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Inhibitex Successfully Completes Phase 1a Trial of INX-189, Proof-of-Concept Trial in Patients with Chronic Hepatitis C Planned for Q4 2010
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press release
Sept. 1, 2010
ATLANTA, Sep 01, 2010 (BUSINESS WIRE) -- Inhibitex, Inc.
/quotes/comstock/15*!inhx (INHX 1.42, -0.01, -0.70%) , announced today that it has successfully completed a Phase1a, first-in-man, single ascending dose trial of INX-189, its nucleotide polymerase inhibitor in development for the treatment of chronic hepatitis C (HCV) infections. In this trial, 42 healthy volunteers received either a single oral dose of INX-189, ranging from 3 mg to 100 mg, or placebo. The Company plans to present detailed results from this trial during a future scientific meeting. Preliminary data from the trial are as follows:
-- INX-189 was generally well tolerated at all dose levels;
-- No drug-related serious adverse events;
-- No dose-related trends in frequency or type of adverse events; adverse events occurring in more than one subject were headache and nasal congestion;
-- No grade II or higher laboratory abnormality adverse events or clinically significant changes in ECGs; and
-- Pharmacokinetic data supports INX-189's potential for once daily (QD) dosing.
"We are encouraged with the initial safety and pharmacokinetic profile of INX-189 in this first-in-man trial," stated Dr. Joseph Patti, Senior Vice President and Chief Scientific Officer of Inhibitex, Inc. "Based upon the pharmacokinetics observed in this study, we continue to believe that INX-189 has the potential to demonstrate antiviral activity with a low once-daily dose, and we look forward to assessing its ability to reduce HCV RNA viral loads in patients with chronic hepatitis C in a Phase 1b multiple ascending dose trial we plan to start in the fourth quarter."
About Inhibitex
Inhibitex, Inc., headquartered in Alpharetta, Georgia, is a biopharmaceutical company focused on developing products to prevent and treat serious infectious diseases. The Company's pipeline includes FV-100, which is in Phase II clinical development for the treatment of shingles, and INX-189, a nucleotide polymerase inhibitor in development for the treatment of chronic hepatitis C infections. The Company also has additional HCV nucleotide polymerase inhibitors in preclinical development and has licensed the use of its proprietary MSCRAMM(R) protein platform to Pfizer for the development of staphylococcal vaccines. For additional information about the Company, please visit www.inhibitex.com.
SOURCE: Inhibitex, Inc.
Inhibitex, Inc.
Russell H. Plumb
Chief Executive Officer
678-746-1136
rplumb@inhibitex.com
or
Lee M. Stern, CFA
The Trout Group
646-378-2922
lstern@troutgroup.com
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