Suzhou Ribo Life Science Ltd, “Ribo”, announces EMA authorisation to proceed with a Phase II clinical trial in Sweden. The trial will evaluate the efficacy and safety of its novel siRNA asset RBD1016, for the treatment of the rare disease of chronic hepatitis D infection.

Suzhou Ribo Life Science Ltd., and its international research center in Sweden, Ribocure Pharmaceuticals AB, are determined to deliver cutting-edge siRNA therapeutics to patients all over the world. This authorisation marks Ribo dedication to potentially treat not only HBV infected patients, but also patients infected with HDV. HDV is the most severe form of chronic viral hepatitis, associated with a high risk for developing liver cirrhosis and subsequentially hepatocellular carcinoma.

The hepatitis D virus (HDV) is an RNA virus which requires the presence of hepatitis B virus (HBV) to propagate and cause infection. Globally, HDV affects approximately 5 % of people living with chronic HBV. Hence, it is commonly referred to as a satellite virus because it cannot propagate without the assistance of HBV.

RBD1016 has shown high potency and durability in a Ph1b study in hepatitis B infected patients. In addition, data from nonclinical studies clearly supports that RBD1016 has the potential to optimize the field of HDV treatment by offering a safe and effective alternative to currently available therapies.

“Developing siRNA drugs to address unmet medical needs for global patients is at the core of Ribo's global strategy. The clinical approval of RBD1016 for HDV indication marks an important step forward in providing innovative RNAi therapies for rare disease patients worldwide. As we progress with our globalization and diversified research and development strategies, we aim to rapidly advance more innovative siRNA drugs into clinical and commercial stages, striving to offer improved treatment options for global patients as quickly as possible.” says Zicai Liang, CEO Suzhou Ribo Life Science Ltd.