Eiger BioPharmaceuticals has dosed the first patient in a Phase 2 clinical trial evaluating Lambda (pegylated interferon lambda 1a) monotherapy for the treatment of chronic hepatitis delta virus (HDV) infection.
Lambda is a late-stage, first-in-class, type III interferon that stimulates cell-mediated immune responses that are critical for the development of host protection during viral infections.
The randomized, open-label Phase 2 clinical trial, LIMT HDV (NCT02765802), is assessing the safety and tolerability of treatment with Lambda 120 or 180 μg subcutaneous injection, over a 48-week treatment period, in 30 patients with HDV infection. The trial is currently enrolling participants at the University of Auckland in New Zealand with additional sites planned in Israel and Pakistan. The trial’s primary endpoint is the change from baseline in HDV viral load.
“We are excited to begin dosing HDV-infected patients with Lambda in the LIMT HDV study,” Eduardo Martins, MD, PhD, senior vice president of Liver and Infectious Diseases Drug Development at Eiger, said in a press release. “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,” Martins said.
Hepatitis Delta, aka hepatitis D, is the most severe form of viral hepatitis in humans and is caused by infection with HDV. HDV is considered to be a sub-viral satellite, because it can propagate only in the presence of the hepatitis B virus (HBV). Transmission of HDV can occur either via simultaneous infection with HBV (co-infection) or superimposed on chronic hepatitis B or hepatitis B carrier state (superinfection). HDV has currently no approved therapies, and the disease has a significant impact on global health, affecting 15-20 million people worldwide.
“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,” concluded Edward Gane, MD, principal investigator and professor of medicine at University of Auckland. Gane also is chief hepatologist, transplant physician and deputy director of the New Zealand Liver Transplant Unit at Auckland City Hospital. “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,” he said.