Therapy Areas: Central Nervous System
FDA Grants Orphan Drug Designation to Eiger for Lambda Interferon as Potential Treatment of Hepatitis Delta Virus Infection
6 September 2017 - - Palo Alto, California-based rare disease therapeutics developer Eiger BioPharmaceuticals, Inc. (NASDAQ: EIGR) has been granted orphan drug designation by the US Food and Drug Administration for pegylated interferon lambda 1a (Lambda) as a potential treatment for chronic hepatitis delta virus (HDV) infection, the company said.
Lambda, a well-characterized, late-stage, first in class, type III interferon that stimulates immune responses critical for the development of host protection during viral infections, targets.
These type III receptors are highly expressed on hepatocytes with limited expression on hematopoietic and central nervous system cells, which may reduce off-target effects and improve tolerability of Lambda.
Type III IFN receptors are distinct from the type I IFN receptors targeted by IFN alfa. Although Lambda does not use the IFN alfa receptor, signaling through either the IFN Lambda or IFN alfa receptor complexes results in the activation of the same Jak-STAT signal transduction cascade.
Hepatitis Delta, caused by infection with HDV, is considered to be one of the most severe forms of viral hepatitis in humans. It occurs only as a co-infection in individuals harboring Hepatitis B Virus (HBV).
Hepatitis delta leads to more severe liver disease than HBV alone and is associated with accelerated liver fibrosis, liver cancer, and liver failure. It may affect up to approximately 15-20 million people worldwide.
Eiger is a clinical-stage biopharmaceutical company focused on the development and commercialization of targeted therapies for orphan diseases. Through the repurposing of drugs for orphan diseases, the company's mission is to systematically reduce the time and cost of the drug development process to more rapidly deliver important medicines to patients.