Phase 2 clinical trial of FV-100 nears completion
18 October 2010
Three-dimensional structure of FV-100.
Inhibitex, Inc. announced on Friday October 15th that it has completed enrollment in a Phase II clinical trial of FV-100 in shingles (herpes zoster) patients. FV-100 is a drug developed by Professor Chris McGuigan's research group at the Welsh School of Pharmacy. The objectives of the trial are to further evaluate the safety of FV-100 and its potential therapeutic benefit in reducing the severity and duration of shingles-associated pain, the incidence of post herpetic neuralgia (PHN), and the time to heal shingles-related lesions.
The Phase II trial is a well-controlled, double-blind study of 350 shingles patients, aged 50 years and older with shingles-associated pain, who were randomized equally to one of three treatment arms: 200 mg or 400 mg FV-100 administered orally once daily, or 1,000 mg valacyclovir administered orally three times per day. Treatment continued for a week, after which patients were followed up for a further three weeks. The Company anticipates top-line data from the trial will be available later in mid-December.
Prof McGuigan, in welcoming the news, said: 'The successful completion of recruitment to this pivotal phase 2 trial marks an important turning point in the development of FV100 as a new drug for shingles. The data from this study should emerge in December, and if successful, it becomes probable that FV100 will emerge as a new medicine for this devastating disease'.
About Shingles and FV-100
Shingles is an infection caused by the reactivation of varicella zoster virus (VZV), the same virus that causes chicken pox. Worldwide, it is estimated that more than 2.5 million new cases of shingles occur each year, and that one in four adults will suffer from shingles during their lifetime. While shingles can develop in adolescents or adults of any age, it occurs predominantly in individuals 40 years of age and older. Shingles is generally characterized by skin lesions or rash, acute infection-related pain, and in many cases, PHN, which is a painful and often debilitating chronic complication that impacts approximately one out of every five shingles patients. PHN can last for months or possibly years, and has been shown to have a measurable and significant impact on patients’ quality of life and functional status.
Published in vitro studies have demonstrated that FV-100, an orally available bicyclic nucleoside analogue, is significantly more potent against VZV, and can inhibit its replication substantially faster than any other antiviral agent currently approved for the treatment of shingles. The Company believes these characteristics, plus a favorable pharmacokinetic profile, support the potential of FV-100 as a highly potent, once-daily oral therapy to reduce the incidence, severity and duration of shingles-related symptoms, including acute pain and PHN.
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