Insmed Announces Positive Topline Results from Phase 3 ASPEN Study of Brensocatib in Bronchiectasis

INSMED Inc

ASPEN Phase 3 met primary endpoint: brensocatib 10mg and 25mg reduced annualized pulmonary exacerbations by 21.1% (p=0.0019) and 19.4% (p=0.0046) vs placebo.
Brensocatib achieved statistical significance on multiple secondary endpoints including prolongation of time to first PE and odds of remaining exacerbation-free.
Insmed plans to file NDA with FDA in Q4 2024; anticipates U.S. launch mid-2025, Europe/Japan launches first half 2026.
If approved, brensocatib would be first approved treatment for bronchiectasis and first DPP1 inhibitor for neutrophil-mediated diseases.
Brensocatib well-tolerated; severe TEAEs occurred in 12.7% (10mg), 11.7% (25mg), and 16.0% (placebo) with lower serious TEAE rates than placebo.

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