Insmed Incorporated (NASDAQ: INSM) has announced additional positive results from the Aspen study, a global phase 3 study assessing the efficacy, safety, and tolerability of brensocatib in patients with non-cystic fibrosis bronchiectasis.
The study revealed that both dosage strengths of brensocatib achieved statistical and clinical significance for the reduction in the annualized rate of pulmonary exacerbations (PEs) versus placebo over the 52-week treatment period. The annualized rate of exacerbations was 1.015 for the brensocatib 10 mg group, 1.036 for the brensocatib 25 mg group, and 1.286 for placebo.
Patients treated with brensocatib 25 mg showed significantly less decline in post-bronchodilator forced expiratory volume over one second (FEV1) at week 52, preserving more lung function compared to placebo (ls mean change of 38 ml, p=0.0054). In addition, patients in the brensocatib 25 mg group also demonstrated nominally significantly less decline in post-bronchodilator forced vital capacity (FVC) compared to placebo (ls mean change of 75 ml, p<0.0001).
Moreover, both dosage groups of brensocatib experienced numerical improvements in the quality of life-bronchiectasis (QOL-B) respiratory symptom domain score, with the brensocatib 25 mg dose group demonstrating a nominally significant improvement of 3.8 points versus placebo (p=0.0004).
The safety profile of brensocatib was favorable, with treatment-emergent adverse events (TEAEs) occurring in at least 5.0% of patients treated with either dose of brensocatib and more frequently than in placebo being COVID-19, nasopharyngitis, cough, and headache.
Insmed intends 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, with an anticipated U.S. launch in mid-2025 followed by launches in Europe and Japan in the first half of 2026.
The Aspen study engaged over 460 trial sites in nearly 40 countries, with the primary efficacy analysis including data from 1,680 adult patients and 41 adolescent patients.
Bronchiectasis affects approximately 500,000 patients in the U.S., 600,000 patients in Europe, and 150,000 patients in Japan, and there are currently no approved therapies specifically targeting bronchiectasis in these regions.
Brensocatib is a small molecule, oral, reversible inhibitor of dipeptidyl peptidase 1 (DPP1) being developed by Insmed for the treatment of patients with bronchiectasis, CRSSNP, and other neutrophil-mediated diseases.
Insmed is a global biopharmaceutical company on a mission to transform the lives of patients with serious and rare diseases, with its first commercial product being a first-in-disease therapy approved in the United States, Europe, and Japan to treat a chronic, debilitating lung disease. Today the company's shares have moved -3.9% to a price of $62.0. If you want to know more, read the company's complete 8-K report here.
