New Subgroup Analyses from Landmark Phase 3 ASPEN Study of Brensocatib in Patients with Bronchiectasis Demonstrate Consistency with Positive Overall Trial Population Results

—Data Presented at the CHEST 2024 Annual Meeting—

BRIDGEWATER, N.J., Oct. 8, 2024 /PRNewswire/ -- Insmed Incorporated (Nasdaq: INSM), a people-first global biopharmaceutical company striving to deliver first- and best-in-class therapies to transform the lives of patients facing serious diseases, today presented positive late-breaking subgroup data from the Phase 3 ASPEN study, a global, randomized, double-blind, placebo-controlled Phase 3 study to assess the efficacy, safety, and tolerability of brensocatib in patients with non-cystic fibrosis bronchiectasis. Posters with the details from these subgroup analyses can be found HERE. These data were presented at the CHEST 2024 Annual Meeting, held October 6-9 in Boston, along with several other presentations from across Insmed's respiratory portfolio.

"The positive results from the landmark Phase 3 ASPEN study have generated tremendous excitement among physicians and patients alike, providing hope for a much-needed approved treatment for bronchiectasis. Given the heterogeneity of this disease, it is striking that these new sub-analyses show a consistent positive impact on the rate of exacerbations across the majority of prespecified subgroups," said lead study investigator James Chalmers, MBChB, Ph.D., Professor and Consultant Respiratory Physician at the School of Medicine, University of Dundee, UK. "It is particularly exciting to see that, consistent with the overall trial analysis, brensocatib 25 mg was able to slow lung function decline as measured by FEV1 for all prespecified subgroups, further underscoring the potential impact this investigational treatment candidate may have on a diverse range of patients if approved."

Consistent with positive results for the overall ASPEN population, the annualized rate of pulmonary exacerbations favored brensocatib at both the 10 mg and 25 mg doses over placebo for almost all subgroups. In a separate analysis, least squares mean difference for brensocatib 25 mg demonstrated a reduced decline in post-bronchodilator FEV1 at Week 52 versus placebo for all prespecified subgroups. Results for patients treated with brensocatib 10 mg among subgroups were aligned with the overall trial population results.

Brensocatib was well-tolerated in the study. Treatment-emergent adverse events (TEAEs) occurring in at least 5.0% of patients treated with either dose of brensocatib and more frequently than in placebo were COVID-19 (15.8%, 20.9%, 15.8%), nasopharyngitis (7.7%, 6.3%, 7.6%), cough (7.0%, 6.1%, 6.4%), and headache (6.7%, 8.5%, and 6.9%) for brensocatib 10 mg, brensocatib 25 mg, and placebo, respectively.

"We are incredibly excited to present subgroup findings from the ASPEN study at CHEST 2024, building on the positive results we have already shared with the bronchiectasis community," said Martina Flammer, M.D., MBA, Chief Medical Officer of Insmed. "The consistency of efficacy observed across most subgroups, particularly at the higher dose, further supports our belief that brensocatib has the potential to transform the treatment landscape for patients with bronchiectasis. We eagerly look forward to filing a new drug application for brensocatib in the U.S., followed by Europe and Japan, in hopes of delivering the first approved therapy for patients affected by this serious and difficult-to-treat disease."

Insmed plans to file a New Drug Application with the U.S. Food and Drug Administration for brensocatib in patients with bronchiectasis in the fourth quarter of 2024. Pending regulatory approvals, Insmed anticipates a U.S. launch for brensocatib in mid-2025 followed by launches in Europe and Japan in the first half of 2026. If approved, brensocatib would be the first approved treatment for patients with bronchiectasis as well as the first approved dipeptidyl peptidase 1 (DPP1) inhibitor—a new mechanism of action with the potential to address a range of neutrophil-mediated diseases.

About ASPENAs part of the ASPEN study's conduct, more than 460 trial sites were engaged in nearly 40 countries. After excluding sites that did not enroll any patients and all sites in Ukraine, the total number of active sites in ASPEN was 391 sites in 35 countries. Adult patients (ages 18 to 85 years) were randomized 1:1:1 and adolescent patients (ages 12 to