PALO ALTO, Calif., Feb. 8, 2021 /PRNewswire/ -- Eiger BioPharmaceuticals, Inc (Nasdaq:EIGR), a commercial-stage biopharmaceutical company focused on the development and commercialization of foundational therapies for Hepatitis Delta Virus (HDV) infection, today announced that final results from the Phase 2 ILIAD (Interferon Lambda for Immediate Antiviral Therapy at Diagnosis in COVID-19) study published in Lancet Respiratory Medicine.
ILIAD, an investigator sponsored randomized trial of Peginterferon Lambda (Lambda) in outpatients with mild to moderate COVID-19 conducted at Toronto General Hospital, University Health Network in Toronto, Canada, demonstrated a single dose of Lambda accelerated clearance of SARS-CoV2 in newly diagnosed, non-hospitalized patients. Rapid clearance of SARS-CoV2 has potential to improve clinical outcomes and curb community spread, particularly in those with high viral levels, as those cases are associated with more severe disease and a higher risk of transmission to others. This may have important additional public health impact. Among the 60 patients followed in the study, five required emergency room visits due to deteriorating respiratory symptoms (four in the placebo group, one in the Lambda group). Lambda was well-tolerated with few adverse events, which included minimal elevations of transaminases which self-resolved.
Eiger previously reported topline data from this study on October 15, 2020.
"Lambda has large therapeutic potential, especially at this moment as we see aggressive variants of the virus spreading around the globe which are less sensitive to both vaccines and treatment with antibodies," said Jordan Feld, MD, MPH, Associate Professor of Medicine at University of Toronto and Senior Scientist at Toronto Centre for Liver Disease and Toronto General Hospital Research Institute. "Resistance due to variants or new strains of the virus could be an issue with some therapies, but this may not be a concern with Lambda due to its mechanism by activation of multiple virus-killing pathways."
Eiger is finalizing FDA regulatory guidance on a potential Phase 2/3, registration-enabling study of Lambda in COVID-19, including study size and endpoints, which will determine next steps to advance Lambda in COVID-19.
About Peginterferon Lambda (Lambda)
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 which are distinct from the type I IFN receptors targeted by IFN alfa. Binding leads to activation of JAK-STAT signaling pathway and upregulation of numerous IFN-stimulated genes (ISGs). IFN lambda receptors are largely restricted to cells and tissues of epithelial origin, including respiratory epithelial cells.
IFN lambdas are critical for maintaining a balanced antiviral response in the respiratory tract. They are induced at lower viral burden before type I IFNs to limit the initial infection by inducing viral resistance to cells and helping them deal with the virus load. IFN lambda lacks the strong pro-inflammatory effects of type I IFNs and are tissue-protective and anti-inflammatory. Administration of IFN lambda has been shown to suppress viral replication while stopping the 'cytokine storm' from developing.
Eiger is developing Lambda as a monotherapy and in combination with lonafarnib boosted with ritonavir for the treatment of hepatitis delta virus (HDV) infection. Lambda has been administered to over 3,000 subjects in 23 clinical trials of HBV, HCV, HDV and COVID-19. Lambda is an investigational agent and not yet approved for any indication. Eiger has received Orphan Designation by the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA), and Fast Track and Breakthrough Therapy Designation by FDA for Lambda in HDV.
Eiger licensed worldwide rights to Lambda from Bristol-Myers Squibb.
Eiger is a commercial-stage biopharmaceutical company focused on the development and commercialization of foundational therapies for 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.
Zokinvy for the treatment of Hutchinson-Gilford Progeria Syndrome (HGPS or Progeria) and processing-deficient Progeroid Laminopathies is the Company's first FDA approval. A Marketing Authorization Application (MAA) is under review by the European Medicines Agency (EMA). Outside the U.S., Eiger's established global Managed Access Program, expected to span greater than 40 countries, ensures all children and young adults with Progeria and Progeroid Laminopathies have access to treatment.
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 2021, the timing of our ongoing and planned clinical development, including our ability to support the launch of a new product and ship to specialty pharmacies; the sufficiency of our cash, cash equivalents and investments to fund our operations through at least Q4 2023; the expected closing of the sale of our PRV; our development programs for Zokinvy generally; and the potential approval of Zokinvy in jurisdictions outside of the U.S., including the EU; the risks related to the commercialization of Zokinvy, our ability to manufacture sufficient quantities of Zokinvy, and the commercial launch of Zokinvy in the U.S., the market potential for Zokinvy as a treatment for Progeria and processing-deficient Progeroid Laminopathies; our progression and enrollment of our Phase 3 D-LIVR study in HDV; our ability to maintain supply of our commercial and clinical trial materials; 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 September 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.
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