Eiger BioPharmaceuticals Announces Second Positive Interim Analysis and Continuation of Dosing of Peginterferon Lambda in Phase 3 TOGETHER Study of Newly Diagnosed COVID-19 Patients
PALO ALTO, Calif.,
"We are pleased that the DSMB has now completed a second interim futility analysis on a larger sample of Peginterferon Lambda treated patients and recommended to continue enrollment," said Edward Mills, PhD, Principal Investigator, Professor of Health Research Methods, Evidence, and Impact at McMaster University Hamilton,
"Peginterferon Lambda stimulates immune responses critical to innate defenses with a mechanism of action agnostic to variants of SARS-CoV-2 and resistance concerns with other treatments," said David Cory, President and Chief Executive Officer at Eiger. "A single subcutaneous injection of Peginterferon Lambda administered to newly diagnosed COVID-19 patients may reduce complications and prevent hospitalizations, with or without other treatments. We look forward to reporting results of the TOGETHER study."
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. Peginterferon Lambda is currently the only therapeutic being investigated in TOGETHER. The primary endpoint compares number of emergency setting visits, hospitalizations, and/or deaths in treated patients versus placebo through Day 28. The DSMB provides independent oversight for the trial and has previously discontinued five other therapeutics due to observed futility. TOGETHER is expected to enroll as many as 1,600 patients (1:1 Peginterferon Lambda vs placebo) at high risk for developing complications from progression of COVID-19. TOGETHER is currently recruiting at twelve sites in Brazil.
For more information about TOGETHER, 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. Administration of IFN lambda has been shown to suppress viral replication while stopping 'cytokine storm' from developing.
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 within the meaning of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. 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. Forward-looking statements are our current statements regarding our intentions, beliefs, projections, outlook, analyses or current expectations concerning, among other things, our anticipated significant milestones in 2021 and 2022; the timing of our ongoing and planned clinical development; the sufficiency of our cash, cash equivalents and investments to fund our operations; and the potential of Lambda to be an effective therapy for newly diagnosed outpatients with COVID-19. Various important factors could cause actual results or events to differ materially from the forward-looking statements that
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