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BRIEF-Insmed announces positive top-line results from phase 3 convert study of ALIS
September 5, 2017 / 11:30 AM / 16 days ago

BRIEF-Insmed announces positive top-line results from phase 3 convert study of ALIS

Sept 5 (Reuters) - Insmed Inc

* Insmed announces positive top-line results from phase 3 convert study of ALIS (amikacin liposome inhalation suspension) in adult patients with treatment-refractory nontuberculous mycobacterial (NTM) lung disease caused by mycobacterium avium complex (MAC)

* Study met primary endpoint of culture conversion (p< 0.0001)​

* Positive top-line results from global phase 3 controlled study in patients with NTM, a rare, progressive, destructive lung infection​

* Company plans to pursue accelerated approval and request priority review​

* Plans to pursue accelerated approval of ALIS under subpart H based on data from convert study, which will be reviewed by division of anti-infective products​

* Company also reported top-line data for several secondary endpoints as of 6-month timepoint​

* Top-line data for 6-minute walk test indicates no statistically significant difference between patients in two arms​

* Company is continuing its analysis of impact of conversion on a variety of other clinical measures​ Source text for Eikon: Further company coverage:

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