The trial was a randomized, double-blind, placebo-controlled, multi-center, dose escalation study assessing the safety and efficacy of F351 for Hepatic Fibrosis in Chronic Viral Hepatitis B patients in China.
The Phase II study randomized 168 patients into 4 dose-escalating groups (placebo; 60 mg/tid; 90 mg/tid; and 120 mg/tid) with a primary endpoint of the reduction of the liver fibrosis score (Ishak Scoring System) by one grade before and after the F351 treatment, based on pathology analysis from liver biopsies. The secondary endpoints included the reduction of titers of HBV DNA, reduction of liver Fibroscan kpa score, reduction of liver inflammation score, and improvement of ALT level. The study met its primary endpoint of a statistically significant improvement in the liver fibrosis score over the 52-week treatment versus placebo (p=0.025). The 90 mg/tid (270 mg/day) group showed the best Ishak score improvement.
F351 was generally well tolerated in this study. In patients treated with placebos, 60 mg/tid F351, 90 mg/tid F351, and 120 mg/tid F351, respectively, rates of adverse events of special interest (AESIs) were as follows: rates of skin events were 11.63%, 4.76%, 7.14%, and 7.32%; rates of gastrointestinal events were 23.26%, 21.43%, 16.67%, and 19.51%; and rates of serious adverse events (SAEs) were 4.65%, 2.38%, 2.38%, and 7.32%.
“I am thrilled by the initial results of the Phase II study, which underscores the potential for F351 to benefit millions of liver fibrosis patients worldwide,” said Dr. Ying Luo, President of GNI Group. “These findings are very exciting given the same underlying molecular mechanisms for fibrosis in various types of organs and the lack of an approved drug for liver fibrosis specifically.”
More detailed results and the final report of the Phase II study will be published later at medical conferences and/or medical journals in the future. In China, F351 was granted a Major Innovative Drug status, which provides GNI Group a fast track for regulatory review and potentially faster approval. GNI Group intends to announce the strategic direction for F351 in late September or early October for the China market, as well as further steps for the U.S. and Japanese markets.
F351 is a New Chemical Entity (NCE) derivation of Etuary®, which inhibits hepatic stellate cell proliferation and TGF-β signaling pathway, both of which play major roles in the fibrosis of internal organs. GNI Group has 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 Ltd. does not expect the aforementioned matter will impact financial results for the year ending December 31, 2020.
Source: Company Press Release