Eiger BioPharmaceuticals, Inc., a commercial-stage biopharmaceutical company focused on the development of innovative therapies to treat and cure Hepatitis Delta Virus (HDV) and other serious rare diseases, announced that the Data Safety Monitoring Board (DSMB) for the Phase 3 TOGETHER study has conducted a second interim futility analysis and recommended continuation of the study. This analysis was based on a sample size of 1,003 patients, randomized to active or placebo. The primary endpoint compares number of extended emergency setting visits, hospitalizations, and/or deaths in treated patients versus placebo. TOGETHER is expected to enroll up to 1,600 patients at high risk for developing complications from progression of COVID-19.
“We are pleased that the DSMB has now completed a second interim futility analysis on a larger sample of Peginterferon Lambda treated patients and recommended to continue enrollment,” said Edward Mills, PhD, Principal Investigator, Professor of Health Research Methods, Evidence, and Impact at McMaster University Hamilton, 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 treatments with novel mechanisms that can be easily administered to newly diagnosed patients are urgently needed.”
“Peginterferon Lambda stimulates immune responses critical to innate defenses with a mechanism of action agnostic to variants of SARS-CoV-2 and resistance concerns with other treatments,” said David Cory, President and Chief Executive Officer at Eiger. “A single subcutaneous injection of Peginterferon Lambda administered to newly diagnosed COVID-19 patients may reduce complications and prevent hospitalizations, with or without other treatments. We look forward to reporting results of the TOGETHER study.”
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. Peginterferon Lambda is currently the only therapeutic being investigated in TOGETHER.