Insmed(US:INSM) prnewswire.comยท2024-05-28 10:30Core Insights - Insmed announced positive topline results from the Phase 3 ASPEN study for brensocatib, showing significant reduction in pulmonary exacerbations compared to placebo [1][2] - The study met its primary endpoint and several secondary endpoints, indicating brensocatib's potential as a new treatment for bronchiectasis [1][3] - Insmed plans to file a New Drug Application (NDA) with the FDA in Q4 2024, with a potential U.S. launch in mid-2025 [2][4] Study Results - Brensocatib 10 mg showed a 21.1% reduction in annualized rate of pulmonary exacerbations (PEs) (p=0.0019) and 25.8% reduction in severe PEs [3] - Brensocatib 25 mg demonstrated a 19.4% reduction in annualized rate of PEs (p=0.0046) and 26.0% reduction in severe PEs [3] - Secondary endpoints included an 18.7% prolongation of time to first PE for 10 mg (p=0.0100) and 17.5% for 25 mg (p=0.0182) [3] Safety and Tolerability - Brensocatib was well-tolerated, with treatment-emergent adverse events (TEAEs) occurring in 77.7% of patients on 10 mg and 76.7% on 25 mg, compared to 79.6% in placebo [5] - Serious TEAEs were reported in 17.4% for 10 mg and 16.9% for 25 mg, versus 19.2% in placebo [5] - The most common TEAEs included COVID-19, nasopharyngitis, cough, and headache [5] Regulatory and Market Outlook - If approved, brensocatib would be the first treatment for bronchiectasis and the first DPP1 inhibitor [2][11] - Insmed anticipates launches in Europe and Japan in the first half of 2026 following the U.S. launch [2] - Approximately 1 million bronchiectasis patients in the U.S. may benefit from an approved treatment [5] Company Background - Insmed is focused on developing therapies for serious and rare diseases, with a robust pipeline targeting neutrophil-mediated inflammatory diseases [12] - The company has received Breakthrough Therapy Designation from the FDA and access to the PRIME scheme by the European Medicines Agency for brensocatib [5][12]