The Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to peginterferon lambda (Lambda; Eiger BioPharmaceuticals) for the treatment of hepatitis delta virus (HDV) infection.
Hepatitis D, an uncommon but severe form of viral hepatitis, only occurs in individuals infected with the hepatitis B virus (HBV). Infection with HDV can lead to more severe liver disease than HBV alone and is associated with rapid hepatic fibrosis, carcinoma, and decompensation.
Lambda is a late-stage, first-in-class, type 3 interferon (IFN) that stimulates cell-mediated immune responses. It targets type 3 IFN receptors that are highly expressed on hepatocytes with limited expression on hematopoietic and CNS cells. Currently, there is no approved therapy for HDV.
The FDA designation is supported by data from the phase 2 LIMT (Lambda Interferon MonoTherapy in Hepatitis Delta Virus) study which evaluated Lambda monotherapy in 33 patients with chronic HDV for 48 weeks with a 24 week follow-up. Results showed that 36% of Lambda-treated patients acheived HDV-RNA below the limit of quantification, comparable to historical peginterferon alfa at week 48; a durable virologic response was achieved in 36% of patients 24 weeks post-treatment.
Regarding safety, the most common treatment-emergent adverse events included mild to moderate flu-like symptoms and elevated transaminase levels.
“We look forward to continued collaboration with the FDA, now on four Breakthrough Therapy Designation programs including both Lonafarnib and Lambda for hepatitis delta virus (HDV) infection, Lonafarnib for Hutchinson-Gilford Progeria Syndrome (Progeria) and Progeroid Laminopathies, and Avexitide for post-bariatric hypoglycemia (PBH),” said David Cory, President and CEO of Eiger.
Lambda was previously granted Orphan Drug and Fast Track designation by the FDA.
For more information visit eigerbio.com.