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Favorable Safety and Pharmacokinetic Data from Single Ascending. Dose Trial Support Compound's Clinical Advancement
ATLANTA, GA, USA | August 6, 2008 | Inhibitex, Inc. (NASDAQ: INHX), a biopharmaceutical company focused on the development of products to treat serious infectious diseases, announced today that it has completed 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 shingles (herpes zoster).
The double-blind, placebo-controlled SAD trial evaluated the safety and pharmacokinetics of four doses of FV-100 in five cohorts of healthy volunteers (100, 200, 400, and 800 mg, as well as a 400 mg food effect group). 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 compound appeared to be generally well tolerated in the trial. In addition, pharmacokinetic data demonstrated that all doses evaluated in the trial maintained drug plasma levels of the active 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 emerging safety and pharmacokinetic profile of FV-100 in man," stated Russell H. Plumb, president and chief executive officer of Inhibitex. "Subject to the results of the multiple ascending dose 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 recently initiated MAD trial in healthy subjects is designed to evaluate the safety and pharmacokinetics of five oral doses of FV-100 (100, 200, 400 and 800 mg administered once daily and 200 mg administered twice daily, each for seven days). Similar to the SAD trial, each dose cohort will consist of six subjects that will receive FV-100 and two 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, there are an estimated 2.5 million cases of shingles each year. Shingles is generally characterized by skin lesions, rash, acute pain, and in many cases post herpetic neuralgia (PHN), a painful and sometimes debilitating condition resulting from nerve damage caused by VZV that can last for several months or more. 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 analogue, is more potent against and can inhibit the replication of VZV substantially faster than other antiviral therapeutics currently approved for the treatment of shingles. Inhibitex believes these characteristics provide the potential for FV-100 to reduce the incidence and severity of shingles-related symptoms, including acute pain and PHN.
About Inhibitex
Inhibitex, Inc., headquartered in Alpharetta, Georgia, is a biopharmaceutical company focused on developing products to treat and prevent serious infectious diseases. In addition to FV-100, the Company's development pipeline includes a series of HCV nucleoside polymerase inhibitors and HIV integrase inhibitors. Inhibitex has also licensed its proprietary MSCRAMM(R) protein technology to Wyeth for the development of staphylococcal vaccines and to 3M for the development of diagnostics. For additional information about the Company, please visit www.inhibitex.com.
SOURCE: Inhibitex, Inc. |
