11 Feb 2009 04:00 AM
Inhibitex Completes Phase I Clinical Trials For FV-100 And Selects Lead HCV Compounds For Advanced Preclinical Studies
Inhibitex, Inc. (NASDAQ: INHX), a biopharmaceutical company focused on the development of products to treat serious infectious diseases, reported that it has completed its Phase I clinical trials of FV-100, a highly potent and fast-acting oral compound being developed to treat shingles (herpes zoster). The recently completed trials include both a multiple ascending dose study in subjects aged 18-55 and a separate study conducted in subjects 65 years of age or older.
The blinded, placebo controlled multiple ascending dose trial was designed to evaluate the safety and pharmacokinetics of five oral doses of FV-100 (100, 200, 400 and 800 mg administered once a day and 400 mg administered twice daily, each for seven days) in healthy subjects aged 18-55. Each dose cohort consisted of six subjects that received FV-100 and two that received placebo.
The blinded, placebo controlled trial in elderly subjects aged 65 years and older was comprised of two cohorts. In the first cohort, 10 subjects received a single 400 mg dose of FV-100 and two received placebo. In the second cohort, 10 subjects received 400 mg of FV-100 administered once daily for seven consecutive days and two received placebo. The purpose of this study was to compare the safety and pharmacokinetics of FV-100 in older individuals, which represent approximately half of all shingles patients, to those of younger subjects from the Company's single and multiple ascending dose Phase I trials.
The Company reported that in both trials there were no serious adverse events reported and FV-100 appeared to be well tolerated at all dose levels. Additionally, pharmacokinetic data demonstrated that all doses maintained mean drug plasma levels of the active form of FV-100 that exceeded the EC50 for approximately 24 hours, supporting the potential for once-a-day dosing in future trials. Finally, the pharmacokinetic profile of FV-100 in elderly subjects was similar to that of younger subjects. These safety and pharmacokinetic findings are consistent with those observed in the Company's Phase I single ascending dose trial, the results of which were reported at ICAAC last year.
The Company plans to present the full data from these trials at a scientific conference later this year.
"We are very pleased with the favorable safety and pharmacokinetic results from our Phase I trials of FV-100," stated Russell H. Plumb, president and chief executive officer of Inhibitex. "We believe these data support advancing the compound into a well-powered, human proof of concept Phase II trial in shingles patients. Subject to FDA review of our Phase I data and proposed protocol, we look forward to initiating such a trial as soon as practical."
The Company also reported that it has selected lead candidates from its series of proprietary HCV nucleoside polymerase inhibitors for evaluation in advanced preclinical and Investigational New Drug application (IND) enabling studies…
The blinded, placebo controlled multiple ascending dose trial was designed to evaluate the safety and pharmacokinetics of five oral doses of FV-100 (100, 200, 400 and 800 mg administered once a day and 400 mg administered twice daily, each for seven days) in healthy subjects aged 18-55. Each dose cohort consisted of six subjects that received FV-100 and two that received placebo.
The blinded, placebo controlled trial in elderly subjects aged 65 years and older was comprised of two cohorts. In the first cohort, 10 subjects received a single 400 mg dose of FV-100 and two received placebo. In the second cohort, 10 subjects received 400 mg of FV-100 administered once daily for seven consecutive days and two received placebo. The purpose of this study was to compare the safety and pharmacokinetics of FV-100 in older individuals, which represent approximately half of all shingles patients, to those of younger subjects from the Company's single and multiple ascending dose Phase I trials.
The Company reported that in both trials there were no serious adverse events reported and FV-100 appeared to be well tolerated at all dose levels. Additionally, pharmacokinetic data demonstrated that all doses maintained mean drug plasma levels of the active form of FV-100 that exceeded the EC50 for approximately 24 hours, supporting the potential for once-a-day dosing in future trials. Finally, the pharmacokinetic profile of FV-100 in elderly subjects was similar to that of younger subjects. These safety and pharmacokinetic findings are consistent with those observed in the Company's Phase I single ascending dose trial, the results of which were reported at ICAAC last year.
The Company plans to present the full data from these trials at a scientific conference later this year.
"We are very pleased with the favorable safety and pharmacokinetic results from our Phase I trials of FV-100," stated Russell H. Plumb, president and chief executive officer of Inhibitex. "We believe these data support advancing the compound into a well-powered, human proof of concept Phase II trial in shingles patients. Subject to FDA review of our Phase I data and proposed protocol, we look forward to initiating such a trial as soon as practical."
The Company also reported that it has selected lead candidates from its series of proprietary HCV nucleoside polymerase inhibitors for evaluation in advanced preclinical and Investigational New Drug application (IND) enabling studies…
