Replies to post #94207 on Biotech Values

[DewDiligence]

IDX184 addendum: These data ought to be good enough for IDIX to ink a nice partnership deal—either for IDX184 alone or for a package of IDX184 and one or more of IDIX’s other HCV drug candidates.

[go seek]

IDIX - Very nice indeed... Big jump given the 100 mg dose... This has to piqué industry interest... Higher doses of 150 mg & 200 mg IDX 184 may provide "blowout" numbers.

[DewDiligence]

IDIX: Several Wall Street analysts penned bullish reports today, although they have no particular insights not already covered in the discussion on this board. I’ll post some of the summaries later.

[mcbio]

VRUS - Interim PSI-7977 Phase 2a HCV Data

[Obviously not apples-to-apples as this is a 28 day study compared to a 14 day study for IDX184, but any comments on these results compared to the IDX184 results?]

http://finance.yahoo.com/news/Pharmasset-Announces-Interim-prnews-3133874973.html?x=0&.v=1

Pharmasset Announces Interim Data from an Ongoing 28-day Phase 2a Study with PSI-7977 for the Treatment of Chronic Hepatitis C Infection

PRINCETON, N.J., April 15 /PRNewswire-FirstCall/ -- Pharmasset, Inc. (Nasdaq:VRUS - News) announced today interim efficacy and safety results from its ongoing 28-day phase 2a study with PSI-7977 dosed once daily in combination with Pegasys® (peginterferon alfa 2a) and Copegus® (ribavirin) in patients with hepatitis C virus (HCV) genotype 1 who have not been treated previously. PSI-7977 is Pharmasset's nucleotide analog for the treatment of HCV. The Company announced the interim results in conjunction with the European Association for the Study of Liver Congress that commenced in Vienna, Austria on April 14, 2010.

Interim Safety and Efficacy Data

The study is fully enrolled with 63 patients. Thirty-eight patients have completed 28 days of therapy, out of which, eight of ten patients receiving 100mg QD, nine of nine patients at 200mg QD doses, and ten of eleven patients receiving the 400 mg QD dose, have achieved a Rapid Virologic Response (RVR), defined as an undetectable HCV viral load (<15 IU/ml) as measured by Roche HCV TaqMan assay 28 days after the initiation of treatment.

Interim 28-day RVR efficacy data from the trial are summarized as follows:

Study Arm
Patients with Undetectable Viral Load (<15 IU/ml) at Day 28

100mg PSI-7977 QD + Pegasys + Copegus
8 of 10

200mg PSI-7977 QD + Pegasys + Copegus
9 of 9

400mg PSI-7977 QD + Pegasys + Copegus
10 of 11

Pegasys + Copegus
2 of 8

"To date, this drug candidate appears safe and well tolerated" stated M. Michelle Berrey, M.D., MPH, Chief Medical Officer of Pharmasset. This study is ongoing and Pharmasset anticipates reporting the complete data set for all dosing cohorts through day 28 later this quarter.

About the Phase 2a trial

The Phase 2a trial is completely enrolled with 63 chronic hepatitis C infected patients who have not been treated previously. The primary goal of the study is to determine the safety and tolerability of PSI-7977 in combination with pegylated interferon and ribavirin. The primary efficacy endpoint of the trial will be the proportion of patients who achieve an RVR. Patients will continue to be followed through a Sustained Virologic Response (SVR) endpoint. Patients were randomized to receive one of four treatments:

•16 subjects taking PSI-7977 100mg QD in combination with Pegasys® and Copegus® for four weeks, followed by 44 weeks of Pegasys® and Copegus®
•18 subjects taking PSI-7977 200mg QD in combination with Pegasys® and Copegus® for four weeks, followed by 44 weeks of Pegasys® and Copegus®
•15 subjects taking PSI-7977 400mg QD in combination with Pegasys® and Copegus® for four weeks, followed by 44 weeks of Pegasys® and Copegus®
•A control arm of 14 subjects taking only Pegasys® and Copegus®

About Pharmasset

Pharmasset is a clinical-stage pharmaceutical company committed to discovering, developing, and commercializing novel drugs to treat viral infections. Pharmasset's primary focus is on the development of oral therapeutics for the treatment of hepatitis C virus (HCV) and, secondarily, on the development of Racivir(TM) for the treatment of human immunodeficiency virus (HIV). Our research and development efforts focus on nucleoside/tide analogs, a class of compounds which act as alternative substrates for the viral polymerase, thus inhibiting viral replication. We currently have four clinical-stage product candidates. RG7128, a nucleoside analog for chronic HCV infection, is in two Phase 2b clinical trials in combination with Pegasys(R) plus Copegus(R) and is also in the INFORM studies, the first series of studies designed to assess the potential of combinations of small molecules without Pegasys(R) and Copegus(R) to treat chronic HCV. These clinical studies are being conducted through a strategic collaboration with Roche. Our other clinical stage candidates include PSI-7977, an isomer of PSI-7851 and an unpartnered, next-generation HCV nucleotide analog that is in a Phase 2a trial, and the third-generation purine analog PSI-938 in Phase 1. Racivir, for the treatment of HIV, has completed a Phase 2 clinical trial. We also have in our pipeline an additional purine nucleotide analog, PSI-661, an isomer of PSI-879 in advanced preclinical development.

