Shanghai Sundise Traditional Chinese Medicine (Sundise) has reported encouraging results from its multi-centre, double-blinded, placebo-controlled clinical Phase II study of Fuzheng Huayu (FZHY) tablet for the treatment of liver fibrosis in patients with chronic hepatitis C.
According to the company, the results show that FZHY tablet is safe, well-tolerated and tended to stabilise and improve liver fibrosis in chronic hepatitis C patients with moderate to severe fibrosis.
The company said FZHY is the first traditional Chinese medicine compound to complete such clinical studies in the treatment of liver diseases.
While there is no FDA-approved anti-fibrosis therapy, FZHY is a botanical compound that has been approved in China for liver fibrosis caused by hepatitis B virus.
The company said that this is the first clinical Phase II study of FZHY as botanical drug to evaluate the safety, tolerability, and efficacy on fibrosis in HCV patients who previously failed the anti-viral therapies, cannot receive or refused Interferon based therapy.
The Phase II clinical trial was started in 2010 to assess FZHY with treatment protocol for one year and pre- and post-treatment liver biopsy assessments, with funding provided by Sundise, with eight US medical institutions and a team of liver specialists working together.
SCTI Research Foundation director and lead principal investigator Tarek Hassanein said: "This study assured us about the safety and tolerability of FZHY and its previous reported effects on liver fibrosis in chronic hepatitis patient populations."
FZHY is developed by Sundise, which holds 17 patents including five worldwide patents.
Sundise specialises in the modernisation of traditional Chinese medicine as well as works closely with universities and research institutes across China and the US to carry out studies on therapeutic compounds based on the Chinese traditional medicine.
Image: High-magnification micrograph of a liver with cirrhosis. Photo: courtesy of Nephron.