Eiger BioPharmaceuticals Announces Interim Analysis and Continuation of Dosing of Peginterferon Lambda in Phase 3 TOGETHER Study of Newly Diagnosed COVID-19 Outpatients
PALO ALTO, Calif.,
TOGETHER is a multi-center, investigator-sponsored, randomized, placebo-controlled adaptive platform Phase 3 study evaluating therapeutics in newly diagnosed, high-risk, non-hospitalized patients with COVID-19. The primary endpoint is a clinical outcome comparing emergency setting visits and/or hospitalization in each active arm versus placebo. The DSMB provides independent oversight for the trial and has previously discontinued five other therapeutics due to observed futility. The Peginterferon Lambda arm targets enrollment of up to 800 patients at high risk for developing complications from progression of COVID-19. The TOGETHER platform study is currently recruiting at twelve sites in Brazil.
"We are pleased that the DSMB has recommended to continue enrolling the Peginterferon Lambda arm in the TOGETHER study," said Edward Mills, PhD, Principal Investigator, Professor of Health Research Methods, Evidence, and Impact at McMaster University, Vancouver,
"Resistance due to variants or new strains of SARS-CoV-2 is an ongoing concern with approved treatments as well as vaccines," said
For more information about the TOGETHER platform study, please click here.
About Peginterferon Lambda
Peginterferon 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. Peginterferon 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.
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
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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 "will," "may," "continue," "plan," "expect," "could," "potential" 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, the potential of Lambda to be an effective therapy for newly diagnosed outpatients with COVID-19; 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
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