Ribo Life Science's siRNA Drug RBD1016 Granted IND Approval in China for Chronic Hepatitis B

Oct 24, 2024 08:37 CST Updated 08:37

Ribo Life Science

Small Nucleic Acid Drug Developer

Recently, the official website of the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) announced that SuzhouRibo Life ScienceTechnology Co., Ltd.(hereinafter referred to as "Ribo Life Science")RBD1016 Injection Granted Clinical Trial Approval, Indication forChronic Hepatitis B Virus（HBV）Infection.

▲ Image Source: CDE Official Website

RBD1016 Injection is an investigational siRNA drug developed by Ribo Life Science for the treatment of chronic hepatitis B.The drug adopts N-acetylgalactosamine (GalNAc) delivery technology,Targeting the conserved region of the X gene in Hepatitis B Virus (HBV),Through the RNA interference mechanism, it inhibits all four transcripts of HBV, with the ability to simultaneously suppress HBV DNA replication, reduce cccDNA and HBsAg derived from integrated DNA, and decrease other antigens.

Previously, RBD1016 underwent Phase I and Phase II clinical trials in Australia and Europe, respectively.。The pharmacodynamic data from the Phase Ib clinical trial of RBD1016 for the treatment of chronic hepatitis B have shown,RBD1016 demonstrated consistent inhibitory effects on HBsAg, HBV DNA, HBV RNA, and HBcrAg.The specific research data are as follows:

During the study period,The decreasing trend of HBsAg continued until the 24th week at the end of the study.The average maximum reduction in serum HBsAg from baseline across all dose groups was as follows: For all subjects receiving RBD1016 at doses of 1mg/kg and 3mg/kg, the minimum decrease in serum HBsAg from baseline exceeded 0.5 log.₁₀IU/mL。

In addition, three subjects who were HBV DNA positive at baseline reached the endpoint at weeks 1, 3, and 12, respectively.Undetectable serum HBV DNA status（<10 IU/ml）。

At the same time, at baseline, a total of 12 subjects treated with RBD1016 were positive for serum HBV RNA.(Lower Limit of Quantitation: 10 copies/mL), the average HBV RNA value of these positive subjects was 3.15 log₁₀copies/mL. However, by the 24th week,The HBV RNA levels of these subjects significantly decreased,The average value dropped to 2.52 log₁₀ copies/mL。

In addition, there were three subjectsThe level of HBV RNA decreased to an undetectable level.(Subjects received 0.3mg/kg SD respectively, baseline 1.49 log₁₀copies/mL; 1mg/kg SD dose, baseline 1.04 log₁₀copies/mL; and 3mg/kg MD, baseline 2.29 log₁₀ copies/mL）。

Finally, the HBcrAg decline data showed that the 3mg/kg MD dose group produced the largest reduction, with a maximum decline of 0.62 log.₁₀ U/mL(Appeared in Week 12)。

E.N.D

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Disclaimer: The content is sourced from Ribo Life Science, the CDE official website, and Yimaike, among other sources. This article aims to share knowledge, and all content is for reference only and does not constitute any recommendations.