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Insmed Incorporated Message Board

  • fudfighter4 fudfighter4 May 26, 2013 6:45 PM Flag

    Imminent clue to Phase III efficacy?

    From the description of the Arikace follow-on long term safety study -

    [Eligible subjects will receive 560 mg Arikace™ once daily via a PARI Investigational eFlow® Nebulizer for 28 days followed by a 28 day off treatment period. This cycle (28 days on-treatment, 28 days off-treatment) will be repeated for up to twelve cycles. The study will be implemented as two consecutive extension periods, each consisting of 48 weeks ...

    During the first 28 days of treatment, subjects will be evaluated at the clinic bi-weekly for safety, tolerability and efficacy. Thereafter, for the duration of the study, subjects will be evaluated at the clinic on the first and last days of dosing during the on-treatment periods. A final site visit will occur 28 days after last dose of Arikace™.]

    The participants who became eligible for the safety study, by virtue of their participation in the EU Phase III clinical trial from which results are expected mid-year, will have known whether they were taking Arikace or the comparator drug Tobi.

    The two nebulisation-inhalation systems are not at all similar - and it's likely that an individual with a history of chronic infection with Pseudomonas aeruginosa would previously have used Tobi.

    If the participants who were taking Arikace were impressed, one would imagine that throughout the course of the study word will have been filtering across to the participants on Tobi, and that a high proportion of both the approx 150 on Tobi and the approx 150 on Arikace will have volunteered for the safety study.

    If Arikace has been less than impressive, one would imagine that a large proportion of the approx 300 participants will have declined the follow-on study (and the associated visits to the clinic for tests) in favour of resuming their previous routines.

    continued ...

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    • Continuation ...

      From the Seeking Alpha transcript of the May 7 call -

      [Joseph Schwartz - Leerink Swann

      Good morning. I was wondering if you could give us any more insight into the proportion of patients that you see transitioning from the randomized control portion of CLEAR-108 into the extension study.

      Will Lewis

      Yes. Good morning, Joe. Thanks for the question. Actually, this is going to be one of those frustrating calls this morning because we have data that is just around the corner. We just are not going to be in the position to disclose it until it's finalized.

      With respect to this particular issue of carryover, while we had last patient, last visit yesterday, we would like to see the final definitive number so we can just come out and state it. And I anticipate that we would do that in the not-too-distant future by way of some form of disclosure, perhaps at the UBS Conference, if we know it by then.]

      The UBS conference was last week. I didn't listen in, but I'm sure the carryover figure would have been posted here had Lewis disclosed it.

      PR next week?

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