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LONDON, UK / ACCESSWIRE / March 23, 2018 / Active-Investors.com has just released a free research report on Eiger BioPharma, Inc. (NASDAQ: EIGR) ("Eiger"). If you want access to this report all you need to do is sign up now by clicking the following link www.active-investors.com/registration-sg/?symbol=EIGR as the Company's latest news hit the wire. On March 21, 2018, the Company announced that the US Food and Drug Administration (FDA) has permitted that a single, registration trial evaluating lonafarnib in Hepatitis Delta Virus (HDV) can support a New Drug Application (NDA) filing. The positive guidance followed the discussion on the Hepatitis Delta Virus registration program in February 2018. Register today and get access to over 1,000 Free Research Reports by joining our site below:
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Active-Investors.com is focused on giving you timely information and the inside line on companies that matter to you. This morning, Eiger BioPharma most recent news is on our radar and our team decided to put out a fantastic report on the company that is now available for free below:
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D-LIVR Will Evaluate an All-Oral Arm of Lonafarnib + Ritonavir
D-LIVR (Delta Liver Improvement and Virologic Response in HDV) will be an international, multi-center, Phase-3 study of 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, in HDV-infected patients. A PEG IFN-α alone arm will be dosed to demonstratecontribution of effect only. The LNF containing arms will not be required to demonstrate superiority over PEG IFN-α alone. Eiger is currently defining primary and secondary endpoints with the FDA.
Eiger Also Plans to Launch Phase-2 Study of Lambda in Combination with LNF and RTV
The discussion also supported the development of pegylated interferon lambda (Lambda) in HDV infection. Eiger also plans a Phase-2 study of Lambda in combination with LNF and RTV. LIFT (Lambda InterFeron combo-Therapy) is an open-label, Phase-2 study evaluating Lambda + LNF + RTV in approximately 26 HDV-infected patients. Patients will be dosed for 24 weeks and will undergo follow up for 24 weeks. Primary endpoint will decline in HDV RNA at end of treatment. Patient enrollment in LIFT is planned for Q2 2018.
Eiger Will Share Additional Information on the Planned Registration Program in Q2 2018
David Cory, President and Chief Executive Officer of Eiger, stated that the Company looks forward to advancing a single pivotal trial in HDV using a lonafarnib-based regimen. Eiger is executing on its goal to develop the first approved therapy for HDV patients, with opportunities for label expansion and increased therapeutic options in the future.
David added that the Company expects to share additional information on the planned registration program in Q2 2018.
Eiger Reported Positive Phase-2 Interim Data with Lambda in HDV Infection
In October 2017, the Company presented positive interim 24-week data with pegylated interferon lambda (Lambda) in the Phase-2 LIMT HDV (Lambda Interferon MonoTherapy in HDV) Study at the American Association for the Study of Liver Diseases (AASLD) meeting in Washington DC. LIMT HDV, a 1:1 randomized, open-label study of Lambda 120 or 180 microgram subcutaneous injections administered weekly for 48 weeks in chronic HDV, enrolled 33 patients. At the time of this analysis, Lambda interferon demonstrated similar efficacy as previously seen with Alfa interferon in the treatment of HDV infection and importantly, was better tolerated.
About Lonafarnib and Pegylated Interferon Lambda
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 cellular process inside liver cells to complete a key step in its life cycle. Lonafarnib inhibits the prenylation step of HDV replication and blocks the ability of the virus to multiply. Lonafarnib is licensed from Merck Sharp & Dohme Corp. Lonafarnib has been granted Orphan Drug Designation by the FDA and European Medicines Agency (EMA).
Lambda is a well-characterized, late-stage, first in class, type-III interferon (IFN) that stimulates immune responses that are critical for the development of host protection during viral infections. Lambda targets type III IFN receptors. Eiger licensed worldwide rights to Lambda from Bristol-Myers Squibb in April 2016. Eiger has received Orphan Designation and Fast Track Designation for Lambda in HDV.
About Hepatitis Delta Virus
Hepatitis D virus (HDV) is a ribonucleic acid (RNA) virus that requires hepatitis B virus (HBV) for its replication. HDV infection occurs only simultaneously or as super-infection with HBV. The virus is transmitted through contact with the blood or other body fluids of an infected person. Vertical transmission from mother to child is rare. Hepatitis Delta leads to more severe liver disease than HBV alone and is associated with accelerated liver fibrosis, liver cancer, and liver failure.
About Eiger BioPharmaceuticals, Inc.
Founded in 2008 and is headquartered in Palo Alto, California, Eiger BioPharma is a clinical stage biopharmaceutical company focused on the discovery and development of new antiviral agents against novel targets in the treatment of hepatitis.
Stock Performance Snapshot
March 22, 2018 - At Thursday's closing bell, Eiger BioPharma's stock advanced 5.26%, ending the trading session at $10.00.
Volume traded for the day: 173.38 thousand shares, which was above the 3-month average volume of 155.57 thousand shares.
Stock performance in the last month – up 14.94%
After yesterday's close, Eiger BioPharma's market cap was at $108.00 million.
The stock is part of the Healthcare sector, categorized under the Biotechnology industry.
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