TOKYO--(BUSINESS WIRE)--GNI USA, Inc., a wholly-owned subsidiary of GNI Group Ltd. (TOKYO:2160), announced the first subject was dosed in the F351 Phase I clinical trial taking place in New Jersey, USA. The primary objective of this trial is to understand the pharmacokinetics and safety of F351 in a diverse ethnic population to supplement the previous Phase I results obtained in China. A total of 48 subjects will be enrolled in the trial and it is expected to be completed by the second half of 2018.
F351 is a New Chemical Entity (NCE) derivation of Etuary®, which inhibits hepatic stellate cell proliferation and also the TGF-β signaling pathway, both of which play major roles in the fibrosis of internal organs. Multiple animal model studies conducted by Shanghai Genomics, Inc. (Shanghai Genomics), a consolidated subsidiary of GNI Group Ltd. (GNI Group), have indicated the efficacy of F351 as a treatment for fibrosis, and in particular as a treatment for both liver and kidney fibrosis. GNI Group has obtained key global patent rights for F351 in a number of countries and regions including China, Japan, Australia, Canada, the United States and Europe.
GNI Group is currently conducting Phase II trials to study the safety and efficacy of this drug candidate in the therapy of liver fibrosis caused by chronic Hepatitis B virus infection, with a randomized, double-blind, placebo-based multi-dose, multi-center dosage exploration in Class AAA hospitals throughout China.
About GNI Group
GNI Group Ltd. is a multinational pharmaceutical company that focuses on pharmaceutical and medical device businesses with headquarters in Tokyo and subsidiaries in China and the United States. For further information, please visit www.gnipharma.com.