Hepatitis D Virus Trial Commences

A new trial investigates the use of Lambda in patients with hepatitis D virus.

Eiger Biopharmaceuticals recently started dosing patients with chronic hepatitis D virus (HDV) in a phase 2 clinical trial of Lambda (pegylated interferon lambda 1a).

“We are excited to begin dosing HDV-infected patients with Lambda in the LIMT HDV study,” said Eduardo Martins, MD, DPhil, senior vice president of Liver and Infectious Diseases Drug Development at Eiger. “We plan to explore Lambda alone and in combination with lonafarnib, our lead compound in Phase 2 development to treat HDV. Eiger now has multiple active anti-HDV agents in development, including an oral therapy and a subcutaneous injectable therapy to study alone and in combination toward the suppression or cure of HDV.”

In the LIMT HDV trial, patients were randomized 1:1 to receive Lambda 120 or 180 microgram subcutaneous injections for 48 weeks. After 48 weeks, patients will be observed for another 24 weeks, according to a press release from Eiger.

Patients will also receive an anti-hepatitis B virus neucleos(t)ide analog during the treatment period. The primary endpoint is to evaluate each of the doses in terms of safety, tolerability, and efficacy.

Lambda is a type 3 interferon that elicits immune responses needed to protect patients from viral infections, such as HDV. This drug targets the type 3 interferon receptors, which are highly expressed on liver cells, but have small expression on hematopoietic and central nervous system cells.

Other treatments, such as interferon alfa target type 1 interferon receptors. Signaling through the interferon lambda or interferon alfa receptor results in the activation of the same Jak-STAT signal transduction cascade, according to Eiger.

Lambda has been investigated in clinical trials that include more than 3000 patients, but it has not yet received FDA approval for any indication.

Because hepatitis D only occurs in patients with hepatitis B virus, it is the most severe form of hepatitis. Prevalence of HDV varies worldwide, and is seen in as many as 60% of patients with hepatitis B in Mongolia and Pakistan, Eiger said.

“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 huge 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,” said principal investigator Edward Gane, MD. “We are delighted to have enrolled the first patient in LIMT HDV, a study that may lay the groundwork for development of Lambda in HDV infection.”