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ARTICLE | Clinical News

Insmed's ALIS meets in Phase III for rare lung infection

September 8, 2017 4:15 PM UTC

Insmed Inc. (NASDAQ:INSM) reported top-line data from the Phase III CONVERT trial in 336 patients with treatment-refractory non-tuberculosis mycobacterial (NTM) lung infection caused by Mycobacterium avium complex (MAC) showing that ALIS (amikacin liposome inhalation suspension, Arikayce) met the primary endpoint of culture conversion with no relapse or recurrence by month 6. Specifically, once-daily ALIS plus guideline-based therapy (GBT) eliminated evidence of NTM lung disease caused by MAC in sputum in 29% of patients by month 6 vs. 9% of patients who received GBT alone (p<0.0001). The trial enrolled patients who were refractory to at least 6 months of GBT to receive ALIS plus GBT or continue receiving GBT alone.

ALIS plus GBT also met the secondary endpoint of reducing time to conversion (reduction of 23.1% vs. GBT alone, p<0.0001), but missed the secondary endpoint of improving 6-minute walk distance (6MWD) vs. GBT alone. The GBT used in the open-label, international trial was based on guidelines from the Infectious Diseases Society of America and the American Thoracic Society. Patients who did not achieve culture conversion in CONVERT have the option of enrolling in the company's open-label INS-312 trial to receive ALIS plus GBT for 12 months. ALIS is inhaled liposomal amikacin administered with the eFlow Nebulizer System from Pari GmbH (Starnberg, Germany)...

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