Replies to post #88838 on Biotech Values

[DewDiligence]

IDIX:

...these [IDX184] data are totally in line with expectations, but what may not be earth shattering for you might be a big deal to less savvy investors who saw only a .7ish log decline (at the highest dose no less) and thought 184 lacked enough punch - i.e. they did not appreciate the fact steady state was not achieved in the 3 day POC trial, and in fact a disclosure that the lowest dose now shows > 1 log delta over SOC might be news.

Agreed—the notion that IDX184 was insufficiently potent, which was trumpeted by some sell-side analysts in July (e.g. #msg-39763035), can now be put to rest.

[DewDiligence]

I reposted today’s IDIX PR because the prior post omitted the financial
information at the end of the PR. I also added some brief annotations.

http://finance.yahoo.com/news/Idenix-Pharmaceuticals-prnews-3110464853.html/print?x=0

›Idenix Pharmaceuticals Highlights Progress in Three HCV Programs

• Interim analysis of 50 mg cohort demonstrates potent HCV antiviral activity at 14 days for IDX184, a nucleotide polymerase inhibitor, in combination with PegIFN/Ribavirin

• IDX375, a non-nucleoside polymerase inhibitor, exhibited favorable pharmacokinetic properties in a Phase I healthy volunteer study

• Clinical Trial Application filed in December 2009 for IDX320, a next-generation protease inhibitor

Monday January 11, 2010, 6:45 am EST

CAMBRIDGE, Mass., Jan. 11 /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 significant progress in three HCV programs. Idenix will provide a business update on these three HCV development programs and on its partnered programs during a presentation by Jean-Pierre Sommadossi, Ph.D., chairman and chief executive officer, to financial analysts and investors at the 28th Annual J.P. Morgan Healthcare Conference in San Francisco on Thursday, January 14 at 8:00 a.m. PST.


IDX184: Nucleotide HCV Polymerase Inhibitor

The phase II 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 pegylated interferon and ribavirin in treatment-naive HCV genotype 1-infected patients. Patients will receive a daily dose of IDX184 or placebo plus pegylated interferon and ribavirin for 14 days and then continue on pegylated interferon and ribavirin for an additional 14 days. Antiviral activity will be assessed at the 14-day and 28-day time points. Four dosing regimens of IDX184 ranging from 50 to 200 mg per day will be evaluated. In the 100 mg and 200 mg cohorts, QD and BID regimens will be compared. Each cohort includes 20 patients randomized 4:1, IDX184:placebo. This study is being conducted at multiple centers in the United States and Argentina.

Interim analysis of the first 10 patients randomized into the first cohort (50 mg QD):

Patients with Undetectable
Median Change in HCV RNA Viral Load at Day 14
Cohort (log10) at Day 14 (<15 IU/mL)
------ ------------------------ -----------------------------

50 mg/day IDX184 +
PegIFN/Ribavirin (n=8) -3.66 2
----------------------- ----- ---

Placebo +
PegIFN/Ribavirin (n=2) -1.70 0
----------------------- ----- ---

[In other words, IDX184 has potent antiviral activity even at this very low dose.]

Median ALT and AST levels, markers of liver injury, improved during treatment. There were no serious adverse events on treatment, no treatment discontinuations, and laboratory profiles were comparable to standard PegIFN/Ribavirin treatment. [I.e., IDX184 was safe and well tolerated.]

"We are very encouraged by these interim data for IDX184 combined with pegylated interferon and ribavirin and look forward to seeing additional data as the study progresses," said Douglas Mayers, M.D., Idenix's executive vice president and chief medical officer.


IDX375: Non-Nucleoside HCV Polymerase Inhibitor

A Phase I single ascending dose study evaluating the safety, tolerability and pharmacokinetics of IDX375 in healthy volunteers is ongoing. The first five cohorts (25 mg QD, 50 mg QD, 100 mg QD, 200 mg QD and 200 mg BID; 6 active:2 placebo) in this double-blind, placebo-controlled study have been completed. Data suggest favorable plasma exposure of IDX375 with a long elimination half-life of 32-40 hours demonstrating the potential for once- or twice-daily dosing in patients. IDX375 was generally safe and well tolerated. There were no significant lab abnormalities. The most common adverse event was mild diarrhea (3/30 subjects). Additional cohorts with higher single and multiple doses are planned.


IDX320: HCV Protease Inhibitor

[This is presumably the drug formerly known as IDX316.]

A Clinical Trial Application [the planned phase-1 trial is evidently ex-US or this would be called an IND rather than a CTA] for a new protease inhibitor clinical candidate, IDX320, was filed in December 2009. IDX320 is a non-covalent macrocyclic inhibitor with nanomolar potency, broad genotypic coverage and a favorable preclinical pharmacokinetic profile supporting the potential for once-daily dosing in man.

"We are pleased with these early data from our clinical programs and look forward to their continued advancement throughout the year," said Jean-Pierre Sommadossi, Ph.D., chairman and chief executive officer of Idenix. "In addition, we are excited about our new protease inhibitor clinical candidate, IDX320, and expect to begin a phase I clinical trial soon. With three promising clinical programs that span major HCV drug classes, Idenix is well positioned to play an important role in the transformation of the HCV treatment paradigm."


2009 Financial Guidance

Idenix today reported that it ended 2009 with approximately $48.1 million of cash, cash equivalents and marketable securities. The company's 2009 financial results have not yet been audited.‹