Eiger BioPharmaceuticals has dosed the first subjects in the Phase III TOGETHER platform trial of its investigational agent, Peginterferon Lambda, for Covid-19 in outpatient settings.
Licenced from Bristol-Myers Squibb, Lambda is administered as a single subcutaneous dose.
It is a type III, well-tolerated interferon (IFN) that induces immune responses required for developing host protection during viral infections.
In May 2021, Eiger announced that Peginterferon Lambda will be added to the Phase III TOGETHER platform study of Covid-19 outpatients in Brazil.
A multi-centre, investigator-sponsored, randomised, placebo-controlled Phase III study, TOGETHER is analysing various drugs in newly diagnosed Covid-19 patients.
Clinical outcome comparing emergency room visits and/or hospitalisation in each active group to placebo is the trial’s primary goal.
Eiger noted that the trial will enrol up to 800 subjects into each arm, which will include patients who are at increased risk for developing complications due to disease progression.
Planned interim analyses for futility will also be conducted.
Eiger BioPharmaceuticals president and CEO David Cory said: “Effective treatments are desperately needed for newly diagnosed Covid-19 outpatients that can be quickly and easily administered upon diagnosis, outside the hospital.
“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, which remain an ongoing concern with approved monoclonal antibodies and vaccines.”
IFN lambda has demonstrated the ability to hinder viral replication without developing cytokine storms, the company noted.
Lambda is currently being developed by Eiger to treat hepatitis delta virus (HDV) infection.
The drug has so far been given to more than 3,000 subjects in 23 trials of HDV, hepatitis C, hepatitis B, and Covid-19.
The US Food and Drug Administration (FDA) and European Medicines Agency (EMA) granted orphan drug status to Lambda.
The drug also received fast track and breakthrough therapy status from FDA for HDV.