Insmed : Phase 3 Analyses Of Brensocatib In Bronchiectasis Align With Positive Overall Trial Results

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(RTTNews) - Insmed Inc. (INSM) said it 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.

The new sub-analyses showed a consistent positive impact on the rate of exacerbations across the majority of prespecified subgroups. 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, the company said.

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 company noted that 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.

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.

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