Pegasys® and Copegus® are registered trademarks of Roche.

[DewDiligence]

Here’s the full IDX184 PR from EASL for archival purposes.
I previously posted the pertinent data in #msg-49003061.

http://finance.yahoo.com/news/Idenix-Pharmaceuticals-prnews-3111503245.html?x=0&.v=1

›Idenix Pharmaceuticals Reports Positive Results With IDX184 From Interim Analysis of Phase IIa Hepatitis C Study

• IDX184 50 and 100 mg cohorts in combination with pegylated interferon and ribavirin (PegIFN/RBV) demonstrated a favorable safety profile and potent antiviral activity at 14 days

• Fifty percent of subjects receiving a total daily dose of 100 mg IDX184 achieved undetectable virus levels by Day 14

• Study continuing with enrollment of 150 mg cohort [the 100mg BID cohort will presumably begin when the 150mg qD cohort is completed]

April 15, 2010, 4:23 am EDT

CAMBRIDGE, Mass., April 15 /PRNewswire-FirstCall/ -- Idenix Pharmaceuticals, Inc. (Nasdaq: IDIX ), a biopharmaceutical company engaged in the discovery and development of drugs for the treatment of human viral diseases, today announced interim data from a 14-day, phase IIa clinical trial evaluating IDX184, a novel liver-targeted nucleotide prodrug of 2'-methyl guanosine monophosphate, in HCV-infected patients. Data are being presented at the 45th annual meeting of the European Association for the Study of the Liver being held in Vienna, Austria.

The phase IIa clinical trial, initiated in the fourth quarter of 2009, is a randomized, double-blind, placebo-controlled, sequential dose-escalation study evaluating the safety, tolerability, pharmacokinetics and antiviral activity of IDX184 in combination with PegIFN/RBV in treatment-naive HCV genotype 1-infected patients. Patients receive a daily dose of IDX184 or placebo, plus pegIFN/RBV for 14 days and then continue on PegIFN/RBV for an additional 14 days. The study is evaluating four dosing regimens of IDX184 ranging from 50 to 200 mg per day. In the 100 mg and 200 mg cohorts, once daily (QD) and twice daily (BID) regimens are compared. Each cohort includes 20 patients randomized 4:1, IDX184:placebo.

In the data presented today, IDX184 demonstrated potent dose-dependent antiviral activity when combined with PegIFN/RBV. At Day 14, mean (+/- standard deviation) viral load reductions were 1.2 (+/- 1.1), 2.7 (+/- 1.3), 4.0 (+/- 1.7) and 4.2 (+/- 1.9) log(10) IU/mL in the placebo (n=8), 50 mg IDX184 QD (n=16), 50 mg IDX184 BID (n=8) and 100 mg IDX184 QD (n=8) cohorts, respectively. Half of the subjects receiving a total daily dose of 100 mg IDX184 achieved undetectable virus levels (< 15 IU/mL) by Day 14. Liver injury parameters (ALT and AST) improved (normalized) with all doses of IDX184. Antiviral activity and safety parameters measured after a total daily dose of 100 mg IDX184 did not differ between a QD or BID dosing regimen. The side effect profile of the three-drug combination was consistent with the known side effect profile of PegIFN/RBV alone. The most common adverse events reported were fatigue, myalgia, headache and nausea. No virologic breakthrough was observed during treatment with IDX184 in combination with PegIFN/RBV.

"We are very encouraged by these interim data for IDX184 combined with pegylated interferon and ribavirin as the viral load reductions for the 100 mg cohorts are on par with the first-generation nucleoside in development but at a fraction of the dose," said Douglas Mayers, M.D., Idenix's executive vice president and chief medical officer. "We are currently enrolling the 150 mg once-daily dose cohort and look forward to reporting full data later this year. We believe that with the favorable antiviral activity, safety and resistance profile seen to date, IDX184 could be a potential component of future direct-acting antiviral combination regimens."

"With a high barrier to resistance and broad genotypic coverage, nucleosides and/or nucleotides could become an important part of future combination therapy for hepatitis C patients," said Dr. Fred Poordad, a principal investigator in the study, Chief of Hepatology at the Liver Disease and Transplant Center at Cedars-Sinai Medical Center in Los Angeles. "The interim 50 and 100 mg cohort data for IDX184 in combination with pegylated interferon and ribavirin have been promising and we look forward to the continued clinical development of this drug candidate."‹

[go seek]

IDIX - the value of IDX184 and IDIX should increase with each reported cohort in the IDX184 P2a trial. This turned out to be an excellent way to keep market interest over time... w/ a report ev'ry month or so.

and what does IDIX have besides IDX184?
a ton of catalysts for more increased value... some arguably much more exciting than 184.
#msg-49286390

I see IDIX as a double from here and $8 - $10 before the end of the year.