The Chinese drug clinical trial registration and information disclosure platform shows that Dongyang Sunshine Pharmaceuticals and Guangdong South China New Drug Innovation Center have launched a phase 3a clinical trial to evaluate the combination of mofexidine mesylate capsules/ritonavir tablets and nucleoside drugs Compared with nucleoside drugs, the effectiveness and safety in subjects with chronic hepatitis B (CHB).

Public information shows that Murfixidine Mesylate Capsules (GLS4) is a hepatitis B virus (HBV) nucleocapsid protein assembly inhibitor developed by Dongyang Sunshine Pharmaceuticals, a subsidiary of Dongyang Sunshine Pharmaceuticals. It has been used in monotherapy and The combination therapy showed effective antiviral activity.

According to reports in the literature, mofexidine is structurally a dihydropyrimidine drug, which is a targeted HBV nucleocapsid protein assembly inhibitor according to its mechanism of action. It acts on the assembly process of virus core particles, which can reduce the correct assembly of virus capsids in a dose-dependent manner and accelerate the formation of abnormal capsids.

HBV is an enveloped virus. The envelope is formed by three kinds of surface proteins that wrap the virus nucleocapsid, which are the large surface protein of HBV, the medium surface protein of HBV, and the small surface protein of HBV. The nucleocapsid protein assembly inhibitor inhibits HBV DNA replication, interferes with the correct assembly of the virus capsid, forms an incorrect three-dimensional structure, reduces the amount of the virus capsid and core protein dimers, and strongly inhibits the replication and maturation of HBV The production of virus particles.

The launch in China this time is a phase 3a clinical trial of a combination of nucleoside drugs and nucleoside drugs compared with mofexidine mesylate capsules/ritonavir tablets (RTV). The main investigator of the study is Professor Niu Junqi from the First Hospital of Jilin University, who plans to enroll 210 people in China. The primary endpoints of the study included: HBV DNA at the completion of 48 weeks of treatment in the entire population, and HBV DNA at the completion of 48 weeks of treatment in the HBeAg-positive and negative populations.

This article comes from the Internet, if it violates your rights, please contact to delete it, thank you