Eiger bags FDA breakthrough therapy status for HDV drug candidate Lambda

US biopharma company Eiger BioPharmaceuticals said that peginterferon lambda (Lambda) has been granted breakthrough therapy designation from the US Food and Drug Administration (FDA) for the treatment of hepatitis delta virus (HDV) infection.

Breakthrough therapy designation enables expedition of the development and review of drugs intended for the treatment of a serious condition and where initial clinical evidence suggests that the drug could deliver substantial improvement over available therapy on a clinically significant endpoint(s).

Eiger’s application was backed by data from a phase 2 clinical trial called LIMT Lambda monotherapy study in 33 patients infected with the hepatitis delta virus.

According to Eiger, Lambda is a type III interferon, which is being developed for the treatment of HDV – considered to be the most severe form of human viral hepatitis. Currently, there is no approved therapy for HDV.

David Cory – President and CEO of Eiger said: “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).”

Lambda has been designed to trigger immune responses that are essential for the development of host protection during viral infections. The investigational HDV drug targets type III IFN receptors which are completely different from the type I IFN receptors targeted by IFN alfa.

The type III receptors are highly expressed on hepatocytes having limited expression on hematopoietic and central nervous system cells, which could bring down off-target effects and boost tolerability of Lambda.

Although the investigational HDV drug from Eiger does not use the IFN alfa receptor, signaling through the IFN Lambda or IFN alfa receptor complexes leads to the stimulation of the same Jak-STAT signal transduction cascade.

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