Eiger BioPharmaceuticals has said that its investigational agent, Peginterferon Lambda, will be added to the Phase III TOGETHER platform study of Covid-19 outpatients in Brazil.
A type III interferon (IFN), Lambda induces immune responses required for developing host protection during viral infections. Eiger licensed the therapeutic from Bristol-Myers Squibb.
Eiger noted that the IFN lambda administration has demonstrated the ability to suppress replication of virus while preventing the development of cytokine storm.
The ongoing, multi-centre, investigator-sponsored, randomised, placebo-controlled TOGETHER study is assessing various therapeutics in newly diagnosed Covid-19 patients who are not hospitalised.
With the latest development, the trial will have an investigational arm of patients receiving a single dose of Lambda subcutaneously.
Each trial arm plans to enrol up to 800 Covid-19 patients at high risk of developing complications from disease progression. Interim analyses for futility will be carried out in all arms.
At present, the study is enrolling subjects at 11 sites in Brazil, with plans to expand to a site in Toronto, Canada.
Clinical outcome comparing emergency room visits and/or hospitalisation in each active arm against placebo will form the primary endpoint of the trial.
Eiger BioPharmaceuticals president and CEO David Cory said: “Resistance due to variants or new strains of SARS-CoV-2 is an ongoing concern with approved monoclonal antibodies and vaccines.
“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.
“Based upon the convenience of administration and a mechanism that is agnostic to arising variants, we believe Lambda may be ideally suited to treat newly diagnosed Covid-19 outpatients.”
Eiger is currently developing Lambda as a monotherapy, as well as in combination with lonafarnib plus ritonavir for treating hepatitis delta virus infection.
So far, more than 3,000 participants in 23 clinical trials of hepatitis B (HBV), hepatitis C (HCV), hepatitis D (HDV), and Covid-19 have received Lambda.