Eiger BioPharmaceuticals, Inc. announced additional positive lonafarnib (LNF) data from the LOWR HDV (LOnafarnib With Ritonavir in Hepatitis Delta Virus) Program presented at The International Liver Congress 2018, in Paris, France. A subanalysis of the LOWR-2 study reveals high response rates to LNF all-oral therapy in patients with low baseline viral loads = 4 logs. After 24 weeks of treatment, all-oral lonafarnib-based regimens (LNF 50 mg BID + Ritonavir, or RTV) suppressed HDV-RNA below the limit of quantitation (BLQ) in 100% of patients with low baseline viral loads = 4 logs. In addition, HDV-infected patients with high baseline viral loads > 4 logs responded well to combination therapy of LNF + RTV + PEG IFN-a-2a, where 50% were BLQ and 88% achieved = 2 log decline at Week 24. LOWR HDV – 2 was a dose-finding study to identify combination regimens of lonafarnib and ritonavir ± PEG IFN a, with efficacy and tolerability for longer term dosing to enable HDV RNA clearance. In this open-label study, 58 HDV-infected patients were enrolled to date into 10 groups of different doses of lonafarnib in combination with ritonavir ± PEG IFN a for dosing durations of 12 to 48 weeks. Lonafarnib doses range from 25 mg BID to 100 mg BID. LOWR HDV – 2 was conducted at Ankara University in Ankara, Turkey, and this study has completed. Lonafarnib is a well-characterized, late-stage, orally active inhibitor of farnesyl transferase, an enzyme involved in modification of proteins through a process called prenylation. HDV uses this host cell process inside liver cells to complete a key step in its life cycle. Lonafarnib inhibits the prenylation step of HDV replication inside liver cells and blocks the virus life cycle at the stage of assembly. Lonafarnib has been dosed in over 120 HDV-infected patients across international academic centers and has completed Phase 2 development for HDV. The company's lead program in Hepatitis Delta Virus (HDV) infection, is moving into Phase 3 with a single, pivotal trial planned to initiate by the end of the year. Lonafarnib has been granted Orphan Drug Designation by the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA), and Fast Track Designation by U.S. FDA. Lonafarnib is not approved for any indication, and is licensed from Merck Sharp & Dohme Corp. (known as MSD outside of the United States and Canada). Hepatitis Delta is caused by infection with HDV and is considered to be one of the most severe forms of viral hepatitis in humans. Hepatitis delta occurs only as a co-infection in individuals harboring Hepatitis B Virus (HBV). Hepatitis delta leads to more severe liver disease than HBV alone and is associated with accelerated liver fibrosis, liver cancer, and liver failure. Hepatitis delta is a disease with a significant impact on global health, which may affect up to approximately 15-20 million people worldwide. The prevalence of HDV varies among different parts of the world. Globally, HDV infection is reported to be present in approximately 4.3% to 5.7% of chronic Hepatitis B carriers. The prevalence of HDV in patients infected with chronic HBV is even higher in certain regions, including certain parts of Mongolia, China, Russia, Central Asia, Pakistan, Turkey, Africa, Middle East and South America, with an HDV prevalence as high as 60% being reported in HBV-infected patients in Mongolia and Pakistan.