Benzinga | Sep 20, 2021 08:07AM EDT

Eiger BioPharmaceuticals Announces Interim Analysis And Continuation Of Dosing Of Peginterferon Lambda In Phase 3 TOGETHER Study Of Newly Diagnosed COVID-19 Outpatients

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 the Data Safety Monitoring Board (DSMB) recommended that investigators continue enrollment of the Peginterferon Lambda arm in the Phase 3 TOGETHER platform study. The per protocol interim futility analysis was based on a sample size of 453 patients, randomized 1:1 active treatment to placebo.

TOGETHER is a multi-center, investigator-sponsored, randomized, placebo-controlled adaptive platform Phase 3 study evaluating therapeutics in newly diagnosed, high-risk, non-hospitalized patients with COVID-19. The primary endpoint is a clinical outcome comparing emergency setting visits and/or hospitalization in each active arm versus placebo. The DSMB provides independent oversight for the trial and has previously discontinued five other therapeutics due to observed futility. The Peginterferon Lambda arm targets enrollment of up to 800 patients at high risk for developing complications from progression of COVID-19. The TOGETHER platform study is currently recruiting at twelve sites in Brazil.

"We are pleased that the DSMB has recommended to continue enrolling the Peginterferon Lambda arm in the TOGETHER study," 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 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."

"Resistance due to variants or new strains of SARS-CoV-2 is an ongoing concern with approved treatments as well as vaccines," said David Cory, President and Chief Executive Officer at Eiger. "Peginterferon Lambda stimulates immune responses that we believe are critical for the development of host protection during viral infections and may be ideal for addressing variants of SARS-CoV-2. Peginterferon Lambda's mechanism of action is agnostic to arising variants, and as such we believe may be ideally suited to treat newly diagnosed COVID-19 outpatients as a single subcutaneous injection. We look forward to reporting additional results in the future."

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