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Avillion announces positive high-level results from Phase III BATURA trial with AstraZeneca's inhaled anti-inflammatory medication Airsupra in asthma patients
AZNAstraZeneca(AZN) GlobeNewswire News Room·2024-10-07 06:08

Core Insights - The BATURA Phase IIIb trial for AstraZeneca's Airsupra (albuterol/budesonide) has shown positive results, demonstrating a statistically significant reduction in the risk of severe asthma exacerbations compared to albuterol alone [1][2][3] - Airsupra is the first anti-inflammatory rescue medication approved in the US for asthma treatment, targeting patients aged 18 and older [3][8] - The trial included patients with intermittent or mild persistent asthma, highlighting the need for effective treatments in this population [2][7] Company Collaboration - Avillion Life Sciences conducted the BATURA trial under an exclusive co-development agreement with AstraZeneca, which has been in place since March 2018 [5][9] - The collaboration has been extended to further assess Airsupra's role in reducing asthma exacerbations, showcasing the value of their clinical co-development model [5][9] Clinical Development - The BATURA trial involved a randomized, double-blind design, comparing inhaled albuterol/budesonide as a rescue medication against albuterol alone for up to 12 months [7] - The primary endpoint was the time to first severe asthma exacerbation, with secondary endpoints including severe exacerbation rate and total systemic corticosteroid use [7] Market Context - Asthma affects approximately 262 million people globally, with over 25 million in the US, indicating a significant market for effective treatments [2][6] - Patients with mild asthma represent at least 50% of the US asthma population, emphasizing the importance of addressing their treatment needs [2][6] Future Directions - Airsupra is also being studied in adolescents and patients in China, indicating ongoing research and potential market expansion [3][8] - The positive results from the BATURA trial will be presented at the American College of Allergy, Asthma & Immunology Annual Scientific Meeting, further promoting the drug's profile [2]