstraZeneca (AZ) and Avillion have announced promising outcomes from a phase 3b clinical trial evaluating their inhaled anti-inflammatory rescue medication, Airsupra, in asthma patients aged 12 and above. The study indicated that Airsupra (a combination of albuterol and budesonide) significantly reduced the risk of severe asthma exacerbations when used as an as-needed rescue medication, compared to albuterol alone. This finding marks the achievement of the primary endpoint of the trial.

The BATURA study involved asthmatic patients with either intermittent or mild persistent asthma. Participants included those using short-acting beta2-agonists (SABAs) alone, those on low-dose inhaled corticosteroid maintenance therapy, and those on leukotriene receptor antagonist maintenance therapy. The results showed that Airsupra not only met safety and tolerability standards consistent with its established profile, but also demonstrated such "overwhelming efficacy" that an independent data monitoring committee recommended an early conclusion to the trial based on a pre-planned analysis.

Asthma, a chronic inflammatory disease affecting up to 262 million people globally, manifests through symptoms like recurrent breathlessness, wheezing, and chest tightness. Patients with asthma are continually at risk of severe exacerbations, irrespective of disease severity, treatment adherence, or level of control. It is estimated that there are around 136 million asthma exacerbations globally each year.

Many asthma sufferers rely on SABAs like albuterol as rescue medications to alleviate immediate symptoms. However, using SABAs alone does not address underlying inflammation, leaving patients vulnerable to severe exacerbations. In January 2023, Airsupra became the first and only anti-inflammatory rescue medication approved in the United States for as-needed treatment or prevention of bronchoconstriction and to reduce exacerbation risks in individuals aged 18 and older with asthma.

Sharon Barr, Executive Vice-President of Biopharmaceuticals Research and Development at AstraZeneca, emphasized that these latest results contribute to the growing body of evidence supporting Airsupra as a pioneering rescue treatment. Barr highlighted its role in decreasing asthma exacerbation risks across patients with varying disease severity and reducing the need for systemic corticosteroids.

The new data from the trial will be shared with health authorities and presented at the American College of Allergy, Asthma, and Immunology Annual Scientific Meeting this year.