�Inhibitex, Inc. (NASDAQ: INHX), a biopharmaceutical company focussed on the development of products to treat serious infectious diseases, announced today that it has accomplished a Phase I single ascending dose (SAD) clinical trial and initiated a multiple ascending dose (MAD) trial of FV-100, a highly potent and fast-acting compound being developed to treat zoster (herpes shingles).
The double-blind, placebo-controlled SAD trial evaluated the safety and pharmacokinetics of four-spot doses of FV-100 in five cohorts of healthy volunteers (C, 200, 400, and 800 mg, as well as a cd mg food effect grouping). Each cohort consisted of six subjects that received FV-100 and two that received placebo. The Company reported that there were no serious adverse events observed and the combine appeared to be broadly speaking well tolerated in the trial. In addition, pharmacokinetic data demonstrated that all doses evaluated in the trial maintained drug plasma levels of the alive form of FV-100 that exceeded its EC50 for at least 24 hours. The EC50 represents the concentration of a drug that is required for 50% inhibition of viral replication in vitro. The Company plans to present the full data from the SAD trial at the Interscience Conference on Antimicrobial Agents and Chemotherapy ("ICAAC") this fall.
"We are very encouraged by the rising safety and pharmacokinetic profile of FV-100 in piece," stated Russell H. Plumb, president and chief executive officer of Inhibitex. "Subject to the results of the multiple ascending dosage trial, we plan to advance FV-100 into a well powered, proof of concept Phase II clinical trial around the end of 2008 to evaluate both once and twice-daily doses in shingles patients."
The latterly initiated MAD trial in healthy subjects is intentional to assess the safety and pharmacokinetics of little Phoebe oral doses of FV-100 (100, cc, 400 and 800 mg administered once daily and 200 mg administered twice daily, each for seven days). Similar to the SAD test, each vD cohort will consist of six subjects that volition receive FV-100 and deuce that will receive placebo. The Company anticipates completing the MAD trial in the fourth quarter of 2008.
About Shingles
Shingles, also know as herpes zoster, is an infection caused by the reactivation of varicella zoster virus (VZV), the same virus that causes chicken pox. Worldwide, at that place are an estimated 2.5 gazillion cases of shingles each year. Shingles is generally characterized by skin lesions, rash, needlelike pain, and in many cases mail herpetic neuralgia (PHN), a painful and sometimes debilitating condition resulting from nervus damage caused by VZV that stool last for several months or more than. While shingles can develop in adults of any age, it occurs most frequently among those wHO are 40 and older.
About FV-100
Published in vitro studies have demonstrated that FV-100, a bicylcic nucleoside parallel, is more potent against and can inhibit the replication of VZV substantially faster than other antiviral therapeutics currently approved for the
