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Insmed Incorporated Message Board

  • thevacuousone thevacuousone Mar 21, 2014 10:18 AM Flag

    Why Arikayce Phase2 Study Will Be Successful?

    Insmed Incorporated (INSM): Why Arikayce Phase2 Study Will Be Successful?
    By: Mani
    March 21, 2014 08:00 AM
    Stocks: INSM,

    Within the next two weeks, Insmed Incorporated (NASDAQ:INSM) is expected to report top-line results from the phase2 trial of Arikayce in patients with lung infection from non-tuberculous mycobacteria (NTM), a type of bacteria that can cause severe lung disease.

    Given the significant unmet medical need, as well as the Fast Track and Qualified Infectious Disease Product (QIDP) designations granted by the FDA, the phase2 data could potentially be registration-enabling for Arikayce in NTM.

    The primary efficacy endpoint for this study is the change in mycobacterial density from baseline to the end of 84 days of treatment. The study will also measure several secondary endpoints, including the proportion of patients with culture conversion to negative, and the time to rescue anti-mycobacterial drugs.

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    UBS analyst Matthew Roden noted that culture clearance is the most compelling of the secondary endpoints. The data are expected in the last two weeks of March and will represent the 12-week endpoints from randomized portion of the trial. However, data from the 6-month endpoints will also be available.

    For the company, it will be a clear win if the reported data hit on the primary endpoint with statistical significance and hit on at least one secondary endpoint (preferably culture clearance).

    If Insmed is able to show significance on the primary and at least one secondary endpoint, then the overall dataset to carry more weight with regulators and lower risk to approval. Further, a stronger dataset implies better pricing power ahead of payer negotiations once the drug is approved.

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    Roden sees Arikayce as having a clear bactericidal effect on NTM in vitro and in vivo. Studies h

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