China-based Fujian Cosunter Pharmaceutical Co., Ltd (SHE: 300436) has announced the first patient enrollment and dosing in a Phase II clinical study for its hepatitis B virus (HBV) therapy GST-HG141. This marks a significant step in the development of innovative treatments for chronic hepatitis B.
GST-HG141: Innovative Drug for HBV
GST-HG141 is a Category 1 innovative drug that targets several key factors involved in HBV replication. The drug is designed to destroy the establishment of the covalently closed circular DNA (cccDNA) virus pool and significantly reduce serum HBV-DNA levels. This mechanism of action offers a potential breakthrough in the treatment of chronic HBV infections.
Phase I Clinical Study Results
In a Phase I clinical study, GST-HG141 was found to be well-tolerated and safe in patients with chronic HBV (cHBV), with a good pharmacokinetics profile. These results provide a strong foundation for the advancement of the drug into Phase II trials.
Phase II Clinical Study Design
The randomized, double-blind, placebo-controlled, multi-center Phase II clinical study is designed to assess the efficacy and safety of GST-HG141 with different dosages in treated cHBV patients. The study aims to recommend protocol design and dosage for Phase III clinical trials, bringing the drug one step closer to potential market approval.-Fineline Info & Tech
