Fujian Cosunter Pharmaceutical Co., Ltd (SHE: 300436), a Chinese pharmaceutical company, has announced the successful conclusion of a Phase II clinical study for its hepatitis B virus (HBV) therapy, GST-HG141, in patients with chronic HBV and low viremia. The study demonstrated the drug’s potential in suppressing HBV DNA, a key indicator in managing the disease.
In the Phase II trial, 90 patients were enrolled, and various doses of GST-HG141 exhibited notable suppression effects on HBV DNA. After 24 weeks of treatment with GST-HG141 in combination with nucleoside analogues, the detection rate of HBV DNA below the limit was significantly higher in the high and low dose groups, at 81.5% and 84.0% respectively, compared to the use of nucleoside analogues alone, which was 32.1%. The treatment’s efficacy remained stable without significant fluctuations. Additionally, the reduction in both HBV DNA and pgRNA exceeded 1log10, further validating GST-HG141’s unique role in inhibiting HBV replication and depleting covalently closed circular DNA (cccDNA).
GST-HG141 is classified as a Category 1 innovative drug, targeting multiple key elements in the HBV replication process. Its ability to disrupt the establishment of the cccDNA virus pool and significantly reduce serum HBV-DNA levels positions it as a promising candidate in the treatment of chronic hepatitis B.- Flcube.com