Replies to post #103678 on Biotech Values

[oc631]

No problem—I think oc631 did also, judging from his posts.

Dew

but two of the three SAE’s cannot be explained by any hypothesis other than an intracellular drug-drug interaction between IDX184 and IDX320.

Do you mean the post where I pointed out to you that IDX320 is just as liable to be the problem?

[mcbio]

Re: IDIX 184/320 DDI study

Dew, I want to revisit the 184/320 DDI study again briefly after thinking about this some more as I don't recall a lot of discussion in the prior threads about the 400mg QD dose of 320 that was used in the DDI study. Given the potency of the 100mg QD dose of 320 in the 3-day PoC study, which probably showed that a 100mg QD dose of 320 is plenty potent enough (I believe 3.1 log drop after 3 days) as part of an HCV DAA combo, do you see any chance that IDIX can convince the FDA of allowing it to move forward in testing 320, either alone or even with 184, at a much smaller dose like 100mg QD? Presumably fleshing out whether there is a signal from a much lower dose of 320 in combo with 184 will be a focus of the animal toxicology studies.