Japanese biotech company GNI Group has announced it will cease enrolment of new patients in its Phase 2 liver fibrosis trial for the drug candidate F351 in China. This decision follows a recommendation from an independent data monitoring committee (IDMC) based on positive efficacy results achieved to date.

As of now, 175 out of the initially targeted 240 patients have been enrolled in the trial, which began in 2015. The study was designed to evaluate the safety and efficacy of F351 in treating liver fibrosis caused by chronic Hepatitis B virus infection. The trial employs a randomized, double-blind, placebo-controlled, multi-dose approach across 13 Class AAA hospitals in China.

Positive Trial Results Lead to Early Termination of Enrolment

The primary endpoint of the trial is to improve the Ishak score of liver fibrosis by at least one grade. The IDMC’s recent review of interim results found that F351 demonstrated a generally favourable safety profile, with the best efficacy observed in patients receiving a 270 mg/day dose. The committee recommended that the trial continue with the remaining 36 patients through the 52-week treatment period before it concludes.

GNI Group stated that the IDMC’s recommendation marks a significant positive development for the company, its shareholders, and liver fibrosis patients. The trial is expected to be completed by mid-2019, with final results to be presented to the international scientific community.

Future Directions and Phase 3 Trial Preparation

Looking ahead, GNI Group plans to initiate preparations for a Phase 3 clinical trial of F351 in China and review data from a Phase 1 trial conducted in the United States. F351, a novel chemical entity derived from Etuary, targets hepatic stellate cell proliferation and the TGF-β signaling pathway—both of which are implicated in fibrosis of internal organs.

  China, Etuary, F351, GNI Group, Hepatitis B, IDMC, Liver fibrosis, Phase 2 trial, phase 3 trial, US clinical trial