Published on September 2, 2010 at 6:08 AM
Inhibitex, Inc. (Nasdaq: INHX), 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:
“We are encouraged with the initial safety and pharmacokinetic profile of INX-189 in this first-in-man trial”
- 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."
SOURCE Inhibitex, Inc.,