Eiger BioPharmaceuticals, Inc (Nasdaq:EIGR),
focused on the development and commercialization of targeted therapies
for serious rare and ultra-rare diseases, today announced that the first
patients have been dosed in a Phase 2 study of peginterferon lambda
(Lambda) in outpatients with mild COVID-19 at the Stanford University School of Medicine.
Approximately 120 patients will be randomized 1:1 to a single
subcutaneous dose of Lambda or normal saline placebo to evaluate the
efficacy of Lambda in reducing the duration of viral shedding of
SARS-CoV-2 virus and in reducing duration of symptoms and
hospitalization in patients with mild COVID-19. Patients will be
followed for 28 days.
The Stanford study is co-led by Upinder Singh, MD, Professor of Medicine and Infectious Diseases and Geographic Medicine and Microbiology and Immunology and Prasanna Jagannathan, MD, Assistant Professor of Medicine and Infectious Diseases.
Lambda interferon plays a key role in the targeted innate immune
response against viral pathogens that infect the respiratory tract. Upon
infection of airway epithelial cells, type III IFNs, like lambda
interferon, are produced first and act as the initial line of defense to
limit virus spread at the epithelial barrier without triggering
inflammation. The study will investigate the hypothesis that Lambda may
be most effective in patients who have confirmed infection with mild
symptoms in order to reduce duration and severity of COVID-19.
“SARS-CoV-2 induces very weak expression of interferons in infected cells,” said Colin Hislop,
MD, Senior Vice President of Clinical and Development Operations.
“Absence of interferon production likely hampers the early innate immune
response to SARS-CoV-2 infection and suggests stimulation of antiviral
immunity with exogenous lambda interferon might be successful for
treating SARS-CoV-2 infection.”
The Stanford study is one of six
international, investigator sponsored studies evaluating Lambda in
COVID-19. Other sites include Soroka University (Israel), Mount Sinai Hospital (New York), Massachusetts General Hospital (Boston), Johns Hopkins University (Baltimore), and University of Toronto (Toronto). Eiger
has been involved in protocol development, regulatory interactions and
is providing Lambda clinical drug supply. Collectively, up to 400
patients are expected be enrolled and dosed across international
sites. These studies will assess Lambda’s ability to reduce COVID-19
replication and limit virus transmission.
https://www.biospace.com/article/releases/eiger-biopharmaceuticals-announces-first-covid-19-patients-dosed-with-peginterferon-lambda/
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