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Re: mcbio post# 101268

Wednesday, 09/01/2010 7:10:03 AM

Wednesday, September 01, 2010 7:10:03 AM

Post# of 252939
INHX Completes Phase-1a Trial of INX-189

[The PR says a 3-day phase-1b monotherapy study will start during 4Q10. I previously questioned the seriousness of the INX-189 program in #msg-53156241.]

http://finance.yahoo.com/news/Inhibitex-Successfully-bw-2560650544.html?x=0&.v=1

›Wednesday September 1, 2010, 7:00 am

ATLANTA--(BUSINESS WIRE)--Inhibitex, Inc. (Nasdaq: INHX - News), 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® protein platform to Pfizer for the development of staphylococcal vaccines. For additional information about the Company, please visit www.inhibitex.com.‹

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