Press release
Insmed Announces Initiation of Phase 3 ASPEN Study of Brensocatib in Patients with Bronchiectasis
--First Patient Dosed in Global, Registrational Study of First-in-Class Treatment Candidate-- BRIDGEWATER, N.J., Dec. 2, 2020 /PRNewswire/ -- Insmed
About this update from Insmed Incorporated
[{"type":"text","content":"--First Patient Dosed in Global, Registrational Study of First-in-Class Treatment Candidate--\n\n\nBRIDGEWATER, N.J., Dec. 2, 2020 /PRNewswire/ -- Insmed Incorporated (Nasdaq:INSM), a global biopharmaceutical company on a mission to transform the lives of patients with serious and rare diseases, today 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.\n\"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,\" said Martina Flammer, M.D., MBA, Chief Medical Officer of Insmed. \"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.\" \nASPEN 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. \nThe 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 clinicaltrials.gov (NCT04594369). \nBrens...