Brensocatib Shows Strong Results in Key ASPEN Subgroups

Insmed Presented 11 Abstracts at ATS 2025 from Across Its Respiratory Portfolio, Including Data on ARIKAYCE, TPIP and Health Economics and Outcomes Research

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, presented 11 new abstracts at the American Thoracic Society 2025 International Conference, which took place May 18-21 in San Francisco, including three prespecified subgroup analyses from the Phase 3 ASPEN trial of brensocatib in non-cystic fibrosis bronchiectasis , signaling the consistency of efficacy and safety outcomes across diverse clinical profiles.

“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, MBChB, Ph.D., 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.”

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ASPEN Study Prespecified Subgroup Analyses
Three prespecified subgroup analyses from ASPEN showed brensocatib reduced pulmonary exacerbations, prolonged time to first exacerbation, and reduced lung function decline compared with placebo with a similar safety profile as the overall trial in the following populations:

• Adolescents: In adolescents, 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. Adolescent patients also experienced improvements in lung function as measured by forced expiratory volume in 1 second (FEV₁), while on either dose of brensocatib, while patients in the placebo group experienced FEV₁ decline.
• Maintenance macrolide use: Brensocatib demonstrated efficacy in patients regardless of maintenance use of macrolides (without vs with). Annualized exacerbation rates were 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 decline in both subgroups.
• Blood eosinophil level: Brensocatib 10 mg and 25 mg reduced annualized exacerbation rates, prolonged the time to first exacerbation, and increased 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 reduced lung function decline and numerically improved Quality of Life-Bronchiectasis Respiratory Symptoms Domain score (QOL-B RSS) at week 52 vs placebo regardless of baseline blood eosinophil count.

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“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, M.D., MBA, Chief Medical Officer of 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.”

Additional Insmed Data at ATS

Insmed also presented a post-hoc analysis from ASPEN on lung function, health economics and outcomes research findings demonstrating the high burden of bronchiectasis on the healthcare system, as well as several other abstracts across the company’s portfolio. These showcased new findings from an expanded Phase 2 analysis for treprostinil palmitil inhalation powder (TPIP) in patients with pulmonary hypertension associated with interstitial lung disease (PH-ILD), including Functional Respiratory Imaging (FRI) data offering new insights into the impact of TPIP on lung structure and function. Also shared were real-world comparative outcomes for patients treated with ARIKAYCE (amikacin liposome inhalation suspension) and data exploring longitudinal health status improvements following culture conversion in refractory Mycobacterium avium complex (MAC) lung disease.

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Source – PR Newswire