Brensocatib is efficacious in patients with bronchiectasis and more than 2 annual exacerbations

Brensocatib, compared with placebo, demonstrated consistent efficacy in patients with severe bronchiectasis, according to a subgroup analysis of the phase 3 ASPEN trial.

The ASPEN trial (NCT04594369) was a phase 3, randomised, double-blind study in adults and adolescents with non-cystic fibrosis bronchiectasis. In this trial, participants were assigned (1:1:1 for adults and 2:2:1 for adolescents) to receive either daily brensocatib 10 mg, brensocatib 25 mg, or placebo. The total number of enrolled participants was 1,721 [1]. The subgroup analysis, presented by Prof. Michael Loebinger (Royal Brompton Hospital, UK), focused on patients with ≥3 versus 2 exacerbations in the 12 months prior to screening [2].

Both brensocatib doses reduced the number of pulmonary exacerbations versus placebo, regardless of baseline exacerbation frequency. Among patients with 2 exacerbations, the annualised exacerbation rates were 0.80, 0.86, and 1.10 following treatment with 10 mg, 25 mg, and placebo, respectively, while for patients with ≥3 exacerbations, the rates were 1.73, 1.64, and 1.94, respectively. Furthermore, post-bronchodilator forced expiratory volume in 1 second (FEV1) decline was attenuated with brensocatib 25 mg compared with placebo, independent of prior exacerbation history. The rate of adverse events (AEs) and serious AEs was higher in the subgroup with ≥3 exacerbations, primarily due to an increased incidence of infections.

“The post-hoc analysis confirmed that treatment effects were consistent across patients with ≥3 or 2 prior exacerbations and aligned with the overall ASPEN study,” concluded Prof. Loebinger.

1. Chalmers JD, et al. N Engl J Med. 2025;392(16):1569-1581.
2. Loebinger M, et al. Efficacy and safety of brensocatib in patients with non-cystic fibrosis bronchiectasis by exacerbation history: Analysis of the ASPEN trial. ERS Congress, 27 September–1 October 2025, Amsterdam, the Netherlands.

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Posted on 30 October 202530 October 2025