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news.Inhibitex, a biopharmaceutical company, has completed its Phase I clinical trials of FV-100, a highly potent and fast-acting oral compound being developed to treat shingles.
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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 800mg administered once a day and 400mg 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 400mg dose of FV-100 and two received placebo. In the second cohort, 10 subjects received 400mg 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 has reported that in both trials there were no serious adverse events reported and FV-100 appeared to be well tolerated at all dose levels. The company plans to present the full data from these trials later 2009.
The company has also selected lead candidates from its series of proprietary hepatitis C virus nucleoside polymerase inhibitors for evaluation in advanced preclinical and investigational new drug application (IND) enabling studies. Subject to the successful completion of IND-enabling studies, the company’s goal is to initiate a first-in-man study in the first half of 2010.
Russell Plumb, CEO of Inhibitex, said: We are very pleased with the favorable safety and pharmacokinetic results from our Phase I trials of FV-100. 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.