Replies to post #98409 on Biotech Values

[DewDiligence]

What about Phase 1b results for IDX-320? We haven't heard anything from the company.

The phase-1b monotherapy trial of IDX320 started four weeks ago (#msg-51127676). I don’t have an entry in the 2010-2011 News Flow post for the reporting of data from this trial because I haven’t heard IDIX say when they plan to disclose the results. My guess is that IDIX will not disclose these results until they have met with the FDA to determine whether they can proceed to an all-oral phase-2a trial of IDX184+IDX320 in HCV patients. Hence, the material news-flow item will be the go-ahead from the FDA to start the phase-2a combination trial, and the reporting of data from the phase-1b IDX320 study will not be especially consequential in its own right.

…looks like maximum [IDX320] effect is seen with 400 mg dose IMO. My guess is based on dose selection for DDI study.

400mg is the highest IDX320 dose to be tested in the phase-1b trial, so it makes sense that IDIX is using this dose in the DDI study. However, I don’t think we can assume that 400mg will be the highest (or only) IDX320 dose to be tested in the phase-2a combination trial in HCV patients; we can assume that the IDX320 doses tested in that trial will not be higher than 400mg, but they might be smaller, depending on the PK/PD data from the DDI study.