April 29, 2016
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Eiger licenses lambda to investigate potential therapy for hepatitis delta

Eiger BioPharmaceuticals Inc. announced it licensed pegylated interferon lambda-1a to Bristol-Myers Squibb to investigate the efficacy and safety of the drug as a therapeutic option for the treatment of hepatitis delta virus infection.

Eiger plans to evaluate lambda, a type 3 interferon, as a potential monotherapy and combination regimen for individuals with chronic hepatitis delta virus (HDV) infection. To date, pegylated interferon lambda-1a has been studied in more than 3,000 patients with hepatitis delta infection. It is not approved for any indication, according to a press release.

“Most cells in the body express the receptor for interferon alfa, a type 1 interferon. However, receptors for lambda, a type 3 interferon, are expressed on liver cells, a desirable location for treating viral hepatitis, but less so on some blood cells and non-liver cells,” Eduardo Martins, MD, DPhil, senior vice president of liver and infectious disease at Eiger, said in the release. “Lambda represents a promising and potentially better tolerated interferon therapy for HDV.”

In January, Eiger initiated a phase 2 dose titration study, known as LOWR HDV-4, designed to investigate the efficacy and tolerability of Sarasar (lonafarnib, Eiger), its inhibitor of farnesyl transferase, combined with ritonavir for HDV. Fifteen patients will receive the combination regimen daily for 24 weeks.

In a previous phase 2A, placebo-controlled trial, Christopher Koh, MD, staff clinician, Liver Diseases Virology Section, Liver Diseases Branch of the National Institutes of Health National Institute of Diabetes and Digestive and Kidney Diseases, and colleagues found that treatment with lonafarnib over 4 weeks reduced chronic hepatitis delta virus RNA.

The FDA and European Medicines Agency granted Eiger BioPharmaceuticals orphan drug designation for lonafarnib in December 2014.

“There is no approved therapy for HDV,” David Cory, president and CEO of Eiger, said in a press release. “Along with lonafarnib, our phase 2 candidate for the treatment of HDV, Eiger has established a strategic position with the addition of lambda. … We are very excited to execute this license with Bristol-Myers Squibb.”

Disclosure: Cory and Martins are employed by Eiger BioPharmaceuticals.