Q: Has ACHN disclosed how many cohorts the phase-1b portion of the trial will have?
That's a good question and one I was thinking about earlier today. I went back to the slides from the Lazard conference in November and slide 14 appears to suggest that there are two cohorts of 9 patients each in the Phase 1b. See: http://www.wsw.com/webcast/lz6/achn/
As previously noted, though, management indicated at this conference that there was a possibility that they could add another cohort (so, I assume 3 total is possible).
Do you see any concern that this first cohort was a BID cohort? Or perhaps a better question is would you consider it bearish if ACHN only utilizes BID dosing in these Phase 1b cohorts? I would think ACHN would want to try QD dosing in one of these cohorts, as that is supposed to be a potential advantage of ACH-1625 compared to telaprevir. The other thought is perhaps it's too early to try the QD dose and that they want to do BID to start just to ensure that they get enough potency and are able to show a max log drop in HCV. They can always try the QD dose later once they've at least shown initial PoC with ACH-1625 in these Phase 1b trials.
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