Benzinga | Sep 28, 2020 08:08AM EDT

Eiger Announces Results Of Investigator Sponsored Study In Outpatients With Mild And Uncomplicated COVID-19; Says 'No difference was demonstrated in duration of SARS-CoV-2 viral shedding and time to symptom resolution when compared with placebo'

PALO ALTO, Calif., Sept.28, 2020 /PRNewswire/ --Eiger BioPharmaceuticals, Inc. (NASDAQ:EIGR), focused on the development and commercialization of targeted therapies for serious rare and ultra-rare diseases, today announced results of an investigator sponsored study of Peginterferon Lambda-1a (Lambda) in outpatients with mild and uncomplicated COVID-19.

The primary endpoint was duration of viral shedding, determined by time to first of two consecutive negative tests forSARS-CoV-2byqRT-PCR. The secondary endpoint was reducing duration of symptoms and hospitalization in patients with mild COVID-19. A total of 120 patients were randomized 1:1 to a single subcutaneous dose of Lambda or normal saline placebo. Patients were followed for 28 days.

No difference was demonstrated in duration of SARS-CoV-2 viral shedding and time to symptom resolution when compared with placebo. Median time to cessation of viral shedding in both groups was 7 days. Lambda was well-tolerated with few adverse events, which included elevated transaminases which self-resolved.

The study was co-led by Stanford University School of Medicine researchers Upinder Singh, MD, Professor of Medicine and Infectious Diseases and Geographic Medicine and Microbiology and Immunology, and Prasanna Jagannathan, MD, Assistant Professor of Medicine and Infectious Diseases.

"We now know that untreated patients with mild COVID-19 clear virus quickly. Published reports have demonstrated evidence of a therapeutic benefit of interferonsin hospitalized patients with more advanced COVID-19 disease," said Colin Hislop, MD, Senior Vice President of Clinical and Development Operations at Eiger. "We look forward to the results of the four on-going peginterferon lambda investigator sponsored studies in hospitalized patients with more advancedCOVID-19, as well as the prophylaxis study of exposed or at-risk patients."

"Lambda is in late stage development for the treatment of Hepatitis Delta Virus (HDV), the most severe form of human viral hepatitis, and HDV is our lead clinical program," said David Cory, President and CEO of Eiger. "We have previously generated positive results in two Phase 2 studies in HDV-infected patients and have concurrence with FDA and EMA on a single, Phase 3 study of Lambda monotherapy in patients infected with chronic HDV. We look forward to initiating this study."