Enrollment complete for phase 2 trial of Sarasar/ritonavir for HDV

Eiger BioPharmaceuticals, Inc. announced it has completed enrollment for a phase 2 clinical trial investigating a combination regimen of Sarasar and ritonavir for the treatment of hepatitis delta virus infection, according to a press release.

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.

“We are very pleased to conduct our first study with lonafarnib combined with ritonavir in HDV-infected patients,” Heiner Wedemeyer, MD, of the department of gastroenterology, hepatology and endocrinology, Hannover Medical School, Germany, said in the release. “Many drugs are dose-escalated or titrated to allow patients to acclimate to therapy and optimize treatment. The LOWR HDV-4 protocol design enables us to investigate the efficacy and tolerability of lonafarnib in combination with ritonavir in HDV-infected patients with an option to dose escalate or titrate at pre-specified times during the 24-week dosing period.”

Eduardo Martins, MD, DPhil, senior vice president of liver and infectious diseases drug development at Eiger, said in the release: “Hepatitis delta causes the most aggressive form of human viral hepatitis, with fast progression to cirrhosis and other life-threatening complications, and is a major health burden all over the world … [the study] is designed to help elucidate the antiviral potential of lonafarnib in combination with ritonavir in a longer duration study … we eagerly await results.”

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 of Wedemeyer at the time of publication. Martins is employed by Eiger.