Biotech Values

[DewDiligence]

IDIX Starts Phase-1/2 Monotherapy Study of IDX184

[This trial actually opened for business in December, as I noted in #msg-34493338. IDIX evidently held the announcement until today so the news would seem “fresher” for the JPM conference this week.

IDX184 is a nucleoTide prodrug for HCV that differs from the defunct NM283 in several ways (#msg-26915921). As was the case with ANDS’ phase-1b trial for ANA598 (#msg-34678306), this trial is limited to three days of treatment in order to reduce the risk of cross-resistance to other HCV treatments; this is the FDA’s new requirement for proof-of-concept monotherapy trials in HCV patients.

Separately, this PR says that IDIX ended 2008 with $46M in cash, which is consistent with prior guidance.]

http://finance.yahoo.com/news/Idenix-Pharmaceuticals-prnews-14028855.html

›Monday January 12, 2009, 9:00 am EST

CAMBRIDGE, Mass., Jan. 12 /PRNewswire-FirstCall/ -- Idenix Pharmaceuticals, Inc. (Nasdaq: IDIX ), a biopharmaceutical company engaged in the discovery and development of drugs for the treatment of human viral and other infectious diseases, today announced that it has initiated a proof-of-concept study of IDX184, a liver-targeted nucleotide prodrug candidate for the treatment of HCV under an Investigational New Drug application (IND) with the U.S. Food and Drug Administration (FDA). The study is evaluating IDX184 in treatment-naive hepatitis C genotype-1 infected patients.

"We are very pleased with the progress that we have made in our hepatitis C discovery program in 2008, having successfully advanced IDX184 from IND to a proof-of-concept study, while simultaneously advancing two additional HCV discovery programs into IND-enabling preclinical studies," said Jean-Pierre Sommadossi, Ph.D., chief executive officer of Idenix. "As we work to finalize a partnership for our lead HIV drug candidate, our goal in 2009 is to become the first biopharmaceutical company with innovative drugs from three major classes of direct-acting hepatitis C antivirals in clinical development."

The proof-of-concept trial in HCV-infected patients is being conducted at multiple centers around the world. The trial design is a phase I/II, double-blind, placebo-controlled, dose-escalation study to evaluate the safety and antiviral activity of IDX184 in treatment-naive adult patients infected with chronic hepatitis C. The study will evaluate four doses of IDX184, ranging from 25 to 100 mg once-per-day, administered for three days. Each cohort of the study will evaluate ten patients randomized eight to IDX184 and two to placebo.

About IDX184

IDX184 is a once-daily, oral nucleotide prodrug candidate based on Idenix's proprietary liver-targeting technology. This technology enables the delivery of high levels of nucleoside triphosphate in the liver, potentially maximizing drug efficacy and limiting systemic side effects. In HCV genotype-1 infected chimpanzees, once-daily oral administration of 10 mg/kg/day of IDX184 produced a mean viral load reduction of 2.3 log10 after four days of dosing. In a phase I study in healthy volunteers evaluating doses ranging from 5 to 100 mg/day, IDX184 was safe and well-tolerated; the most common adverse event reported in this study was dizziness and it was more frequently reported in subjects receiving placebo.

2008 Financial Guidance

Idenix today reported that it ended 2008 with approximately $46 million of cash, cash equivalents and marketable securities, within the range of the company's prior cash guidance. The company's 2008 financial results have not yet been audited.

About Idenix

Idenix Pharmaceuticals, Inc., headquartered in Cambridge, Massachusetts, is a biopharmaceutical company engaged in the discovery and development of drugs for the treatment of human viral and other infectious diseases. Idenix's current focus is on the treatment of infections caused by hepatitis C virus and HIV. For further information about Idenix, please refer to www.idenix.com.‹