Dosing complete in LOWR HDV-4 phase 2 study

Eiger BioPharmaceuticals announced that LOWR HDV-4 phase 2 study dosing is complete, according to a press release.

“We are very pleased to conduct our first study with lonafarnib combined with ritonavir in HDV-infected patients,” Heiner Wedemeyer, MD, research group leader in the department of gastroenterology, hepatology and endocrinology at Hannover Medical School in 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 enabled us to investigate lonafarnib in combination with ritonavir in HDV-infected patients with dose escalation or titration at pre-specified times.”

The researchers are conducting the phase 2 LOWR HDV-4 study at Hannover Medical School. LOWR-HDV-4 is a 15-patient 24-week open-label study evaluating the efficacy and tolerability of lonafarnib (Sarasar, Eiger BioPharmaceuticals) and ritonavir administered twice per day in patients with hepatitis D. Lonafarnib is an orally active inhibitor of farnesyl transferase — an enzyme involved in protein modification through prenylation — which is used by hepatitis D to complete a key step in its life cycle in liver host cells.

The FDA has already granted orphan drug and fast track designation to the drug. The European Medicines Agency has also granted orphan drug designation.

“Hepatitis D causes the most aggressive form of human viral hepatitis, with fast progression to cirrhosis and other life-threatening complications, and there is no approved treatment,” Eduardo Martins, MD, PhD, senior vice president of liver and infectious diseases drug development at Eiger BioPharmaceuticals, said in the release. “As part of the phase 2 LOWR HDV program, including LOWR HDV-2, 3 and 4 studies, the LOWR HDV-4 study was designed to help elucidate the antiviral potential of lonafarnib in combination with ritonavir with dose escalation. We look forward to analysis and presentation of results in conjunction with the entire LOWR HDV program.” – by Will Offit

Disclosure: Wedemeyer is an employee of Hannover Medical School and Martins is an employee of Eiger.