Avillion reports positive Phase III BATURA trial results for AstraZeneca's inhaled asthma drug Airsupra

Avillion Life Sciences Ltd has announced promising results from the ongoing BATURA Phase IIIb trial, which evaluates AstraZeneca's Airsupra (albuterol/budesonide) in patients with intermittent or mild persistent asthma. The trial met its primary endpoint, showing a statistically significant and clinically meaningful reduction in the risk of severe asthma exacerbations when used as an as-needed rescue medication compared to albuterol alone.

Conducted under an exclusive clinical co-development agreement between Avillion and AstraZeneca, the trial included patients with various levels of asthma severity, including those on short-acting beta2-agonist (SABA) alone, low-dose inhaled corticosteroid (ICS) maintenance therapy, or leukotriene receptor antagonist (LTRA) maintenance therapy.

Asthma is a chronic inflammatory respiratory disease affecting as many as 262 million people globally, including over 25 million in the US. At least 50% of these patients have mild asthma yet remain at risk of severe exacerbations. James Donohue, Emeritus Professor of Pulmonary Medicine at the University of North Carolina and Chair of the Independent Data Monitoring Committee, emphasized the importance of the study by stating that the risk of severe exacerbations persists regardless of disease severity or control level. The BATURA trial results underscore the clinically meaningful benefits of an anti-inflammatory rescue approach that treats both symptoms and inflammation concurrently.

Allison Jeynes, MD, CEO of Avillion, expressed excitement over the positive outcomes, attributing the success to the long-term collaboration with AstraZeneca. She highlighted that the results demonstrate the value of their clinical co-development model and the operational excellence of their international team, which has significantly contributed to bringing new therapy options to asthma patients.

The safety and tolerability of Airsupra in the BATURA trial were consistent with its established profile, with no new safety concerns reported. The data will be presented at the American College of Allergy, Asthma & Immunology (ACAAI) Annual Scientific Meeting on October 26, 2024.

Airsupra holds the distinction of being the first and only anti-inflammatory rescue medication approved in the US for the as-needed treatment or prevention of bronchoconstriction and for reducing the risk of exacerbations in people with asthma aged 18 and older. This approval was based on results from the MANDALA and DENALI Phase III trials. Further studies are being conducted in adolescents with asthma and in Chinese patients.

Sharon Barr, Executive Vice-President of BioPharmaceuticals R&D at AstraZeneca, remarked that the BATURA trial results bolster the evidence supporting Airsupra as a first-in-class rescue treatment. The trial further validates its role in reducing asthma exacerbations and the need for systemic corticosteroids, irrespective of the patient's disease severity.

In March 2018, Avillion and AstraZeneca signed an agreement to advance Airsupra through a global clinical development program for asthma treatment. Under this agreement, Avillion became the trial sponsor responsible for executing and funding the global, multicenter clinical trial program for Airsupra through the New Drug Application (NDA) filing to a regulatory decision in the US. Following Airsupra's successful approval, AstraZeneca took on the commercial responsibilities. In 2022, AstraZeneca extended its agreement with Avillion to conduct the BATURA Phase IIIb trial to further evaluate Airsupra's role in reducing asthma exacerbations.

The Airsupra clinical development program was funded by Blackstone Life Sciences, Royalty Pharma, and Abingworth. Avillion provides pharmaceutical partners with an innovative model that offers clinical development expertise and funding to maximize the potential of new and existing assets. With a proven track record, Avillion prides itself on its operational excellence and dedication to accelerating clinical development and delivering quality data, thereby enabling quicker access to new treatments for patients.

Founded in 2012 by Abingworth and Blackstone Life Sciences, with additional funding from Royalty Pharma, Avillion continues to work on exciting clinical development projects across multiple therapy areas.