Inhibitex Reports Positive Interim Safety and Antiviral Data from Ongoing Phase 1b Study of HCV Nucleotide Inhibitor INX-189

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HCV Polymerase Inhibitor INX-189

Looks Promising in Early Study

By Liz Highleyman

SUMMARY: Biopharmaceutical company Inhibitex this month announced preliminary

clinical trial data indicating that its experimental nucleotide hepatitis C

virus (HCV) polymerase inhibitor INX-189 appears safe and demonstrates good

antiviral activity. In a small Phase 1b study of treatment-naive genotype 1

chronic hepatitis C patients treated for 7 days, the higher tested dose of

INX-189, taken once-daily as monotherapy, lowered HCV viral load by about 1 log

and reduced ALT levels.

Below is an edited excerpt from a recent Inhibitex press release describing the

study and its findings.

Inhibitex Reports Positive Interim Safety and Antiviral Data from Ongoing Phase

1b Study of HCV Nucleotide Inhibitor INX-189

- 9 mg and 25 mg QD Doses Demonstrate Significant Reductions in HCV RNA Levels

Atlanta -- January 9, 2011 -- Inhibitex, Inc. (Nasdaq: INHX) today reported

positive preliminary interim safety and antiviral data from the first two

monotherapy cohorts of its ongoing Phase 1b clinical trial of INX-189, an oral

NS5b nucleotide inhibitor being developed to treat chronic infections caused by

hepatitis C virus (HCV).

The trial, which is being conducted under an IND in the United States, is a

double-blind, placebo-controlled, dose escalation study designed to evaluate the

safety, tolerability, pharmacokinetics and antiviral activity of INX-189,

administered orally once-daily for seven days, for the treatment of HCV genotype

1 treatment naive patients. Each treatment cohort in the study is comprised of

10 patients, eight that receive INX-189 and two that receive placebo. In

addition to the 9 mg and 25 mg dose cohorts, the company plans to enroll up to

three more INX-189 monotherapy cohorts in the study, as well as two cohorts that

will receive different doses of INX-189 once daily for seven days in combination

with ribavirin.

INX-189, dosed once-daily at 9 mg and 25 mg for seven days, demonstrated potent

antiviral activity with a mean HCV RNA reduction from baseline levels of -0.71

and -1.03 log10 IU/mL, respectively. The mean HCV RNA decline from baseline

levels observed in patients that received placebo was -0.06 log10 IU/mL. The HCV

RNA declines from baseline were statistically significant from placebo, with

p-values of 0.0156 and 0.0006 in the 9 mg and 25 mg cohorts, respectively. In

addition to the mean reductions in viral load, clinically meaningful decreases

in alanine transaminase (ALT) levels were observed for patients receiving

INX-189 at both dose levels and no patients experienced viral breakthrough. Full

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