TOKYO--(BUSINESS WIRE)--GNI Group Ltd., (“GNI Group”; TOKYO: 2160) has received a recommendation from the independent data monitoring committee (IDMC) reviewing the F351 drug candidate’s Phase II liver fibrosis trial in China to end the enrollment of new patients in the trial based on positive efficacy results achieved to date. Currently, 175 patients out of an original 240 patient target have been enrolled in the trial.
In 2015 GNI Group initiated the Phase II trial to study the safety and efficacy of F351 in the treatment of liver fibrosis caused by chronic Hepatitis B virus infection, with a randomized, double-blind, placebo-based multi-dose, multi-center dosage exploration involving 13 Class AAA hospitals throughout China. The primary endpoint of the trial is the improvement of ratio of Ishak score of liver fibrosis by one grade. On Sunday September 23rd, the IDMC disclosed its review of the interim safety and efficacy outcomes in the trial. The Committee found that F351 demonstrated in general a favorable safety profile. Dose-response had been observed, with the best efficacy in the 270 mg/day arm (90 mg/tid). The IDMC recommended the continuation for the remaining 36 patients undergoing treatment through the 52 week regime prior to completing the trial.
The recommendation to end enrollment of additional patients is a significant and positive development for GNI Group, its shareholders and the patients with liver fibrosis. The China Phase II trial is expected to be completed mid-summer 2019, with final results to be disclosed and presented to the international scientific community. In the meantime, GNI Group will proceed with its preparation for a Phase III trial for F351 in China and the review of the U.S. Phase I trial data.
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. GNI Group has international patent rights for F351, including China, Japan, Australia, Canada, the United States and Europe.
About GNI Group
GNI Group Ltd. is a multinational pharmaceutical company headquartered in Tokyo, with primary business units of pharmaceuticals and medical devices with subsidiaries in Hong Kong, Shanghai, Beijing and the United States. For further information, please visit www.gnipharma.com.