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Insmed Incorporated Message Board

  • cvarg4 cvarg4 Apr 26, 2014 3:43 PM Flag

    UPDATE: Insmed Says Arikayce Did Not Meet Pre-Specified Level for Statistical Significance

    Insmed Incorporated today reported results from the Company's phase 2 clinical trial of ARIKAYCE^TM, or liposomal amikacin for inhalation, for the treatment of patients with treatment resistant

    nontuberculous mycobacterial (NTM) lung infections. The randomized, double-blind, placebo-controlled phase 2 clinical trial compared ARIKAYCE (590 mg delivered once daily), added to standard of care treatment, versus standard of care treatment

    plus placebo, in 90 adult patients with treatment resistant NTM lung disease. Eligibility for the study required patients to have been on the American Thoracic Society/Infectious Disease Society of America (ATS/IDSA) guideline therapy for at least

    six months prior to screening and to continue to have persistently positive mycobacterial cultures.

    The primary efficacy endpoint of the study was a semi-quantitative measurement of the change in mycobacterial density on a seven-point scale from baseline (day one) to the end of the randomized portion of the trial (day 84). ARIKAYCE did not meet the pre-specified level for statistical significance

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