Press release
Insmed Announces Positive Top-Line Results from Phase 2 WILLOW Study of INS1007 in Patients with Non-Cystic Fibrosis Bronchiectasis
-- Study Achieves Primary Endpoint with Statistically Significant Improvement in Time to First Exacerbation for Both Dosage Strengths of INS1007 Versus
About this update from Insmed Incorporated
[{"type":"text","content":"-- Study Achieves Primary Endpoint with Statistically Significant Improvement in Time to First Exacerbation for Both Dosage Strengths of INS1007 Versus Placebo --\n -- Treatment with INS1007 also Achieves Key Secondary Endpoint of Reduction of Frequency of Pulmonary Exacerbation --\n -- INS1007 Was Generally Well-Tolerated at Both Dosage Strengths --\n -- Company Plans to Advance INS1007 to Phase 3 Development --\n\n\nBRIDGEWATER, N.J., Feb. 3, 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 positive top-line results from its global, randomized, double-blind placebo-controlled Phase 2 WILLOW study evaluating the efficacy, safety, and pharmacokinetics of INS1007 administered once daily in adults with non-cystic fibrosis bronchiectasis (NCFBE). INS1007 is a novel, oral, selective, reversible inhibitor of dipeptidyl peptidase 1 (DPP1). \nThe WILLOW study met its primary endpoint of time to first pulmonary exacerbation over the 24-week treatment period for both the 10 mg and 25 mg dosage groups of INS1007 compared to placebo (p=0.027, p=0.044, respectively). In addition, treatment with INS1007 resulted in a reduction in the frequency of pulmonary exacerbations, a key secondary endpoint, versus placebo. Specifically, patients treated with INS1007 experienced a 36% reduction in the 10 mg arm (p=0.041) and a 25% reduction in the 25 mg arm (p=0.167) versus placebo. Change in concentration of active neutrophil elastase (NE) in sputum versus placebo from baseline to the end of the treatment period was also statistically significant (p=0.034 for 10 mg, p=0.021 for 25 mg). \n\"These results are incredibly encouraging and highlight the potentially important role INS1007 may play in the management of bronchiectasis,\" said lead study investigator James Chalmers, MBChB, Ph.D., Professor and Consultant Respiratory Physician at the School of Medicine, University of Dundee, UK. \"Today, many bronchiectasis patients suffer from persistent symptoms and frequent exacerbations, with no pharmaceutical therapies available that are approved to help them manage this disease. There is an urgent need for approved, effective therapies that can break the vicious cycle of inflammation, lung damage, and infection for these ...