Biopharmaceutical company Eiger BioPharmaceuticals Inc (Nasdaq:EIGR) stated on Tuesday that Peginterferon Lambda (Lambda) will be included to the ongoing, multi-center, Phase 3 TOGETHER platformme study in outpatients with COVID-19 in Brazil.
The company said TOGETHER is an ongoing, multi-centre, investigator-sponsored, randomized, placebo-controlled Phase 3 study evaluating multiple therapeutics in newly diagnosed, non-hospitalized patients with COVID-19.
TOGETHER will now include an investigational arm of Lambda as a single subcutaneous dose. The TOGETHER platform study is currently recruiting at 11 sites in Brazil and may expand to include a site in Toronto, Canada. Each arm targets enrollment of up to 800 patients at high risk for developing complications from progression of COVID-19, with planned interim analyses for futility in each arm.
According to the company, the primary endpoint of TOGETHER is a clinical outcome comparing emergency room visits and/or hospitalization in each active arm versus placebo.
Lambda is a well-characterised, 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. Lambda targets type III IFN receptors. IFN lambda receptors are largely restricted to cells and tissues of epithelial origin, including respiratory epithelial cells, concluded the company.
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