"A phase II clinical study to evaluate the safety, efficacy, and pharmacokinetics of RBD1016 injection in participants with chronic hepatitis B" is currently ongoing in Sweden and Hong Kong, China.
RBD1016 is a GalNAc-siRNA being developed for treatment of hepatitis B. RBD1016 covers patient population with hepatitis B virus genotypes A-E and I, which represent the vast majority of hepatitis B patients in Europe, the United States and Asia. It has shown a highly efficient long-acting effect of reducing the HBsAg in serum and liver tissues in non-clinical studies. After a single treatment, inhibition of HBsAg lasted nearly 6 months. RBD1016 is the only anti-hepatitis B siRNA drug globally that demonstrated serological conversion in animal models, indicative of its BIC potential. RBD1016 has demonstrated well tolerated safety profile and pharmacokinetic characteristics expected for GalNAc-siRNA in clinical studies. Pharmacodynamic data on hepatitis B patients indicate that RBD1016 exhibits a relatively consistent and long-lasting inhibitory effect on HBsAg, HBV DNA, HBV RNA, and HBcrAg.
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