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.
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.
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.
This press release contains "forward-looking statements" within the meaning of The Private Securities Litigation Reform Act of 1995. Such forward-looking statements can be identified by the use of forward-looking terminology such as "may," "plans," "anticipates," "will," or similar expressions, or by express or implied statements with respect to the company's clinical development programs or commercialization activities in hepatitis C, or any other potential pipeline candidate. Such forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause actual results to be materially different from any future results, performance or achievements expressed or implied by such statements. There can be no guarantees that the company will advance any clinical product candidate or other component of its potential pipeline to the clinic, to the regulatory process or to commercialization. In particular, management's expectations could be affected by unexpected regulatory actions or delays; uncertainties relating to, or unsuccessful results of, clinical trials, including additional data relating to the ongoing clinical trials evaluating its product candidates; the company's ability to obtain additional funding required to conduct its research, development and commercialization activities; the company's dependence on its collaboration with Novartis Pharma AG; changes in the company's business plan or objectives; the ability of the company to attract and retain qualified personnel; competition in general; and the company's ability to obtain, maintain and enforce patent and other intellectual property protection for its product candidates and its discoveries. These and other risks which may impact management's expectations are described in greater detail under the caption "Risk Factors" in the company's annual report on Form 10-K for the year ended December 31, 2007 and the Quarterly Report on Form 10-Q for the quarter ended September 30, 2008, as filed with the Securities and Exchange Commission (SEC) and other filings that the company makes with the SEC.
All forward-looking statements reflect the company's expectations only as of the date of this release and should not be relied upon as reflecting the company's views, expectations or beliefs at any date subsequent to the date of this release. Idenix anticipates that subsequent events and developments may cause these views, expectations and beliefs to change. However, while Idenix may elect to update these forward-looking statements at some point in the future, it specifically disclaims any obligation to do so.
Idenix Pharmaceuticals Contact: Media: Teri Dahlman (617) 995-9905 Investors: Amy Sullivan (617) 995-9838
|SOURCE Idenix Pharmaceuticals, Inc.|
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