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[DewDiligence]

INHX Starts Phase-1b Trial of INX-189

[INX-189 is structurally and functionally similar to IDIX’s IDX184 and VRUS’ PSI-938; all of them are prodrugs of a monophosphate nucleotide analog of guanosine. Until recently, IDIX had a clear lead in timing among these drugs, but this is no longer true insofar as IDX184 is on FDA clinical hold.

The phase-1b trial described here is unusual in that it contains two cohorts that test INX-189 in combination with ribavirin (but not IFN). Moreover, the trial includes seven days of dosing, rather than the usual three days for phase-1b studies.]

http://finance.yahoo.com/news/Inhibitex-Initiates-Phase-1b-bw-2644796483.html?x=0&.v=1

›Monday November 1, 2010, 7:00 am

ATLANTA--(BUSINESS WIRE)-- Inhibitex, Inc. (NASDAQ: INHX), announced today that it has initiated a Phase 1b, multiple ascending dose (MAD) clinical trial of INX-189, its nucleotide polymerase inhibitor in development for the treatment of 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 anti-viral activity of INX-189 administered orally once daily for seven days in treatment naïve patients with HCV genotype 1. Each treatment cohort will include 10 patients, eight of which will receive INX-189 and two of which will receive placebo. The first cohort in the Phase 1b study will receive 9 mg of INX-189 once daily. In addition to evaluating INX-189 as monotherapy, the Company plans to evaluate two dose levels of INX-189 administered once daily for seven days in combination with ribavirin, which is one of the drugs currently approved for the treatment of HCV. The dose levels of INX-189 to be evaluated in combination with ribavirin will be determined based upon the results of the monotherapy cohorts.

“The initiation of this proof of concept study in patients with chronic hepatitis C marks an important milestone in the clinical development of INX-189,” stated Dr. Joseph Patti, Senior Vice President and Chief Scientific Officer of Inhibitex, Inc. “We believe that dosing INX-189 both as monotherapy and in combination with ribavirin in this study will enhance our ability to assess the anticipated anti-viral synergies of the two agents and allow us to better define the most appropriate doses of INX-189 to evaluate in future clinical trials.”

Inhibitex is developing a series of proprietary nucleotide inhibitors that target the RNA-dependent RNA polymerase (NS5b) of HCV. The Company believes that its nucleotides possess several pharmacological advantages over other HCV nucleosides or nucleotides in clinical development, including a more efficient conversion into their active anti-viral form, a more favorable resistance profile, and anti-viral synergy when used in combination with ribavirin. INX-189 is a protide of a 2’-C-methylguanosine analogue, which, based on in vitro data, the Company believes is the most potent HCV nucleotide polymerase inhibitor currently in clinical development. The Company believes that preclinical and clinical studies of INX-189 completed to-date support its potential as a potent, once-daily oral therapy amenable to combination with other anti-virals for the treatment of patients with all known genotypes of HCV.

About Inhibitex

Inhibitex, Inc. is a biopharmaceutical company focused on developing products to prevent and treat serious infectious diseases. The Company’s clinical stage pipeline includes FV-100, a bicyclic nucleoside inhibitor in Phase II development for the treatment of shingles, and INX-189, a nucleotide polymerase inhibitor in development for the treatment of chronic infections caused by hepatitis C virus (HCV). The Company also has additional HCV nucleotide polymerase inhibitors in various stages of preclinical development and has licensed the use of its proprietary MSCRAMM® protein platform to Pfizer for the development of active staphylococcal vaccines. For additional information about the Company, please visit www.inhibitex.com.‹