Eiger Announces HDV Phase 2 Program Oral Presentation and Investigator / Key Opinion Leader Reception for Planned HDV Phase 3 D-LIVR Study at Global Hepatitis Summit 2018™
Events at Global Hepatitis Summit 2018™ listed below:
- Yurdaydin, C. et al; "A Phase 2 Dose-Optimization Study of Lonafarnib with Ritonavir for the Treatment of Chronic Delta Hepatitis — Analysis from the LOWR HDV-2 Study Using the Robogene® Real-Time qPCR HDV RNA Assay"; Session 5, Clinical Science: HDV Pathogenesis and Treatment, Abstract #O-010, Oral Presentation,
June 15 ,12:00 pm –12:15 pm EDT . - Phase 3 D-LIVR Study Investigator / Key Opinion Leader Reception — Update on study design, program strategy and plans;
June 15 ,5:00 pm –9:00 pm EDT (Invitation Only)
About Lonafarnib
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. Our lead program in Hepatitis Delta Virus (HDV) infection, is advancing lonafarnib into Phase 3 with the D-LIVR Study, a single, pivotal trial planned to initiate by the end of 2018.
Lonafarnib has been granted Orphan Drug Designation by the
Eiger is also developing lonafarnib for the treatment of Hutchinson-Gilford Progeria Syndrome (HGPS) and plans to seek
Lonafarnib is not approved for any indication and is licensed from
About Phase 3 D-LIVR Study
D-LIVR (Delta Liver Improvement and Virologic Response in HDV) is expected to be an international, multi-center, Phase 3 study of approximately 300 patients to evaluate an all-oral arm of lonafarnib (LNF) + ritonavir (RTV) and a combination arm of LNF + RTV + pegylated interferon-alfa (PEG IFN-α), with each arm to be compared to a placebo arm (background HBV nucleos(t)ide only), in HDV-infected patients. A PEG IFN-α alone arm will be dosed to demonstrate contribution of effect only. The LNF containing arms will not be required to demonstrate superiority over PEG IFN-α alone. The company is currently defining primary and secondary endpoints with the FDA. D-LIVR is planned to initiate by end of the year.
About Hepatitis Delta Virus (HDV)
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
About Eiger
Eiger is a late stage biopharmaceutical company focused on the development and commercialization of targeted therapies for rare diseases. We innovate by developing well-characterized drugs in newly identified or novel targets in rare diseases. Our mission is to systematically reduce the time and cost of the drug development process to more rapidly deliver important medicines to patients. Our lead program in Hepatitis Delta Virus (HDV) infection is advancing into Phase 3 with a single, pivotal trial (D-LIVR Study) planned to initiate by the end of 2018. For additional information about Eiger and its clinical programs, please visit www.eigerbio.com.
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