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."
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.
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.
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