Ribocure Pharmaceuticals AB 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.
Ribocure Pharmaceuticals AB, the international research center of Suzhou Ribo Life Science Ltd, is determined to deliver cutting-edge siRNA therapeutics to patients all over the world. This authorisation marks Ribocure’s and Ribo’s 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.
“This study clearly marks an advancement of our rare disease portfolio with RNA-based treatment. I am personally impressed by the Ribocure team, in terms of their speed of pushing the program forward from idea to CTA approval, the demonstrated scientific rigor and agility, as well as the highly professional collaborative spirit among the team members.” says Li-ming Gan, CEO Ribocure Pharmaceuticals AB.
