China-based Fujian Cosunter Pharmaceutical Co., Ltd (SHE: 300436) has announced the receipt of ethical approval from the Chinese PLA General Hospital to commence a randomized, double-blind, placebo-controlled Phase IIa clinical study. The study will assess the safety and efficacy of GST-HG131, which the company describes as a first-in-class hepatitis B surface antigen (HBsAg) inhibitor.
Mechanism of GST-HG131
GST-HG131 is an oral small-molecule HBsAg inhibitor designed to destabilize and degrade HBV mRNA. This action blocks the expression of HBV mRNA, effectively inhibiting the synthesis of surface antigen. The unique mechanism of GST-HG131 offers therapeutic benefits across various virological indicators, marking a potential advancement in the treatment of hepatitis B.
Clinical Trial Progress and Safety Profile
In animal in vivo pharmacological experiments, GST-HG131 has demonstrated a significant inhibitory effect on HBsAg. Additionally, the completed Phase Ia clinical trial has shown good overall safety, paving the way for the upcoming Phase IIa study. This trial will be crucial in further evaluating the drug’s safety and efficacy in human subjects, bringing the potential for a new treatment option for hepatitis B patients.-Fineline Info & Tech
