Ribo Achieves Significant Milestone with EMA's Orphan Drug Designation for RBD1016 to Treat Hepatitis Delta Virus

Ribo Achieves EMA Orphan Drug Designation for RBD1016

Suzhou Ribo Life Science Co., Ltd. and Ribocure Pharmaceuticals AB, collectively known as Ribo, have exciting news to share as they announce that the European Medicines Agency (EMA) has granted the Orphan Drug Designation (ODD) to their therapeutic siRNA candidate, RBD1016. This designation is a crucial step forward for the treatment of Hepatitis Delta Virus (HDV) infection.

What Is Orphan Drug Designation?

The ODD from the EMA is specifically assigned to therapies under development for rare diseases that affect fewer than five individuals per 10,000 in the European Union. This classification provides significant regulatory and commercial incentives, which can significantly expedite the progression of the drug through the development process. Orphan designations are especially critical for diseases that are often overlooked due to their rarity.

RBD1016: A Promising New Therapy

RBD1016 utilizes Ribo's advanced RNA interference technology, specifically their proprietary RiboGalSTART™ platform. This approach is designed to selectively silence the key viral factors implicated in HDV infection. The current clinical framework focuses on validating RBD1016's efficacy in a global Phase II clinical trial.

Dr. Li-Ming Gan, Co-CEO and Global Head of R&D at Ribo, voiced the importance of this milestone, saying, "This designation represents a significant regulatory achievement that enhances RBD1016's development potential. It validates our commitment to addressing severe diseases with high unmet demands through innovative RNA interference technology. We aim to bring this promising therapy into clinical use and provide hope to patients suffering from this rare but serious condition."

Understanding Hepatitis Delta Virus (HDV)

The HDV is recognized as the most severe form of viral hepatitis. It only infects individuals who are also co-infected with the Hepatitis B Virus (HBV). The implication is dire; HDV accelerates liver disease progression, significantly heightening the risk of cirrhosis, liver failure, and hepatocellular carcinoma. Globally, it is estimated that between 12 and 20 million individuals are affected by HDV, yet therapeutic options remain limited.

Despite its severity, HDV is frequently underdiagnosed and neglected, highlighting the pressing need for targeted therapies like RBD1016. Ribo’s commitment to developing treatments specifically targeting HDV serves as a beacon of hope for both patients and healthcare professionals seeking more effective and lasting therapeutic solutions.

About Ribo

Founded in China, Suzhou Ribo Life Science Co. Ltd. is at the forefront of advancing small interfering RNA (siRNA) technology and the industrialization of oligonucleotide drugs. Ribo has built an integrated global drug development system and a comprehensive siRNA production line. Ribocure Pharmaceuticals AB operates out of Gothenburg, Sweden, and serves as Ribo's international R&D hub. Together, they are dedicated to pushing the boundaries of what RNA therapies can accomplish in the world of medicine.

For more information about their pioneering work, please visit www.ribolia.com and www.ribocure.com.