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SuzhouRibo Life Science Co., Ltd. (referred to as "Ribo Life Science") announced that the Phase II clinical trial of its self-developed small nucleic acid drug RBD1016 injection for the treatment of Hepatitis Delta Virus (HDV) has been approved by the European Medicines Agency (EMA).This trial will evaluate RBD1016Efficacy and Safety of HDV Infection Treatment.HDV relies on the presence of HBV to replicate and cause infection, thus specifically infecting individuals with hepatitis B. Currently, about 5% of chronic hepatitis B patients are co-infected with HDV. HDV/HBV co-infection accelerates the progression of liver disease, increasing the incidence of cirrhosis and hepatocellular carcinoma several-fold in co-infected patients. At diagnosis, 30-70% of hepatitis D patients are already confirmed to have cirrhosis, and 50% of patients die within 10 years of diagnosis (JAMA . 2023 Dec 6;330(24):2376-2387). Therefore, hepatitis D is the most severe form of chronic viral hepatitis, with significant unmet clinical needs.
RBD1016 Demonstrates Significant Potency and Long-Lasting Effect in Suppressing Hepatitis B Surface Antigen (HBsAg) in the Completed Phase Ib Clinical Trial for Chronic Hepatitis B (HBV) Indication. In Another Preclinical Study, RBD1016 Shows Better Safety and Efficacy Potential Compared to Existing HDV Treatment Drugs.
Ribo Life Science is committed to providing cutting-edge siRNA therapies to patients worldwide. The recent clinical approval in the EU signifies that RBD1016 not only has the potential for functional cure of chronic hepatitis B but also may offer a novel treatment option for patients with Hepatitis Delta Virus (HDV).
Dr. Zicai Liang, Chairman and CEO of Ribo Life Science"Developing small nucleic acid drugs for unmet medical needs for patients worldwide is the core of Ribo Life Science's global strategy. The clinical approval of RBD1016 for HDV indication marks an important step in providing innovative RNAi therapies to patients with rare diseases globally. In advancing our global and differentiated R&D strategy, we will rapidly move more innovative small nucleic acid drugs into clinical and commercial stages, striving to offer better treatment options to patients worldwide as soon as possible."Suzhou Ribo Life Science Co., Ltd. (referred to as "Ribo Life Science") was established in 2007. It is an innovative R&D company dedicated to developing RNA interference (RNAi) drugs and is a major pioneer and leader in China's small nucleic acid technology and small nucleic acid pharmaceuticals industry. The company’s headquarters is located in Kunshan, Jiangsu, with R&D centers in Beijing and Gothenburg, Sweden.Ribo Life Science benchmarks the innovative frontier of international small nucleic acid technology, committing to the iterative R&D of small nucleic acid chemical modification and drug delivery technologies. It has established an independent, controllable, and fully integrated small nucleic acid drug R&D platform that supports the entire lifecycle of small nucleic acid drugs from early-stage R&D to industrialization. Its self-developed GalNAc small nucleic acid drug delivery technology platform, RIBO-GalSTARTM, exhibits internationally competitive levels of highly specific liver targeting, high efficiency, and long-lasting characteristics.Source: Ribo Life Science
