Insmed Incorporated, a people-first global biopharmaceutical company striving to deliver first- and best-in-class therapies to transform the lives of patients facing serious diseases, has officially published a total of 11 new abstracts at the American Thoracic Society (ATS) 2025 International Conference.
According to certain reports, this presentation included three pre-specified subgroup analyses from the Phase 3 ASPEN trial of brensocatib in non-cystic fibrosis bronchiectasis (NCFBE) that, on their part, relay the sheer consistency of efficacy and safety outcomes across diverse clinical profiles.
More on the same would reveal how Insmed’s three pre-specified subgroup analyses from ASPEN effectively revealed how brensocatib was able to reduce pulmonary exacerbations, prolong time to first exacerbation, and cut down on lung function decline.
“It is critical that we understand not only how brensocatib performed across the full ASPEN population, but also how it works within individual subgroups,” said James D. Chalmers, Professor of Respiratory Research, University of Dundee. “These new analyses offer evidence of consistent efficacy and safety in key patient types—including adolescents aged 12 and older, those receiving macrolide therapy, and individuals with various blood eosinophil levels—reinforcing the potential of brensocatib as a foundational treatment for this complex and heterogeneous disease.”
Talk about these subgroup analyses on a slightly deeper level, we begin from the one which had adolescents, a group where brensocatib 10 mg and 25 mg reduced annualized exacerbation rates vs placebo (annualized rates: 0.35 and 0.64 vs 0.87), with 59% of patients in both dose groups remaining exacerbation-free vs 35% on placebo.
Markedly enough, adolescent patients also experienced improvements in lung function as measured by forced expiratory volume in 1 second (FEV₁), while on either dose of brensocatib. On the other hand, patients in the placebo group experienced FEV1 decline.
The next group in line focused on maintaining macrolide use. Here, brensocatib would go on to showcase efficacy in patients, regardless of maintenance use of macrolides (without vs with). Furthermore, annualized exacerbation rates were deemed to be lower with brensocatib (10 mg: 0.97/1.21; 25 mg: 0.98/1.21) vs placebo (1.23/1.54), and a greater proportion remained exacerbation-free across subgroups. Brensocatib 25 mg also reduced FEV₁ achieving decline in both subgroups.
The final subgroup analyses revolved around gauging blood eosinophil level. This one saw Brensocatib 10 mg and 25 mg reducing annualized exacerbation rates, extending the time to first exacerbation, and bolstering the odds of remaining exacerbation-free in both subgroups of patients with high (≥300/mm3) or low (<300/mm3) blood eosinophil counts at baseline.
Brensocatib 25-mg, in particular, achieved reduced lung function decline, while simultaneously improving Quality of Life-Bronchiectasis Respiratory Symptoms Domain score (QOL-B RSS) at week 52 vs placebo regardless of baseline blood eosinophil count.
Insmed also took this opportunity to introduce a post-hoc analysis from ASPEN on lung function, health economics, and outcomes research, with the results treading up a long distance to relay the high burden of bronchiectasis on the healthcare system, as well as several other abstracts across the company’s portfolio.
Among other things, we ought to mention how the total number of active sites in ASPEN stood at 391 sites in 35 countries. Out of that, adult patients (ages 18 to 85 years) were randomized 1:1:1 and adolescent patients (ages 12 to <18 years) were randomized 2:2:1 for treatment with brensocatib 10 mg, brensocatib 25 mg, or placebo once daily for 52 weeks, followed by 4 weeks off treatment.
Apart from that, Insmed took this opportunity to reveal real-world comparative outcomes for patients treated with ARIKAYCE® (amikacin liposome inhalation suspension), along with data exploring longitudinal health status improvements after culture conversion in refractory Mycobacterium avium complex (MAC) lung disease.
“These new analyses from ASPEN—the largest Phase 3 trial in bronchiectasis to date—demonstrated consistent efficacy and safety across three key patient groups, reinforcing the potential of brensocatib to deliver meaningful clinical benefit where no approved treatments currently exist,” said Martina Flammer, Chief Medical Officer, Insmed. “The breadth and depth of our scientific contributions at ATS across our respiratory portfolio reflect our commitment and deep pride in advancing research that has the potential to transform care for patients with serious diseases.”
