Eiger BioPharmaceuticals Announces First Patients Dosed with Peginterferon Lambda in Phase 3 TOGETHER Study of Newly Diagnosed COVID-19 Outpatients
07/06/2021 - 08:00 AM
PALO ALTO, Calif. , July 6, 2021 /PRNewswire/ -- Eiger BioPharmaceuticals, Inc. (Nasdaq:EIGR), a commercial-stage biopharmaceutical company focused on the development and commercialization of targeted therapies for serious rare and ultra-rare diseases, today announced that the first patients were dosed with Peginterferon Lambda (Lambda) in the Phase 3 TOGETHER platform study in outpatients with COVID-19. Lambda is administered as a convenient, one-time, subcutaneous dose.
TOGETHER is a multi-center, investigator-sponsored, randomized, placebo-controlled Phase 3 study evaluating multiple therapeutics in newly diagnosed, outpatients with COVID-19. The primary endpoint is a clinical outcome comparing emergency room visits and/or hospitalization in each active arm versus placebo. Each arm targets enrollment of up to 800 patients at high risk for developing complications from progression of COVID-19, with planned interim analyses for futility.
"Effective treatments are desperately needed for newly diagnosed COVID-19 outpatients that can be quickly and easily administered upon diagnosis, outside the hospital," said David Cory , President and CEO of Eiger. "Lambda stimulates immune responses that are critical for the development of host protection during viral infections and may be ideal for addressing variants of SARS-CoV-2, which remain an ongoing concern with approved monoclonal antibodies and vaccines. We are excited to include Lambda in the TOGETHER study and look forward to reporting results in the future."
For more information about the TOGETHER platform study, please visit www.togethertrial.com .
About Peginterferon Lambda (Lambda) Lambda is a well-characterized, first-in-class, type III, well-tolerated 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 which are more ubiquitously distributed throughout the body. Lambda receptors are largely restricted to cells and tissues of epithelial origin, including respiratory epithelial cells, lending itself to less off target effects.
Interferon lambda is critical for maintaining a balanced antiviral response in the respiratory tract. They are induced at lower viral burden to limit the initial infection, before type I IFNs, 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 without development of cytokine storms.
Eiger is developing Lambda 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.
About Eiger Eiger is a commercial-stage biopharmaceutical company focused on the development and commercialization of targeted therapies for serious rare and ultra-rare diseases.
Eiger's lead clinical programs are focused on the development of foundational therapies for Hepatitis Delta Virus (HDV) infection, the most serious form of viral hepatitis, with two complementary HDV treatments. Lonafarnib is a first-in-class, oral prenylation inhibitor in a global Phase 3 trial. Peginterferon lambda is a first-in-class, type III, well-tolerated 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 approved product. A Marketing Authorization Application (MAA) is under review by the European Medicines Agency (EMA).
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. Words such as "will," "may," "continue," "plan," "expect," "could," "potential" and similar expressions are intended to identify forward-looking statements. These statements include those regarding the potential of Lambda to be an effective therapy for newly diagnosed outpatients with COVID-19; the timing and results of the TOGETHER platform study; and the potential for success of any of our product candidates. These forward-looking statements are subject to risks and uncertainties, including, without limitation, risks and uncertainties associated with the costly and time-consuming pharmaceutical product development process and the uncertainty of clinical success, including risks related to failure or delays in successfully initiating, enrolling or completing clinical studies, including the TOGETHER platform study; the risks that results obtained in clinical trials to date may not be inductive of results obtained in ongoing or future trials; the time-consuming and uncertain regulatory approval process; the sufficiency of Eiger's cash resources; and other risks and uncertainties described in the "Risk Factors" sections in the Quarterly Report on Form 10-Q for the quarter ended March 31, 2021 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.
Charles Butler cbutler@eigerbio.com
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SOURCE Eiger BioPharmaceuticals, Inc.
