Replies to post #480 on Idenix Pharmaceuticals (IDIX)

[gofishmarko]

I think the implication is that the only way they can get to P3 is with triple therapy , and that IDIX might decide to go to the P3 based on the outcome of the current study alone.

I've been wondering why we've never heard anything about SVR rates from past studies of NM283. Now we know -- there weren't any.

If IDIX wants to do a dose-optimizing P2 triple therapy study they better do it pronto. They're going to wake up one morning to find VX950 the new SOC , with the higher approval hurdle that goes along with it. If things are as gloomy as PJ suggests , I bet IDIX will give serious consideration to waiting for VX950 approval , then run the combo polymerase-protease trials that everyone is expecting.

Bummer.

[go seek]

PEG and NM283 @ 48 weeks was already shown to have a significantly higher SVR than SoC... this reported @ AASLD in October.

I do not understand PJ report... the hope is add RBV and attain better SVR than PEG and NM283 alone

what am i missing?

[DewDiligence]

I’ve distributed the PJ report on IDIX to everyone who is signed up on this board for email distribution.

I have two main objections to the report:

1. It’s too soon for PJ (or anyone else) to have more than a token amount of SVR data from the NM283 trial in the treatment-naive setting. The reasoning is laid out in #msg-17335706.

Thus, I find it disingenuous when Rachel McMinn says that relapses are running at 100% according to one of her sources. This 100% figure might be 2 patients out of 2! Without giving the value of n, such an assertion seems designed to alarm rather than inform.

2. The “UND” (PCR-negative) numbers in the third row of the tables for each of McMinn’s four scenarios on page 2-3 are way off, IMO. This is especially true in scenario #3, which she describes as the scenario with no interaction (0% antagonism between NM283 and ribavirin). In this scenario, it makes no sense whatever for the UND values to be lower for triple therapy than for SoC, yet that is what her numbers show at the 12-week time point.

Dew