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Eiger initiates phase 2 trial of lonafarnib/ritonavir for HDV

Eiger BioPharmaceuticals, Inc. announced it has dosed its first patient in its phase 2 clinical trial investigating a combination regimen of Sarasar and ritonavir for the treatment of hepatitis delta virus infection.

The trial, known as LOWR HDV-4, is a dose titration study designed to investigate the efficacy and tolerability of Sarasar (lonafarnib, Eiger), an inhibitor of farnesyl transferase, combined with ritonavir. Fifteen patients with HDV will receive the combination regimen daily for 24 weeks, according to a press release.

“We are very pleased to participate in our first Phase 2 study involving lonafarnib in hepatitis delta-infected patients,” Heiner Wedemeyer, MD, principal investigator, and of the department of gastroenterology, hepatology and endocrinology, Hannover Medical School, Germany, said in the release. “We are committed to advancing research and to identifying effective therapeutic options for patients infected with HDV, the most aggressive form of chronic viral hepatitis.”

In a previous phase 2a clinical trial, researchers evaluated two doses of lonafarnib, 100 mg twice daily and 200 mg twice daily for 28 days, and found that HDV RNA viral levels correlated with serum lonafarnib drug levels.

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

Disclosure: Healio.com/Hepatology was unable to confirm relevant financial disclosures at the time of publication.