Ribo Receives EMA Orphan Drug Status for RBD1016 Against Hepatitis D Infection

Ribo's New Milestone in Hepatitis D Treatment

In a significant advancement for biotechnology, Suzhou Ribo Life Science Co., Ltd., along with its partner Ribocure Pharmaceuticals AB, has recently announced that the European Medicines Agency (EMA) has granted Orphan Drug Designation (ODD) to their innovative siRNA therapeutic, RBD1016. This breakthrough marks a critical step in the fight against Hepatitis Delta Virus (HDV), a condition threatening millions and renowned for its severity.

Understanding Hepatitis D Virus (HDV)

Hepatitis D is often considered the most dangerous form of viral hepatitis as it only afflicts patients who are co-infected with the hepatitis B virus (HBV). The presence of HDV accelerates liver damage, increasing the risks of cirrhosis, liver failure, and hepatocellular carcinoma. Globally, it's estimated that between 12 to 20 million people are living with HDV. Unfortunately, current therapeutic options are scarce, leaving many patients vulnerable and without effective treatments.

Despite its impact, HDV remains underdiagnosed, with a considerable gap in available treatment options. The introduction of targeted therapies like RBD1016 is crucial and could provide a hopeful avenue for patients relying on improved management of their condition.

The Significance of Orphan Drug Designation

The EMA's Orphan Drug Designation for RBD1016 is not merely a formality; it represents a crucial regulatory and commercial advantage for development. This classification applies to therapies for rare diseases that affect fewer than five out of 10,000 people within the European Union. Such a designation accelerates the therapeutic's journey toward market readiness and offers various benefits, including tax credits, market exclusivity for a defined period, and a more streamlined development process.

Dr. Li-Ming Gan, Co-CEO and Global Head of R&D at Ribo, highlighted this development as a substantial regulatory achievement, emphasizing that it not only enhances the commercial potential of RBD1016 but also validates their approach of targeting diseases with significant unmet medical needs. According to Dr. Gan, the use of innovative RNA interference (RNAi) technology aligns with Ribo's strategic goals.

RBD1016: Mechanism of Action

RBD1016 is tailored to leverage Ribo's proprietary GalNAc-platform RiboGalSTARTM, aiming to selectively silence critical viral factors responsible for HDV infections. Currently, this therapeutic's efficacy is undergoing rigorous evaluation in Phase II clinical trials globally. As the clinical studies progress, Ribo hopes to affirm the effectiveness of RBD1016, paving the way for an urgently needed treatment option for those suffering from HDV.

Closing the Gap in HDV Treatment

The potential impact of RBD1016 cannot be overstated. The ability to provide a viable treatment for a disease that has long been overlooked represents a beacon of hope for HDV patients. Ribo Life Science aims to navigate the clinical development pathway with diligence, hoping to bring this necessary therapy to market swiftly.

As Ribo continues its pioneering journey in RNAi technology and medicine, the emphasis remains on delivering breakthrough treatments that can address significant health challenges. For those affected by Hepatitis D, RBD1016 symbolizes not only scientific progress but a lifeline towards better health outcomes.

About Ribo Life Science

Founded in China, Suzhou Ribo Life Science Co., Ltd. stands at the forefront of RNAi technology and the industrialization of oligonucleotide drugs. The company has developed a comprehensive therapeutic platform integrating various technologies, thus positioning itself as a key player in the global drug development arena. In addition, Ribocure Pharmaceuticals AB serves as Ribo's international R&D hub located in Gothenburg, Sweden.

For further details, visit Ribo Life Science and Ribocure Pharmaceuticals.