Eiger BioPharmaceuticals has received a recommendation from the Data Safety Monitoring Board (DSMB) to continue the Phase III TOGETHER clinical trial of Peginterferon Lambda without any changes.
The advice comes after DSMB carried out a second interim futility assessment on a sample size of 1,003 subjects randomised to receive the treatment or placebo.
The DSMB, which offers independent trial insight, previously recommended discontinuing five other therapies due to futility.
A type III interferon (IFN), Peginterferon Lambda induces immune responses required to develop host protection at the time of viral infections.
In 2016, Eiger obtained global rights to the therapy from Bristol-Myers Squibb.
The investigator-sponsored, multicentre, randomised, placebo-controlled adaptive platform trial is assessing Peginterferon Lambda in recently diagnosed Covid-19 non-hospitalised patients who are at greater risk.
It will enrol nearly 1,600 subjects with recruitment underway at 12 trial centres in Brazil.
Participants will be randomised to receive Peginterferon Lambda or a placebo.
The number of emergency setting visits, hospital admission and/or mortality through day 28 is the primary goal of the trial.
Eiger president and CEO David Cory said: “Peginterferon Lambda stimulates immune responses critical to innate defences with a mechanism of action agnostic to variants of SARS-CoV-2 and resistance concerns with other treatments.
“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.”
This July, the company dosed the first Covid-19 patients in the Phase III TOGETHER trial of Peginterferon Lambda in outpatient settings.