Replies to post #103613 on Biotech Values

[DewDiligence]

Linear pharmacokinetics is necessary but not sufficient for ruling out a drug-drug interaction. This is especially true when one of the drugs in the combination is a compound like IDX184 that undergoes multiple transformations to be converted into the active (triphosphate) metabolite.

We discussed this topic in detail a couple months back. McBio raised the subject if you recall.

I recall the thread well; it does not appear to be directly related to the SAE’s seen in the DDI study.

I’m not entirely sure what you’re driving at, so perhaps you should spell it out. Why do you think the DDI study showed three SAE’s when the prior separate studies of IDX184 and IDX320 in animals and humans did not?

[mcbio]

Re: IDX320 safety issues

Perhaps clean wasn't the right choice of words. Your quote above is what I was referring to. The DDI study does not conclusively indicate the cause of the three SAE's is through combination. Idenix hasn't even delivered the POC study results for IDX320 to the FDA. Would you like to comment on the AE discussed in the c.c.?

Are you saying that IDIX disclosed an AE with respect to the IDX320 monotherapy Phase 1 during today's call? I am trying to clarify if you are talking about today's call (which again, I haven't listened to yet) or if you are saying this 320 AE was disclosed during a prior call. I definitely don't recall any prior discussion of an AE regarding 320. If this news was in fact disclosed during today's call then perhaps it's reasonable to infer that 320 is the culprit behind the AEs in the 184/320 DDI study. I actually think this would be good news for IDIX as this would remove some of the uncertainty and they could continue to push forward in partnering 184. 320 was early stage anyways and can presumably be replaced by the NS5A inhibitor. To be clear, the news today was not good, but it's better if IDIX has an inkling that 320 may be the culprit behind the safety issues.