RBD1016 / Suzhou Ribo - LARVOL DELTA

A Study of RBD1016 in CHB Participants (clinicaltrials.gov) - P2 | N=48 | Completed | Sponsor: Suzhou Ribo Life Science Co. Ltd. | Active, not recruiting ➔ Completed

Trial completion • Hepatitis B • Infectious Disease • Inflammation

Ribo Granted EMA Orphan Drug Designation for siRNA Therapeutic RBD1016 for Hepatitis Delta Virus (HDV) Infection (PRNewswire) - "Efficacy of RBD1016 is currently being assessed in global Phase II clinical development."

Orphan drug • Infectious Disease

A potent GalNAc-siRNA drug, RBD1016, leads to sustained HBsAg reduction and seroconversion in mouse models of HBV infection. (PubMed, Mol Ther Nucleic Acids) - "Furthermore, the combination of RBD1016 and entecavir (ETV) demonstrated an enhanced effect on serum HBV DNA inhibition. A strong and durable anti-HBV effect of RBD1016, both alone and in combination with nucleoside analogues (NAs), indicates significant therapeutic potential for chronic hepatitis B (CHB) patients."

Journal • Preclinical • Hepatitis B • Infectious Disease • Inflammation

A Study of RBD1016 in CHB Participants (clinicaltrials.gov) - P2 | N=48 | Active, not recruiting | Sponsor: Suzhou Ribo Life Science Co. Ltd. | Recruiting ➔ Active, not recruiting | Trial completion date: Mar 2026 ➔ Dec 2025 | Trial primary completion date: Aug 2025 ➔ Apr 2025

Enrollment closed • Trial completion date • Trial primary completion date • Hepatitis B • Hepatology • Infectious Disease • Inflammation

A Study of RBD1016 in CHB Participants (clinicaltrials.gov) - P2 | N=48 | Recruiting | Sponsor: Suzhou Ribo Life Science Co. Ltd. | N=104 ➔ 48

Enrollment change • Hepatitis B • Hepatology • Infectious Disease • Inflammation

Analysis of the pharmacokinetics and efficacy of RBD1016 - A GalNAc-siRNA targeting Hepatitis B Virus X gene using semi-mechanistic PK/PD model. (PubMed, Heliyon) - "Further PK and PD data for RBD1016, including clinical data, will assist in refining the model presented here. Our current effort focused on model building for RBD1016, we anticipate that the model could apply to other GalNAc-siRNA drugs."

Journal • PK/PD data • Hepatitis B • Hepatology • Infectious Disease • Inflammation

Metabolite identification and quantitation of RBD1016 siRNA: a direct comparison of hybridization-based LC-FD and LC-HRAM assays. (PubMed, Bioanalysis) - "The two methods were successfully bridged by analyzing the same sets of study samples. Results & Both methods were found to have excellent accuracy/precision, specificity and reproducibility to support ADME and PK/PD studies of RBD1016 siRNA."

Journal • Hepatitis B • Hepatology • Infectious Disease • Inflammation

A Single and Repeated Dose Escalation of RBD1016 in Subjects With Chronic Hepatitis B Virus (HBV) Infection (clinicaltrials.gov) - P1 | N=40 | Completed | Sponsor: Suzhou Ribo Life Science Co. Ltd. | Recruiting ➔ Completed | Trial completion date: May 2024 ➔ Oct 2023 | Trial primary completion date: Jun 2023 ➔ Oct 2023

Trial completion • Trial completion date • Trial primary completion date • Hepatitis B • Hepatology • Infectious Disease • Inflammation

A Study of RBD1016 in CHB Participants (clinicaltrials.gov) - P2 | N=104 | Recruiting | Sponsor: Suzhou Ribo Life Science Co. Ltd. | Not yet recruiting ➔ Recruiting

Enrollment open • Hepatitis B • Hepatology • Infectious Disease • Inflammation

A Study of RBD1016 in CHB Participants (clinicaltrials.gov) - P2 | N=104 | Not yet recruiting | Sponsor: Suzhou Ribo Life Science Co. Ltd.

New P2 trial • Hepatitis B • Hepatology • Infectious Disease • Inflammation

Safety and antiviral activity of RBD1016, a RNAi therapeutic, in chinese subjects with chronic hepatitis B virus (HBV) infection (EASL-ILC 2023) - P1 | " As of December 28, 2022, twenty-seven subjects (mean age 43.2 years, 44.4% male) (SD=20, MD=7) were enrolled, of which 26 (96.3%) were on NAs therapy (entecavir: 17, tenofovir disoprovil fumarate: 6; tenofovir alafenamide: 3) for a median duration of 54.5 (range: 16-150) months. A single dose of RBD1016 demonstrated a rapid and durable reduction in serum HBsAg in a dose-dependent manner. Multiple doses of RBD1016 showed increased reduction in HBsAg. Preliminary safety data suggested that RBD1016 was generally safe and well tolerated."

Clinical • Fibrosis • Hepatitis B • Hepatology • Infectious Disease • Inflammation