Insmed Incorporated ( INSM ) shares are trading higher after the company released topline results from the ASPEN Phase 3 study of brensocatib in patients with non-cystic fibrosis bronchiectasis.

Non–cystic fibrosis bronchiectasis is a chronic inflammatory condition of the lungs associated with respiratory infections, daily coughing, and sputum. 

The study met its primary endpoint, with both dosage strengths of brensocatib demonstrating statistically significant reductions in the annualized rate of pulmonary exacerbations (PEs) versus placebo. 

Brensocatib reduced pulmonary exacerbations by 21.1% at 10 mg dose versus placebo and 19.4% in the 25 mg cohort. 

The study also met several of its prespecified secondary endpoints with statistical significance.

At 10 mg and 25 mg, respectively, the annualized rate of severe PEs was reduced by 25.8% and 26%.

Prolongation of time to first PE: 18.7% and 17.5%.

Increase in odds of remaining exacerbation-free over 52 weeks: 41.2% and 40%.

The primary efficacy analysis included data from 1,680 adult patients and 41 adolescent patients.

Insmed ( INSM ) plans to file a New Drug Application with the FDA for brensocatib in patients with bronchiectasis in the fourth quarter of 2024. 

Pending regulatory approvals, Insmed ( INSM ) anticipates a U.S. launch for brensocatib in mid-2025, followed by launches in Europe and Japan in the first half of 2026. 

If approved, brensocatib would be the first approved treatment for patients with bronchiectasis and the first approved dipeptidyl peptidase 1 (DPP1) inhibitor.

Insmed ( INSM ) is also advancing the development of brensocatib in other neutrophil-driven inflammatory diseases. 

A Phase 2 study in patients with chronic rhinosinusitis without nasal polyps is currently underway, and Insmed ( INSM ) plans to initiate a Phase 2 study in hidradenitis suppurativa in the second half of 2024.

Price Action: At the last check Tuesday, INSM shares were up 135% at $51.70 during the premarket session.