View all newsletters
Receive our newsletter – data, insights and analysis delivered to you
  1. News
December 16, 2021updated 07 Jan 2022 7:12am

Eiger obtains DSMB advice to continue Phase III Covid-19 therapy trial

The trial plans to enrol approximately 1,600 Covid-19 patients, with recruitment progressing at 12 trial centres in Brazil.

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.

Free Whitepaper
img

Unlocking the clinical trial potential of Africa

Ongoing improvements around infrastructure, continued investment, and being home to one of the world’s largest working age populations, means that Africa’s role in the clinical trials market has transformed. In this whitepaper, Oximio outlines the dynamics of today’s clinical trial market in Africa, including the key challenges the region is facing and how sponsors can overcome them to unlock the continent’s growing potential.
by Oximio
Enter your details here to receive your free Whitepaper.

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.

Related Companies

Free Whitepaper
img

Unlocking the clinical trial potential of Africa

Ongoing improvements around infrastructure, continued investment, and being home to one of the world’s largest working age populations, means that Africa’s role in the clinical trials market has transformed. In this whitepaper, Oximio outlines the dynamics of today’s clinical trial market in Africa, including the key challenges the region is facing and how sponsors can overcome them to unlock the continent’s growing potential.
by Oximio
Enter your details here to receive your free Whitepaper.

NEWSLETTER Sign up Tick the boxes of the newsletters you would like to receive. Key drug pipeline and competitive landscape changes based on the latest clinical activity, sent every Tuesday. Curated analysis and data-driven insights on clinical trials strategy and operations, sent every Thursday. The pharmaceutical industry's most comprehensive news and information delivered every month.
I consent to GlobalData UK Limited collecting my details provided via this form in accordance with the Privacy Policy
SUBSCRIBED

THANK YOU

Thank you for subscribing to Clinical Trials Arena