Upcoming Pharmasset announcement

[Juttutin]

I picked this up of a newsfeed:

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PRINCETON, N.J., March 28, 2011 /PRNewswire/ -- Pharmasset, Inc. (Nasdaq:  VRUS) today announced that it will webcast an investor event from the European Association for the Study of the Liver (EASL) on Saturday, April 2, 2011 starting at 8:00pm CET. During this webcast, management will review Pharmasset's progress on the programs that are the subject of presentations at EASL.

To access a simultaneous webcast of this event via the internet, log on to the "Events & Presentations" section of the Investor Center on Pharmasset's website at http://investor.pharmasset.com/events.cfm. Please connect to the website at least ten minutes prior to the start of the presentation to ensure adequate time for a reliable connection and any software download that may be necessary for the webcast.

PSI-7977

Abstract (oral)

"Once Daily PSI-7977 plus PegIFN/RBV: Rapid Virologic Suppression in Treatment Naive Patients with HCV GT2/GT3 in a Phase 2b Trial" will be presented in the HCV Drug Development session on Friday, April 1 at 4:15pm CET. Authors of the study are Lalezari, J. et al.
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[continues with 5 or 6 other abstracts.]
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Note that this ISN'T the trial I'm on AFAICT - I think this was an earlier US based trial. [not relevant if you don't recognise my username]

In either case, I would expect some numbers to knock your socks off in a few days... maybe...

NB: sorry doc  [[NBB: mainly my listening and deducing, rather than anything specific]]

[Juttutin]

Here are the slides from the presentation.  Slide 23 has the 100% SVR12 GT2/3 results.



http://files.shareholder.com/downloads/VRUS/1205754595x0x456180/252018c6-b64f-450e-a9f3-b09898471e07/EASL%202011%20IR%20event%20FINAL_exbackup.pdf

[FoieGras]

Thanks J

This is a game changer, a paradigm shift...the earth moved.

I only wish it had come before I spent 18 mos getting to SVR on SOC + double-dose IFN + hidose RBV.  That was tough.

Oh well, at least all those hours of researching treatments allowed me to see the potential importance of this company's therapy and get a small number of stocks in the company before this announcement. Stock's up to $82, up 20% this week...

Once again thanks for conveying this news which should give hope to all those out there who are still trying to slay the dragon...

[Juttutin]

Pharmasset today revealed the SVR12 (12 weeks post tx completion) results for this study.

I'll give you a hint: the percentage figure of the 24 patients who were still undetectable 12 weeks after 12 weeks of treatment starts with a one, ends in a zero, and isn't ten.

I'd provide a link, except I suspect this forum is being trawled by investment analysts at the moment, and they can do their own legwork; also, as a 'rumour' this is more likely to increase (rather than diminish) the interest in tomorrow's announcement.

Suffice to say, the info is publicly available out there on the web.

[Juttutin]

Found the full abstract:

Summary (by me):

Tx: PSI-7977 + SOC for 12 weeks dosing, then followup for SVR
25 enrolled (Genotypes 2 & 3), 1 dropped out after one day, leaving 24 it the trial
23 of 24 UND by day 14; 24 of 24 UND by week 12
12 weeks post-tx followup data to be presented!!!  no hints in abstract what they might be.

Now *IF* 24 of 24 are still UND 12 weeks following only 12 weeks treatment, while the 24 week SVR data might not be available yet, that will be big news!  On the other hand, if more than a couple have the virus back again at detectable levels, then PSI-7977 suddenly doesn't look quite so awesome.

Given that they've scheduled an investor webcast the following day; I suspect it will go one way or the other, more than 'kinda-positivish-but...'

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Background:  PSI-7977 is a novel uridine nucleotide analog in development for treatment of all HCV genotypes. This phase 2b study is assessing safety and efficacy of PSI-7977 against genotypes 2 (GT2) and 3 (GT3).

Methods: 25 treatment-naïve non-cirrhotic patients with HCV GT2 or GT3 and RNA >50,000 (4.7 log10) IU/mL were enrolled across seven US sites. Subjects receive PSI-7977 400 mg QD with pegylated interferon and ribavirin (PegIFN/RBV) for a total of 12 weeks.

Results: 25 patients with HCV GT2 (n=15) or GT3 (n=10) were enrolled. Baseline HCV RNA was ~6.2 log10 IU/mL (4.9-7.4 log10). At IL28B SNP (rs12979860), 7 were C/C, 16 C/T, 2 T/T. One subject (GT3) was lost to follow up after day 1. All remaining subjects (n=24) have completed > 4 weeks of therapy. Significant and consistent antiviral activity was observed throughout the first four weeks of PSI-7977/PegIFN/RBV, with a mean change in HCV RNA of -5.0 log10 IU/mL. HCV RNA below limit of quantitation (< LOQ, < 43 IU/mL) was observed in all subjects with 23/24 subject's HCV RNA levels < LOQ by day 14. 23/24 evaluable subjects had HCV RNA < LOQ by day 21, with all 24 achieving RVR (< LOD, 15 IU/mL; 24 of 25 enrolled; 95%). There was no difference in time to HCV RNA < LOQ or < LOD based on IL28B genotype or HCV genotype.

Preliminary safety and tolerability for the first 4 weeks of therapy revealed no serious adverse events (SAEs) and no adverse events (AEs) leading to treatment discontinuation. Safety laboratory changes and AEs were similar to clinical experience with PegIFN/RBV. A decrease in serum ALT was observed coincident with HCV RNA decline.

Conclusions: PSI-7977 demonstrated potent antiviral activity in treatment-naïve patients with GT2 and GT3, with no SAEs or dose-limiting toxicity. 24 of 25 subjects achieved HCV RNA < LOD by day 28, for an overall RVR of 95%. No viral breakthrough was observed during the first 4 weeks of therapy. SVR12 will be presented. Data from this study support larger studies of PSI-7977 in patients with non-1 HCV genotypes.

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http://www1.easl.eu/easl2011/program/Orals/325.htm

[James10500]

Thanks for posting, this is good news.  Last I saw this drug was in phase 1.