FV-100, the anti-shingles drug developed in collaboration with Professor Chris McGuigan’s research group at the Welsh School of Pharmacy, had promising results in its phase 2 trial, pharmaceutical company Inhibitex has reported.
Inhibitex announced that they had achieved clinical ‘proof-of-concept’ in shingles patients.
The study, the first clinical trial to assess the antiviral activity of FV-100, involved 350 shingles patients. It compared FV-100 to an active control, valacyclovir, one of the most commonly-used antiviral drugs to treat shingles. FV-100 was given once-daily while valacyclovir was given 3 times a day.
Shingles is a viral infection, with an estimated 2.5 million new cases every year. It is generally characterised by skin lesions or rash, acute infection-related pain, and in many cases, postherpetic neuralgia, which is a painful and often debilitating chronic complication which can last for months or possibly years.
Favourable treatment differences were observed for two doses of FV-100 (200 mg or 400 mg) compared to valacyclovir (3 x 1,000 mg) for the severity and duration of shingles-associated acute pain over the first 30 days post-infection. There were also favourable treatment differences observed on other points, including the reduction in the severity and duration of shingles-associated pain over 90 days and the incidence of post herpetic neuralgia. 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.
Professor McGuigan said: “The successful completion of this pivotal phase 2 trial marks an important turning point in the development of FV-100 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, commented: “The Welsh School of Pharmacy has a 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.”
(Source: Cardiff University)
For more information, see Chicken Pox, Shingles and Postherpetic Neuralgia.