CAMBRIDGE, Mass., Oct. 30 /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 presentations of data on IDX184, a once-daily novel liver-targeted nucleotide prodrug of 2'-methyl guanosine (2'MeG)
Data from a three-day, phase I proof-of-concept study evaluating the safety and antiviral activity of IDX184 will be presented. This double-blind, placebo-controlled, monotherapy, dose-escalation study enrolled 41 treatment-naive HCV genotype 1-infected patients into four dosing cohorts (25 mg, 50 mg, 75 mg and 100 mg). IDX184 was well tolerated in this study with no serious adverse events reported and no discontinuations from the study. Patterns of adverse events (AEs) were similar between IDX184- and placebo-treated patients with the most frequent AEs being headache, diarrhea and dizziness. Mean viral load declines ranged from 0.47 log10 in the 25 mg group to 0.74 log10 in the 100 mg group after three days of treatment. In the 75 and 100 mg/day cohorts, patients receiving IDX184 experienced improvements in two key markers of liver injury (AST and ALT), with mean levels of these enzymes decreasing to within normal range. Pharmacokinetic data demonstrated that higher plasma levels of 2'MeG were associated with greater reductions in viral load and ALT levels.
"With favorable safety data and good antiviral activity for IDX184 in HCV patients, these early results are encouraging," said Dr. Jacob Lalezari, principal investigator in the study, Director of Quest Clinical Research and an Assistant Clinical Professor of Medicine at UCSF/Mount Zion Hospital. "Nucleotides may become an essential component of future STAT-C combinations for the treatment of hepatitis C. IDX184 has shown a promising early profile and should be evaluated in longer-term, combination trials."
Results will also be presented from in vitro studies evaluating the combination of IDX184 with other direct-acting antivirals or standard-of-care agents, interferon and ribavirin. These in vitro studies suggest that when IDX184 is combined with compounds from different classes, the antiviral activity may be enhanced, and in some combinations, synergistic. Specifically, the triple combination of IDX184, interferon and ribavirin showed strong synergy in vitro. These in vitro studies also suggest that the combination of IDX184 with other compounds from different classes may suppress the emergence of resistance.
"The in vitro combination data for IDX184 are promising," said David Standring, executive vice president of biology for Idenix. "We look forward to assessing this potential synergy in the next clinical study evaluating IDX184 in combination with pegylated interferon and ribavirin in HCV genotype 1-infected patients."
IDX184 is a novel, liver-targeted nucleotide prodrug of 2'-methyl guanosine, which includes Idenix's proprietary liver-targeting technology. This technology enables the delivery of nucleoside monophosphate to the liver, leading to the formation of high levels of nucleoside triphosphate, potentially maximizing drug efficacy and limiting systemic side effects with low, once-daily dosing.
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 diseases. Idenix's current focus is on the treatment of infections caused by hepatitis C virus. 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 "expect," "plans," "anticipates," "will," "expects," "goal" 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 potential pipeline candidates, including any expressed or implied statements regarding the efficacy and safety of IDX184, the likelihood and success of any future clinical trials involving IDX184 or successful development of novel combinations of direct-acting antivirals for the treatment of hepatitis C. 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; 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, 2008 and the Quarterly Report on Form 10-Q for the quarter ended September 30, 2009, 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.
SOURCE Idenix Pharmaceuticals, Inc.
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