UK-based Phynova , a developer of prescription pharmaceuticals derived from Chinese botanical medicines, has commenced a Phase IIa US trial with PYN17, its lead drug candidate for the relief of inflammation and other symptoms suffered by patients with chronic hepatitis C virus infection.
The agent is based on a novel formulation of highly-purified extracts of four plants which, individually, have been used to treat liver diseases in Asia and Europe. There are no treatments currently available to effectively manage the debilitating symptoms suffered during chronic HVC infection such as fatigue, muscle aches, anorexia and abdominal pain, noted Phynova.
The randomized, double-blind, placebo-controlled study in five sites in the USA will evaluate safety and efficacy in 36 patients suffering with chronic HCV, for whom approved treatments such as pegylated interferon and ribavirin have either failed or are not appropriate. Patients will be dosed over the period of a month and monitored using a recognized and well-validated assortment of quality-of-life scores and liver function tests to evaluate patient response and alleviation of disease symptoms. Preliminary safety and efficacy results will be available by the end of the year, the firm stated.
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