Insmed(INSM) Prnewswire·2025-04-23 21:00Core Insights - Insmed Incorporated announced positive results from the pivotal phase 3 ASPEN study of brensocatib, demonstrating a statistically significant reduction in pulmonary exacerbations in patients with non-cystic fibrosis bronchiectasis [1][2] - Brensocatib is currently under Priority Review with the U.S. FDA, with a target action date of August 12, 2025 [5] Study Results - The ASPEN study is the largest clinical trial ever conducted in bronchiectasis, involving 1,680 adult patients and 41 adolescent patients across 391 sites in 35 countries [6][7] - The annualized rate of pulmonary exacerbations was significantly lower in the brensocatib groups: 1.02 for 10 mg, 1.04 for 25 mg, compared to 1.29 for placebo, with rate ratios of 0.79 (P=0.004) and 0.81 (P=0.005) respectively [2][3] - Both dosage strengths of brensocatib also met secondary endpoints, including prolonging time to first exacerbation and increasing the proportion of patients remaining exacerbation-free [3] Safety and Tolerability - Brensocatib was well-tolerated, with treatment-emergent adverse events (TEAEs) occurring in at least 5% of patients, including COVID-19, nasopharyngitis, cough, and headache [4] Market Potential - Approximately 500,000 patients in the U.S., 600,000 in the EU5, and 150,000 in Japan are diagnosed with bronchiectasis, highlighting a significant unmet medical need [7] - Brensocatib has the potential to be the first approved therapy for bronchiectasis and the first DPP1 inhibitor, addressing a range of neutrophil-mediated inflammatory diseases [5][8] Company Overview - Insmed is a global biopharmaceutical company focused on delivering first- and best-in-class therapies for serious diseases, with a diverse portfolio of investigational medicines [9][10]