Eiger BioPharmaceuticals has filed an investigational new drug (IND) application with the U.S. Food and Drug Administration (FDA) for Lambda (pegylated interferon lambda 1a) as a treatment for the hepatitis delta virus (HDV).
In addition, a series of clinical trial sites worldwide have started enrolling patients for a Phase 2 LIMT open-label trial (NCT02765802) evaluating 120- or 180-microgram injections of Lambda to treat chronic HDV infection. HDV is also known as hepatitis D.
The therapy will be administered weekly for 48 weeks in 30 to 40 patients with chronic HDV. After the 48 weeks, patients will move to a treatment-free 24-week observation period.
The primary objective of the trial is to assess the safety, tolerability and effectiveness of two doses of Lambda.
HDV is one of the most severe forms of viral hepatitis. Hepatitis delta develops as a co-infection in patients already harboring the hepatitis B virus (HBV), which is why treatment for HBV will be given in parallel to all trial participants.
Hepatitis delta leads to more severe liver disease than HBV alone and is linked to accelerated damage in the liver, including fibrosis, cancer and failure.
“Over recent years, patients with chronic hepatitis B and hepatitis C have benefited from huge advances in antiviral therapy for both diseases. Unfortunately HDV remains a large unmet medical need because of the lack of any effective therapy for this most aggressive form of viral hepatitis. In many countries, HDV presents a real public health challenge,” Dr. Eduardo Martins, senior vice president of liver and infectious diseases development at Eiger, said in a press release.
Lambda is a late-stage type 3 interferon (IFN) that stimulates immune responses essential to the development of host protection during viral infections. Lambda targets type 3 IFN receptors. Other IFN alfa therapies target type 1 IFN receptors.
Because of type 2 IFN receptors’ characteristics, Lambda reduces off-target effects associated with other IFNs, and patients tolerate it better. Lambda has yet to receive regulatory approval, however.
“This filing should facilitate discussions with the agency regarding potential Lambda development and registration pathways for HDV as well as expanding the program to U.S. investigators and U.S. patients,” said Dr. Shelly Xiong, senior vice president of regulatory affairs at Eiger.
At the moment, trial sites in New Zealand, Israel and Pakistan are enrolling participants. For more information on the sites and participation criteria, please contact Isabel Gorham at 650-272-6138 or [email protected].
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