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Vertex Pharmaceuticals Incorporated Message Board

  • verityvoila verityvoila May 7, 2012 3:32 PM Flag

    Part II 809 Combo--Things to Ponder

    Some random thoughts from the entire call/info:

    1. Vertex said it had no intent of doing 809 mono, but that no stat. sign. improvement in combo portion and that the FEV improvement was "maintained". Vertex refused to say when FEV improvement started. . . . just wondering HOW it could possibly be the "combo" and not 809 that is moving the improvement.
    2. Heard that 809 reduces effectiveness of 770. I'll pull that later and post, but if that is true, think what this means for 661 (which isn't suppose to have the same issue with 770).
    3. Struggling with how to get my arms around SC not improving much different than Phase 2a.
    4. Curious how FDA is going to handle SC for other studies if it doesn't predict improvement in FEV?
    5. How quick can "accelerated" be?
    6. Likely nothing new until Oct. conference UNLESS 661 causes need for disclosure for acceleration.
    7. Remember: 5% improvement will justify FDA approval.

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    • does anyone have info on neg 770 and 809 interaction. I had read 809 neg affected 770 ...but cannot find where I read now. But makes me even more up on 661.

      • 1 Reply to verityvoila
      • Okay, I found the quote that was giving the "reason" behind why 809 at higher doses was reducing the effectiveness of 770. Any thoughts on this/better sources? Again, this problem is not suppose to exist with 661, . . . so imagine the results on that!!!

        "I have read blogs, where it is speculated that it is an issue of lipoabsorption where VX-770 and VX-809 compete... (both of them are lipophilic). This issue may be more or less relevant depending on the person. VX-661 should not have this problem because it is idrophilic."

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