FV-100 shows promise as an anti-shingles drug from phase 2 clinical trial
14 December 2010
Key outcome from phase II trial of FV-100, a potential anti-shingles drug
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Inhibitex, Inc. reported on Monday 13th December Promising Top-Line Results from Phase II Trial of FV-100 for the Treatment of Shingles and that they had achieved clinical 'proof-of-concept' in Shingles Patients.
FV-100 is a drug developed by Professor Chris McGuigan's research group at the Welsh School of Pharmacy.
This study was the first clinical trial to assess the antiviral activity of FV-100, included 350 shingles patients and compared two once-daily doses of FV-100 (200 mg and 400 mg) to an active control, valacyclovir, one of the most commonly-used antiviral drugs to treat shingles. Valacyclovir was administered three times per day at 1,000 mg per dose, or 3,000 mg daily. Treatment was continued for a week and the patients followed up for a further three weeks.
Three-dimensional structure of FV-100.
Numerically favorable treatment differences were observed for both doses of FV-100 compared to valacyclovir for the primary composite endpoint of the study, defined as the reduction in the severity and duration of shingles-associated acute pain over the first 30 days post-infection, or the Burden of Illness (BOI30 AUC). There were also favorable treatment differences observed for key secondary pain endpoints, including the reduction in the severity and duration of shingles-associated pain over 90 days (BOI90 AUC) and the incidence of post herpetic neuralgia, or PHN. The treatment differences observed between either of the FV-100 cohorts and the valacyclovir-treated subjects were not statistically significant. FV-100 was generally well tolerated at both dose levels, and demonstrated a similar adverse event profile as compared to valacyclovir.
Further details of the results of the trial are published on the Inhibitex web-site
Inhibitex supported Team in Prof McGuigan's lab
l-r. Karoline Madela (PhD), Dr Maria Arrica (post doc), Sarah Jones (tech), Claire Bourdin (PhD), Emma Barrett (PhD)
Prof McGuigan, in welcoming the news, said: 'The successful completion of 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 showed the efficacy of this drug, which now has a good chance to emerge as a new medicine for this devastating disease'.
Professor Gary Baxter, Head of the Welsh School of Pharmacy, on hearing this news said
'The Welsh School of Pharmacy has long history of innovative pharmaceutical scientific research but we are especially proud of Professor McGuigan and his colleagues on this landmark achievement. The successful clinical trial of a drug invented in this School is a very significant event and a perfect example of our key mission: discovery with the purpose of alleviating human suffering'.
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.
More information about Inhibitex, Inc click here
