Eiger BioPharmaceuticals said that it has dosed the first patients in a phase 2 trial of its hepatitis delta virus drug candidate peginterferon lambda (Lambda) in outpatients at the Stanford University School of Medicine having mild COVID-19.
The California-based biopharma company said that nearly 120 patients will be randomly grouped in a 1:1 ratio to receive a single subcutaneous dose of Lambda or normal saline placebo in the mid-stage trial. Eiger BioPharmaceuticals aims to assess the efficacy of Lambda in bringing down the duration of viral shedding of SARS-CoV-2 virus and in reducing the duration of symptoms and hospitalization in patients having mild COVID-19.
Patients taking part in the COVID-19 trial will be followed for 28 days.
The Stanford trial is co-led by Upinder Singh, Professor of Medicine and Infectious Diseases and Geographic Medicine and Microbiology and Immunology and Prasanna Jagannathan, Assistant Professor of Medicine and Infectious Diseases.
According to Eiger BioPharmaceuticals, Lambda interferon plays an important role in the targeted innate immune response against viral pathogens that cause infection in the respiratory tract. After infecting the airway epithelial cells, type III IFNs such as lambda interferon are produced first and act as the first line of defense to restrict virus spread at the epithelial barrier without triggering inflammation.
The phase 2 trial will probe the hypothesis that Lambda could be most effective in patients who have confirmed infection with mild symptoms with a goal to cut down both the duration and severity of COVID-19.
Colin Hislop – Senior Vice President of Clinical and Development Operations at Eiger BioPharmaceuticals said: “SARS-CoV-2 induces very weak expression of interferons in infected cells.
“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 among the six international, investigator-sponsored studies that are assessing Lambda in COVID-19. Other sites include Soroka University (Israel), Mount Sinai Hospital (New York), Johns Hopkins University (Baltimore), Massachusetts General Hospital (Boston), and University of Toronto (Toronto).
Eiger BioPharmaceuticals has been engaged in protocol development, regulatory interactions, and is taking care of Lambda clinical drug supply. Put together, up to 400 patients are likely to be enrolled and dosed across global sites to evaluate the ability of Lambda in reducing the replication of COVID-19 and in limiting transmission of the virus.