Benzinga | May 3, 2021 08:03AM EDT

Eiger BioPharmaceuticals Announces Peginterferon Lambda To Added To Multi-Center Phase 3 TOGETHER COVID-19 Study In Brazil

Eiger BioPharmaceuticals, Inc. (NASDAQ:EIGR), a commercial-stage biopharmaceutical company focused on the development and commercialization of targeted therapies for serious rare and ultra-rare diseases, today announced that Peginterferon Lambda (Lambda) will be added to the ongoing, multi-center, Phase 3 TOGETHER platform study in outpatients with COVID-19.

TOGETHER is an ongoing, multi-center, investigator-sponsored, randomized, placebo-controlled Phase 3 study evaluating multiple therapeutics in newly diagnosed, non-hospitalized patients with COVID-19, and will now include an investigational arm of Lambda as a single subcutaneous dose. The primary endpoint is a clinical outcome comparing emergency room visits and/or hospitalization in each active arm versus placebo. 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. The TOGETHER platform study is currently recruiting at eleven sites in Brazil and may expand to include a site in Toronto, Canada.

"The COVID-19 pandemic continues to be a global public health emergency, and outpatient treatments that can be quickly and efficiently administered to newly diagnosed SARS-CoV-2 patients are desperately needed with a goal of reducing COVID-19 complications," said Edward Mills, PhD, Principal Investigator, Professor of Health Research Methods, Evidence, and Impact at McMaster University, Vancouver, Canada, who is leading the study with Gilmar Reis, MD, PhD, Co-Investigator, Associate Professor of Medicine, Pontifical Catholic University of Minas Gerais, Brazil. "The Phase 2 data generated with Lambda, as a single subcutaneous injection, in newly diagnosed outpatients with mild or moderate COVID-19, supports exploration of Lambda as a promising potential outpatient therapy."

"Resistance due to variants or new strains of SARS-CoV-2 is an ongoing concern with approved monoclonal antibodies and vaccines," said David Cory, President and Chief Executive Officer at Eiger. "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."

For more information about the TOGETHER platform study (NCT04727424), please click here.