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Dosing complete in Eiger BioPharmaceuticals’ LOWR HDV-3 study
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Eiger BioPharmaceuticals Inc. has announced the completion of dosing in its phase 2 LOWR HDV-3 study.
A double blind, randomized, placebo-controlled study, LOnafarnib With Ritonavir in Hepatitis Delta Virus -3 aims to evaluate the tolerability and efficacy of lonafarnib (Sarasar, Eiger Biopharmaceuticals) plus ritonavir. In the study, performed at the NIH Clinical Center in Bethesda, Maryland, researchers placed 21 patients with chronic hepatitis delta into six treatment groups. They then assigned patients one of three doses – 50 mg, 75 mg or 100 mg – of lonafarnib once daily, combined with ritonavir 100 mg once daily for 12 or 24 weeks.
“LOWR HDV-3 is designed to help elucidate the antiviral potential of once daily dosing of lonafarnib in combination with ritonavir in a longer duration study, and we eagerly await results,” Eduardo Martins, MD, DPhil, senior vice president of Liver and Infectious Diseases Drug Development at Eiger BioPharmaceuticals, said in a press release.
Lonafarnib is a late-stage, orally active farnesyl transferase inhibitor licensed from Merck Sharp & Dohme Corp. Though it is not approved for any indication, it has received Orphan Drug Designation by the FDA and European Medicines Agency, as well as Fast Track Designation by the FDA.