View all newsletters
Receive our newsletter - data, insights and analysis delivered to you
  1. News
July 7, 2021updated 12 Jul 2022 11:06am

Eiger starts dosing in Phase III Covid-19 drug trial in outpatients

Licenced from Bristol-Myers Squibb, IFN lambda can potentially hinder viral replication without developing cytokine storms.

Eiger BioPharmaceuticals has dosed the first subjects in the Phase III TOGETHER platform trial of its investigational agent, Peginterferon Lambda, for Covid-19 in outpatient settings.

Free Case Study
img

Direct-to-Patient Trials: How IRT Plays an Important Role in Bellerophon's Direct-to-Patient Trials

As the industry strengthens its focus on patient centricity, Direct-to-Patient clinical trials have emerged as a popular trial design that have the potential to increase patient recruitment and retention. IRT plays a crucial role in the success of a Direct-to-Patient trial. Because drug supplies are being managed and shipped from distribution facilities directly to patients’ homes, a sponsor must have a high-quality system in place to accurately track the chain of custody, ensure patient-blinding and handle other logistical challenges. What You Will Learn Benefits and challenges associated with the Direct-to-Patient model Bellerophon's top considerations when implementing this trial design How IRT can equip study teams to successfully track chain of custody, ensure patient blinding, and handle logistical challenges
by Suvoda
Enter your details here to receive your free Case Study.

Licenced from Bristol-Myers Squibb, Lambda is administered as a single subcutaneous dose.

It is a type III, well-tolerated interferon (IFN) that induces immune responses required for developing host protection during viral infections.

In May 2021, Eiger announced that Peginterferon Lambda will be added to the Phase III TOGETHER platform study of Covid-19 outpatients in Brazil.

A multi-centre, investigator-sponsored, randomised, placebo-controlled Phase III study, TOGETHER is analysing various drugs in newly diagnosed Covid-19 patients.

Clinical outcome comparing emergency room visits and/or hospitalisation in each active group to placebo is the trial’s primary goal.

Eiger noted that the trial will enrol up to 800 subjects into each arm, which will include patients who are at increased risk for developing complications due to disease progression.

Planned interim analyses for futility will also be conducted.

Eiger BioPharmaceuticals president and CEO David Cory said: “Effective treatments are desperately needed for newly diagnosed Covid-19 outpatients that can be quickly and easily administered upon diagnosis, outside the hospital.

“Lambda stimulates immune responses that are critical for the development of host protection during viral infections and may be ideal for addressing variants of SARS-CoV-2, which remain an ongoing concern with approved monoclonal antibodies and vaccines.”

IFN lambda has demonstrated the ability to hinder viral replication without developing cytokine storms, the company noted.

Lambda is currently being developed by Eiger to treat hepatitis delta virus (HDV) infection.

The drug has so far been given to more than 3,000 subjects in 23 trials of HDV, hepatitis C, hepatitis B, and Covid-19.

The US Food and Drug Administration (FDA) and European Medicines Agency (EMA) granted orphan drug status to Lambda.

The drug also received fast track and breakthrough therapy status from FDA for HDV.

Related Companies

Free Case Study
img

Direct-to-Patient Trials: How IRT Plays an Important Role in Bellerophon's Direct-to-Patient Trials

As the industry strengthens its focus on patient centricity, Direct-to-Patient clinical trials have emerged as a popular trial design that have the potential to increase patient recruitment and retention. IRT plays a crucial role in the success of a Direct-to-Patient trial. Because drug supplies are being managed and shipped from distribution facilities directly to patients’ homes, a sponsor must have a high-quality system in place to accurately track the chain of custody, ensure patient-blinding and handle other logistical challenges. What You Will Learn Benefits and challenges associated with the Direct-to-Patient model Bellerophon's top considerations when implementing this trial design How IRT can equip study teams to successfully track chain of custody, ensure patient blinding, and handle logistical challenges
by Suvoda
Enter your details here to receive your free Case Study.

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