GNI Group F351 (hydroxyne) treatment of hepatitis B-related liver fibrosis China Phase II research success.

Japan's GNI Group recently announced that a Chinese Phase II clinical study evaluating F351 (hydronidone) treatment of hepatitis B-related hepatic fibrosis has obtained positive results in the main endpoint analysis.
was a randomized, double-blind, placebo-controlled, multi-center, dose-incremental study that evaluated the efficacy and safety of F351 in treating liver fibrosis in patients with chronic hepatitis B in China.
study, 168 patients were randomly divided into four dose incremental groups: placebo, 60mg/TID (3 times a day), 90mg/TID, 120mg/TID.
end point of the study was that, according to the pathological analysis of liver biopsy, the score of liver fibrosis before and after F351 treatment (using the Ishak scoring system) was reduced by one level.
secondary endpoints included a decrease in HBV DNA titration, a decrease in the kpa score for liver fiber scanning, a decrease in the liver inflammation score, and an improvement in ALT levels.
results showed that the study reached its main endpoint: Ishak scores improved best in the 90mg/TID (270mg/day) treatment group over a 52-week treatment period compared to a placebo.
study, the overall tolerance of F351 was good.
rates of adverse events in placebo group, F351 60mg/TID group, 90mg/TID group, 120mg/TID group were 11.63 per cent, 4.76 per cent, 7.14 per cent, 77 per cent, respectively .32%, gastrointestinal events were 23.26%, 21.43%, 16.67% and 19.51%, respectively, and serious adverse events were 4.65%, 2.38%, 2.38% and 7.32%, respectively.
results and final reports of the study will be published in future medical conferences and/or medical journals.
, F351 was granted significant innovative drug status, providing GNI Group with a fast track to regulatory review and potentially faster approval.
GNI Group intends to announce the strategic direction of F351 in the Chinese market in late September or early October, as well as further measures in the US and Japan.
Contini Pharmaceutical Pipeline F351, a wholly owned subsidiary of
GNI Group, is a new chemical entity derived from Etuary® (pirfenidone) that inhibits hepatocellular proliferation and TGF-beta signaling pathways, which play a key role in internal fibrosis.
F351 is primarily developed to treat liver fibrosis caused by alcohol, drugs, obesity or viruses and kidney fibrosis caused by chronic kidney diseases, especially diabetes.
early studies have shown that F351 has good pharmacological and toxicological properties.
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