Biopharmaceutical company Insmed Incorporated (Nasdaq: INSM) announced on Wednesday that additional positive results from the ASPEN study of brensocatib in patients with bronchiectasis will be presented at the 7th World Bronchiectasis Conference in Dundee, Scotland, on 4 July 2024.

The ASPEN study, a Phase 3 trial, demonstrated significant reductions in annual pulmonary exacerbations and preserved lung function in patients treated with brensocatib compared to placebo over 52 weeks.

Key findings include a 21.1% and 19.4% risk reduction in exacerbations for the 10 mg and 25 mg brensocatib groups, respectively, compared to placebo. Brensocatib 25 mg also showed significantly less decline in lung function, as measured by FEV1 and FVC, and improvements in patient-reported quality of life scores.

Insmed plans to submit a New Drug Application for brensocatib to the FDA in Q4 2024, with potential launches in the US, Europe and Japan anticipated by mid-2025 to early 2026, pending regulatory approvals. Brensocatib, if approved, would be the first treatment specifically for bronchiectasis, targeting neutrophil-mediated diseases with its unique DPP1 inhibitor mechanism.

The ASPEN study enrolled over 1,700 patients across 391 sites in 35 countries, highlighting its global scope and comprehensive evaluation of brensocatib's efficacy and safety profile in treating this chronic lung condition.

Bronchiectasis is a serious, chronic lung disease that affects approximately 1.25 million patients in the US, Europe and Japan combined, underscoring the potential impact of brensocatib in addressing unmet medical needs in these regions.

Insmed, headquartered in Bridgewater, New Jersey, is committed to advancing innovative therapies for serious and rare diseases through its robust pipeline and global research efforts.