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Insmed Announces Positive Topline Results from Phase 3b ENCORE Study of ARIKAYCE® (Amikacin Liposome Inhalation Suspension) in Patients with MAC Lung Disease
—The Study Met Primary and All Multiplicity-Controlled Secondary Culture Conversion Endpoints, Demonstrating Statistically Significant and Clinically
About this update from Insmed Incorporated
[{"type":"text","content":"—The Study Met Primary and All Multiplicity-Controlled Secondary Culture Conversion Endpoints, Demonstrating Statistically Significant and Clinically Meaningful Improvements in Respiratory Symptom Score and Culture Conversion Rates——In the Second Half of 2026, Insmed Plans to File a Supplemental NDA for ARIKAYCE with the FDA and Submit the Data to the PMDA in Japan to Support Potential Label Changes——Insmed to Host Investor Conference Call on Monday, March 23, 2026, at 8:00 AM ET—BRIDGEWATER, N.J., March 23, 2026 /PRNewswire/ -- Insmed Incorporated (Nasdaq: INSM), a people-first global biopharmaceutical company striving to deliver first- and best-in-class therapies to transform the lives of patients facing serious diseases, today announced positive topline results from the Phase 3b ENCORE study. This study evaluated ARIKAYCE® (amikacin liposome inhalation suspension) plus multidrug therapy (azithromycin 250 mg + ethambutol 15 mg/kg) once-daily versus placebo plus multidrug therapy once-daily in diagnosed patients with a new occurrence of Mycobacterium avium complex (MAC) lung infection who had not received antibiotics.Topline efficacy results from the ENCORE study are as follows:ARIKAYCE 590 mg plusazithromycin 250 mg +ethambutol 15 mg/kg(N=213)Placebo plus azithromycin 250 mg + ethambutol 15 mg/kg (N=212)Treatmentdifference,p-valuePrimary EndpointChange from Baseline in Respiratory Symptom Score at Month 1317.77 points14.66 points3.11 points,p=0.0299*Multiplicity-Controlled Secondary EndpointsCulture Conversion byMonth 687.8 %57.0 %30.8%,p","length":7743,"tagName":"div"}]