Liver (National Library of Medicine)
22 December 2014. An intermediate-stage clinical trial testing a biologic treatment made by Eiger BioPharmaceuticals Inc. shows lower hepatitis D virus levels among patients taking the treatment compared to a placebo. The San Carlos, California company says the treatment, called lonafarnib, also received orphan drug status by regulatory authorities in the U.S. and Europe.
Hepatitis D, also known as delta hepatitis, is a rare type of liver disease caused by defective RNA that requires help from hepatitis B to replicate. Thus, hepatitis D only infects people already infected with hepatitis B. The disease is spread through sexual contact, infected blood products, or shared syringes. People not immunized against hepatitis B are at risk for hepatitis D. If left untreated, hepatitis D can lead to cirrhosis, liver cancer, and liver failure.
Lonafarnib inhibits the activity of enzymes that modify proteins encouraging replication of hepatitis D viruses in the liver, and as a result, blocks the ability of viruses to multiply. Eiger is also developing a similar biologic, code-named EBP921, that inhibits the same protein-modifying enzymes, but in preclinical tests blocks formation of hepatitis D virus particles.
The clinical trial, conducted by National Institutes of Health at its facilities in Bethesda, Maryland, is enrolling 14 patients with chronic hepatitis D. Patients are randomly assigned to receive lonafarnib or a placebo twice a day for 28 days, in doses of 100 or 200 milligrams. The main effectiveness measure in the trial is level of hepatitis D virus RNA in the blood, but the trial is also tracking levels of an enzyme indicator of liver damage and side effects from treatments.
The results of the trial, reported at a meeting of American Association for the Study of Liver Diseases, shows patients taking lonafarnib had lower levels of hepatitis D virus RNA compared to patients receiving a placebo. The researchers also report lower levels of hepatitis D virus RNA when patients take higher doses of lonafarnib. In addition, patients reported lonafarnib was well tolerated with the most common adverse effects being gastrointestinal in nature.
Eiger reports as well that lonafarnib received orphan drug designation from the U.S. Food and Drug Administration and European Medicines Agency. Orphan drug designation from FDA is granted to treatments being developed for diseases affecting fewer than 200,000 people in the U.S. Therapies, both drugs and biologics, designated as orphan drugs qualify for incentives such as tax credits for clinical trials and exemptions from marketing application fees.
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