Insmed Announces Initiation of Phase 3 ASPEN Study of Brensocatib in Patients with Bronchiectasis

IndustryPRwire -- Insmed Incorporated announced that the first patient has been dosed in the Phase 3 ASPEN study of brensocatib in patients with bronchiectasis. Brensocatib is a novel, first-in-class, oral, reversible inhibitor of dipeptidyl peptidase 1 (DPP1) being developed by Insmed for the treatment of bronchiectasis and other inflammatory diseases.

Martina Flammer, M.D., MBA, Chief Medical Officer of Insmed Commented "There is an urgent need for an approved therapy for the treatment of bronchiectasis that has the potential to reduce exacerbations—the major driver of morbidity and mortality in these patients, Building on the strength of data from our Phase 2 WILLOW study, which showed that treatment with brensocatib both prolonged the time to first exacerbation and reduced the risk of exacerbation over the 24-week treatment period, we are very pleased to initiate the registrational ASPEN trial. We believe this is a significant step toward enabling regulatory submissions and potentially bringing brensocatib to patients in need."  

ASPEN is a global, randomized, double-blind, placebo-controlled Phase 3 study to assess the efficacy, safety, and tolerability of brensocatib in patients with bronchiectasis. Patients with bronchiectasis due to cystic fibrosis may not be enrolled in the study. Patients will be randomized to receive brensocatib 10 mg, brensocatib 25 mg, or placebo once daily for 52 weeks. The primary endpoint is the rate of pulmonary exacerbations over the 52-week treatment period. Secondary endpoints include time to first pulmonary exacerbation, percentage of subjects who remain pulmonary exacerbation-free, change from baseline in post-bronchodilator FEV1, rate of severe pulmonary exacerbations, change from baseline in the Bronchiectasis (QOL-B) Respiratory Symptoms Domain Score, and incidence and severity of treatment-emergent adverse events.

The study is expected to enroll approximately 1,620 patients (540 in each arm) at approximately 480 sites in 40 countries. More information on this study is available at (NCT04594369).

Brensocatib has received Breakthrough Therapy Designation from the U.S. Food and Drug Administration as well as Priority Medicines (PRIME) designation from the European Medicines agency for patients with bronchiectasis.

About Brensocatib

Brensocatib is a small molecule, oral, reversible inhibitor of dipeptidyl peptidase 1 (DPP1) being developed by Insmed for the treatment of patients with bronchiectasis and other neutrophil-mediated diseases. DPP1 is an enzyme responsible for activating neutrophil serine proteases (NSPs), such as neutrophil elastase, in neutrophils when they are formed in the bone marrow. Neutrophils are the most common type of white blood cell and play an essential role in pathogen destruction and inflammatory mediation. In chronic inflammatory lung diseases, neutrophils accumulate in the airways and result in excessive active NSPs that cause lung destruction and inflammation. Brensocatib may decrease the damaging effects of inflammatory diseases such as bronchiectasis by inhibiting DPP1 and its activation of NSPs.

About Bronchiectasis

Bronchiectasis is a severe, chronic pulmonary disorder in which the bronchi become permanently dilated due to a cycle of infection, inflammation, and lung tissue damage. The condition is marked by frequent pulmonary exacerbations requiring antibiotic therapy and/or hospitalizations. Symptoms include chronic cough, excessive sputum production, shortness of breath, and repeated respiratory infections, which can worsen the underlying condition. Bronchiectasis affects approximately 340,000 to 520,000 patients in the U.S. Today, there are no approved therapies specifically targeting bronchiectasis in the U.S., Europe, or Japan.

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