Replies to post #81779 on Biotech Values

[mcbio]

Re: VRUS PSI-7851 data

Preliminary Antiviral Response Observed Following PSI-7851 Administered as Monotherapy for 3 Days
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Dose N Mean Change in HCV RNA at Day 3
(Log(10))
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50mg QD 8 -0.49
100mg QD 8 -0.61
200mg QD 8 -1.01
Placebo 6 -0.03
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I totally missed this release on Friday given that it was at 7am. Thanks for posting.

So, if we compare the 100mg qd dose to that of IDX-184, IDX-184 was actually more potent, given a -0.74 mean decrease vs. a -0.61 mean decrease for PSI-7851. I think the bottom line is that IDIX needs to consider a 200mg qd dose in the next trial.

[mcbio]

VRUS - Notes on PSI-7851 conference call

I just listened to this call and have a few notes, as follows:

1. R7128 (the 1st gen nuke) is now known as RG7128.

2. There were apparently no AEs seen in the Phase 1 trial for PSI-7851 (2nd gen nuke) and nothing at all to prevent them from increasing the dose for PSI-7851 above the 200mg qd dose in future trials. Notwithstanding, it was a little unclear to me if they actually do intend to increase the dose as management inferred that the efficacy was good enough at the 200mg qd dose (i.e., the log drops seen in the 200mg qd dose is similar to what was seen in the RG7128 28-day study that led to RVRs of 88%).

3. It takes PSI-7851 about a week to reach steady state.

4. The DSMB readout on the first 100 patients in the current Phase 2b for RG7128 is expected to take place in 4Q09.

5. VRUS expects to file an IND for PSI-938 (3rd gen nuke) in 1Q10.

All told, I am eagerly awaiting the DSMB readout on the first 100 patients in the ongoing Phase 2b for RG7128. If there is any type of safety issue seen in these patients causing a material drop in share price, I will be quite interested in VRUS given what is going on with the 2nd and 3rd gen nukes.