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. FV100 was given once-daily while valacyclovir was given 3 times a day.
Shingles is a viral infection, with an estimated 2.5M new cases every year. It is generally characterized by skin lesions or rash, acute infection-related pain, and in many cases, post herpetic 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 (200mg or 400mg) compared to valacyclovir (3 x 1000mg) 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. Further details of the results of the trial are published on the Inhibitex web-site
Professor McGuigan, of the University’s Welsh School of Pharmacy, 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, added: “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.”
Notes for Editors
For further information please contact:
Professor Chris McGuigan,
Welsh School of Pharmacy,
Telephone +44 029 2087 4537
029 20 875596
Cardiff University is recognised in independent government assessments as one of Britain’s leading teaching and research universities and is a member of the Russell Group of the UK’s most research intensive universities. Among its academic staff are two Nobel Laureates, including the winner of the 2007 Nobel Prize for Medicine, Professor Sir Martin Evans.
Founded by Royal Charter in 1883, today the University combines impressive modern facilities and a dynamic approach to teaching and research. The University’s breadth of expertise in research and research-led teaching encompasses: the humanities; the natural, physical, health, life and social sciences; engineering and technology; preparation for a wide range of professions; and a longstanding commitment to lifelong learning.
Inhibitex, Inc. is a biopharmaceutical company focused on developing products to prevent and treat serious infectious diseases. In addition to FV-100, the Company’s clinical stage pipeline includes INX-189, a nucleotide polymerase inhibitor in Phase 1b development for the treatment of chronic infections caused by hepatitis C virus (HCV). The Company also has additional HCV nucleotide polymerase inhibitors in various stages of preclinical development, and has licensed the use of its proprietary MSCRAMM® protein platform to Pfizer for the development of active staphylococcal vaccines. For additional information about the Company, please visit www.inhibitex.com .