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™
Published: Jun 04, 2018
PALO ALTO, Calif., June 4, 2018 /PRNewswire/ -- Eiger BioPharmaceuticals, Inc (Nasdaq: EIGR), focused on the development and commercialization of targeted therapies for rare diseases, announced today that an oral presentation from the Phase 2 LOWR HDV (LOnafarnib With Ritonavir in Hepatitis Delta Virus) Program as well as an update on the Phase 3 D-LIVR study will be presented at Global Hepatitis Summit 2018™ in Toronto, Canada, June 14-17, 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)
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 U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA), and Fast Track Designation by U.S. FDA for HDV.
Eiger is also developing lonafarnib for the treatment of Hutchinson-Gilford Progeria Syndrome (HGPS) and plans to seek FDA guidance regarding next steps.
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).
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 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.
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.
Note Regarding Forward-Looking Statements
This press release contains "forward-looking" statements that involve substantial risks and uncertainties. All statements other than statements of historical facts, including statements regarding our future financial condition, timing for and outcomes of clinical results, business strategy and plans and objectives for future operations, are forward looking statements. These forward-looking statements include terminology such as "believe," "will," "may," "estimate," "continue," "anticipate," "contemplate," "intend," "target," "project," "should," "plan," "expect," "predict," "could," "potentially" or the negative of these terms. Forward looking statements are our current statements regarding our intentions, beliefs, projections, outlook, analyses or current expectations concerning, among other things, our ongoing and planned clinical development, including whether Eiger would be permitted to file an NDA based on PRF data and the timing and outcome of any FDA meeting with respect to lonafarnib and Progeria, the D-LIVR study will be supported by the FDA as a single, pivotal study to support registration; the timing of and our ability to initiate or enroll clinical trials, including whether our D-LIVR study can be advanced by the end of this year; our ability to make timely regulatory filings and obtain and maintain regulatory approvals for lonafarnib as a single agent or in combination, ubenimex, PEG IFN lambda, exendin 9-39 and our other product candidates; our intellectual property position; and the potential safety, efficacy, reimbursement, convenience clinical and pharmaco-economic benefits of our product candidates as well as the commercial opportunities, including potential market sizes and segments; our ability to finance the continued advancement of our development pipeline products, including our results of operations, cash available, financial condition, liquidity, prospects, growth and strategies; and the potential for success of any of our product candidates.
Various important factors could cause actual results or events to differ materially from the forward-looking statements that Eiger makes, including the risks described in the "Risk Factors" sections in the Quarterly Report on Form 10-Q for the quarter ended March 31, 2018 and Eiger's periodic reports filed with the SEC. Eiger does not assume any obligation to update any forward-looking statements, except as required by law.
SOURCE Eiger BioPharmaceuticals, Inc.
Investors: Ingrid Choong, PhD
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