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September 21, 2021

Eiger obtains DSMB approval to progress Phase III Covid-19 therapy trial

The recommendation follows an interim futility analysis conducted by the panel on a sample size of 453 subjects.

Eiger BioPharmaceuticals has reported that the Data Safety Monitoring Board (DSMB) recommended continuing subject enrolment in the Peginterferon Lambda arm of the Phase III TOGETHER platform clinical trial in Covid-19 outpatients.

Licensed from Bristol-Myers Squibb, Peginterferon Lambda is a type III interferon (IFN) that induces the immune responses vital for developing host protection during viral infections.

The move comes after the per-protocol interim futility analysis conducted on a sample size of 453 patients who were randomised into a 1:1 ratio to receive either the treatment or placebo.

Eiger noted that the multicentre, investigator-sponsored, randomised, placebo-controlled adaptive platform Phase III trial is assessing various therapies in freshly diagnosed Covid-19 outpatients who are at increased risk.

The Peginterferon Lambda group plans to enrol up to 800 subjects who are at increased risk of developing complications from Covid-19 disease progression.

The clinical outcome comparing emergency setting visits and/or hospitalisation in each active group versus placebo is the primary endpoint of the trial.

For the trial, the DSMB offers independent advice. It has earlier suspended five other treatments on detecting futility, Eiger noted.

The TOGETHER study is currently enrolling subjects at 12 trial centres in Brazil.

Eiger BioPharmaceuticals president and CEO David Cory said: “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.”

In July 2021, Eiger dosed the first subjects in the trial of Peginterferon Lambda for Covid-19 in outpatient settings.

The company is also developing Peginterferon Lambda to treat hepatitis delta virus (HDV) infection.

Peginterferon Lambda has so far been administered to more than 3,000 participants in 23 clinical trials of Hepatitis B, Hepatitis C, HDV and Covid-19.

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