Eiger BioPharmaceuticals Publishes Clinical Results of Lonafarnib in Hepatitis Delta Virus

Eiger BioPharmaceuticals Publishes Clinical Results of Lonafarnib in Hepatitis Delta Virus

Eiger BioPharmaceuticals Incorporated, a privately held biotechnology company focused on the research, development and commercialization of innovative therapies in viral hepatitis, recently announced their latest data on the first Phase 2a clinical trial examining lonafarnib in patients suffering with chronic hepatitis delta virus (HDV) infection.

Lonafarnib is a late-stage, orally active inhibitor of farnesyl transferase, an enzyme involved in the modification of proteins through a process called prenylation.

The double-blinded, dose ascending, placebo-controlled, randomized, clinical trial was conducted at the National Institutes of Health (NIH) Clinical Center in Bethesda, Maryland, and assessed two doses of lonafarnib, 100 mg twice per day and 200 mg twice per day for a period of 28 days in HDV patients.

“The NIH Clinical Center has completed a study with significant implications for treatment of chronic hepatitis D, which often leads to cirrhosis and other life-threatening conditions,” said in a recent news release Theo Heller, MD, Principal Investigator at the National Institute of Diabetes and Digestive and Kidney Diseases, part of the NIH.  “We are proud to have the results of this study published in The Lancet Infectious Diseases.”

After lonafarnib treatment the results revealed a reduction in the levels of viral HDV RNA for 28 days when compared to placebo, and a dose-dependent difference in the decline of viral HDV RNA between 200 mg twice daily and 100 mg twice daily doses when compared to placebo.

There was a correlation between the decline in viral HDV RNA levels and the levels of serum lonafarnib, validating the antiviral activity of lonafarnib in patients with chronic HDV.

Results from the trial also showed that lonafarnib was well tolerated, and the most frequent adverse sides events were gastrointestinal related.

“This is the first study evaluating lonafarnib, an oral therapy, in patients infected with HDV, and we are very pleased with the results,” said David Cory, President and Chief Executive Officer of Eiger. “HDV is the most severe form of human viral hepatitis.  Our goal is cure.”

Hepatitis D virus (HDV) is found only in people who carry the hepatitis B virus. HDV may make liver disease worse in people who have either recent (acute) or long-term (chronic) hepatitis B. It can even cause symptoms in people who carry hepatitis B virus but who never had symptoms. Hepatitis D infects about 15 million people worldwide and occurs in a small number of people who carry hepatitis B.

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