Insmed Inc. (INSM) has revealed promising subgroup data from the Phase 3 ASPEN study at the CHEST 2024 Annual Meeting in Boston. This global, randomized, double-blind, placebo-controlled study focused on evaluating the efficacy, safety, and tolerability of brensocatib for individuals with non-cystic fibrosis bronchiectasis.
The recent analyses highlight a consistent positive effect on reducing exacerbation rates across most predefined subgroups. Notably, brensocatib at a 25 mg dosage demonstrated an ability to slow the decline in lung function, as measured by FEV1, across all such subgroups. This reinforces the potential comprehensive benefit of brensocatib for a wide range of patients should it receive approval.
The company emphasized that the annual rate of pulmonary exacerbations showed a preference for brensocatib at both 10 mg and 25 mg dosages compared to the placebo in nearly all subgroups. Additionally, a separate analysis indicated that the least squares mean difference for the 25 mg dosage resulted in a lesser decline in post-bronchodilator FEV1 at Week 52 compared to the placebo across all predefined subgroups. The outcomes for those receiving the 10 mg dosage paralleled the overall study population results.
Insmed intends to submit a New Drug Application to the U.S. Food and Drug Administration for brensocatib, targeting patients with bronchiectasis, in the fourth quarter of 2024. Subject to regulatory clearance, the company aims to launch brensocatib in the U.S. by mid-2025, followed by its introduction to the European and Japanese markets in the first half of 2026.