PALO ALTO, Calif., Nov. 2, 2020 /PRNewswire/ -- Eiger BioPharmaceuticals, Inc. (Nasdaq:EIGR), focused on the development and commercialization of targeted, first-in-class therapies for serious rare and ultra-rare diseases, today announced that data from its Hepatitis Delta Virus (HDV) programs are featured in three abstracts accepted for presentation during The Liver Meeting Digital Experience™ (TLMdX). This annual meeting of the American Association for the Study of Liver Diseases (AASLD) will be hosted virtually November 13-16, 2020.
Late-Breaking Oral Presentation L08: A Phase 2 Study of Peginterferon Lambda, Lonafarnib, and Ritonavir for 24 Weeks: End-Of-Study Results from the LIFT HDV Study. Presented by Christopher Koh, MD, MHSc FAASLD, Liver Disease Branch, National Institute of Diabetes Digestive and Kidney Diseases, National Institutes of Health.
Late BreakingPosterLP24: Noninvasive Tests for Detection of Biopsy-Proven Cirrhosis in Chronic Hepatitis D Infected Patients Are Suboptimal. Presented by Ohad Etzion, MD, Faculty of Health Sciences, Ben-Gurion University of the Negev; Director, Department of Gastroenterology and Liver Diseases, Soroka University Medical Center.
Poster1027:Regression of Liver Fibrosis Following 48 Weeks of Therapy With Peginterferon Lambda in Patients with Chronic Hepatitis Delta Virus (HDV) Infection. Presented by David Yardeni, MD, Gastroenterology and Liver Diseases, Soroka University Medical Center; Faculty of Health Sciences, Ben-Gurion University of the Negev.
About Peginterferon Lambda (Lambda) Lambda is a well-characterized, 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 which are distinct from the type I IFN receptors targeted by IFN alfa. Lambda type III receptors are highly expressed on hepatocytes with limited expression on hematopoietic and central nervous system cells, which may reduce off-target effects and improve tolerability of Lambda.
Lambda is Phase 3 ready in development as a treatment for HDV. Eiger has received Orphan Designation by the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA), and Fast Track and Breakthrough Designation by FDA for Lambda in HDV. Lambda is not yet approved for any indication. Eiger licensed worldwide rights to Lambda from Bristol-Myers Squibb.
About Lonafarnib Lonafarnib is a well-characterized, late-stage, oral inhibitor of farnesyl transferase, an enzyme involved in modification of proteins through a process called prenylation, a vital process in the life cycle of HDV. Blocking prenylation of the large delta hepatitis antigen (LDHAg) reduces HDV replication.
Lonafarnib has been dosed in over 150 HDV-infected patients across international academic centers and is in Phase 3 global, pivotal trial (D-LIVR Study). Lonafarnib has been granted Orphan Drug designation by the U.S. FDA and European Medicines Agency (EMA), Fast Track and Breakthrough designation by U.S. FDA and PRIME designation by the EMA. Lonafarnib is not approved for any indication. Eiger licensed worldwide rights to Lonafarnib from Merck Sharp & Dohme Corp. (known as MSD outside of the United States and Canada).
About Eiger Eiger is a late-stage biopharmaceutical company focused on the development and commercialization of first-in-class, well-characterized drugs for serious rare and ultra-rare diseases for patients with high unmet medical needs.
Eiger's lead clinical programs target Hepatitis Delta Virus (HDV) infection, the most serious form of human viral hepatitis. Eiger is developing two complementary treatments for HDV. Lonafarnib is a first-in-class, oral prenylation inhibitor in a global Phase 3 trial. Peginterferon lambda is a first-in-class, well-tolerated type III interferon entering Phase 3.
Eiger has filed an NDA and MAA for lonafarnib for the treatment of Hutchinson-Gilford Progeria Syndrome (HGPS or Progeria) and Progeroid Laminopathies. FDA PDUFA date is November 20, 2020.
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 anticipating significant milestones in 2020 and 2021, the timing of our ongoing and planned clinical development, including the potential for approval of our lonafarnib product candidate in the U.S. and EU for Progeria and Progeroid Laminopathies; our progression and enrollment of our Phase 3 D-LIVR study in HDV; our ability to maintain supply of our clinical trial materials; our announcement of data from the trial of Lambda and lonafarnib boosted with ritonavir for HDV (LIFT); our plans to advance Lambda in HDV in the U.S. and EU; our ability to transition into a commercial stage biopharmaceutical company; our ability to finance the continued advancement of our development pipeline products; and the potential for success of any of our product candidates. These statements concern product candidates that have not yet been approved for marketing by the U.S. Food and Drug Administration (FDA). No representation is made as to their safety or effectiveness for the purposes for which they are being investigated.
Various important factors could cause actual results or events to differ materially from the forward-looking statements that Eiger makes, including additional applicable risks and uncertainties described in the "Risk Factors" sections in the Quarterly Report on Form 10-Q for the quarter ended June 30, 2020 and Eiger's subsequent filings with the SEC. The forward-looking statements contained in this press release are based on information currently available to Eiger and speak only as of the date on which they are made. Eiger does not undertake and specifically disclaims any obligation to update any forward-looking statements, whether as a result of any new information, future events, changed circumstances or otherwise.