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COVID-2019 immune globulins - Emergent BioSolutions

Drug Profile

COVID-2019 immune globulins - Emergent BioSolutions

Alternative Names: Anti-SARS-CoV-2 immune globulin intravenous (Human); COVID-HIG

Latest Information Update: 29 May 2020

At a glance

  • Originator Emergent BioSolutions
  • Class Antivirals; Immunoglobulins; Polyclonal antibodies
  • Mechanism of Action Immunomodulators
  • Orphan Drug Status

    Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.

    No
  • New Molecular Entity No

Highest Development Phases

  • Preclinical COVID 2019 infections

Most Recent Events

  • 29 May 2020 Preclinical trials in COVID-2019 infections (Prevention) in USA (Parenteral), prior to May 2020 (Emergent BioSolutions pipeline, May 2020)
  • 29 May 2020 Preclinical trials in COVID-2019 infections in USA (Parenteral), prior to May 2020 (Emergent BioSolutions pipeline, May 2020)
  • 03 Apr 2020 Emergent solutions receives funding from Biomedical Advanced Research and Development Authority (BARDA) to support development of COVID-2019 immune globulins .

Development Overview

Introduction

Purified gamma globulin (IgG), containing polyclonal antibodies, designated as COVID HIG, is being developed by Emergent BioSolutions, for the treatment and prevention of severe COVID-2019 infections. The company has utilised its hyperimmune platform, which allows the isolation of purified gamma globulin containing polyclonal antibodies to specific antigens of SARS-CoV-2 from humans. Hyperimmunes are polyclonal antibodies derived from plasma that leverage the immune response in human and can provide protection from infection. Preclinical development is underway in the US.

Key Development Milestones

As of May 2020, Emergent BioSolutions is conducting preclinical trials of COVID HIG, for the prevention and treatment of severe COVID-2019 infections (Emergent BioSolutions pipeline, May 2020).

In March 2020, Emergent BioSolutions reported initiation of plasma collection from humans in order to isolate and manufacture antibodies against SARS-CoV-2 virus [1] .

Financing information

In April 2020, Emergent solutions received $US14.5 million from the Biomedical Advanced Research and Development Authority (BARDA) to support development of COVID-2019 immune globulins [2] .

Drug Properties & Chemical Synopsis

  • Route of administration Parenteral
  • Formulation unspecified
  • Class Antivirals, Immunoglobulins, Polyclonal antibodies
  • Mechanism of Action Immunomodulators
  • WHO ATC code

    J06B (Immunoglobulins)

  • EPhMRA code

    J6H (Specific Immunoglobulins - Antiviral)

Development Status

Summary Table

Indication Qualifier Patient Segment Phase Countries Route / Formulation Developers Event Date
COVID 2019 infections - - Preclinical USA Parenteral / unspecified Emergent BioSolutions 29 May 2020
COVID 2019 infections - Prevention Preclinical USA Parenteral / unspecified Emergent BioSolutions 29 May 2020

Commercial Information

Involved Organisations

Organisation Involvement Countries
Emergent BioSolutions Originator USA
Emergent BioSolutions Owner USA
Biomedical Advanced Research and Development Authority Funder USA
National Institute of Allergy and Infectious Diseases Collaborator USA

Future Events

Expected Date Event Type Description Updated
30 Sep 2020 Trial Update Emergent BioSolutions plans a clinical trial for COVID-2019 infections in the third quarter of 2020 (Parenteral) [1] 24 Mar 2020

Development History

Event Date Update Type Comment
29 May 2020 Phase Change - Preclinical Preclinical trials in COVID-2019 infections (Prevention) in USA (Parenteral), prior to May 2020 (Emergent BioSolutions pipeline, May 2020) Updated 29 May 2020
29 May 2020 Phase Change - Preclinical Preclinical trials in COVID-2019 infections in USA (Parenteral), prior to May 2020 (Emergent BioSolutions pipeline, May 2020) Updated 29 May 2020
03 Apr 2020 Licensing Status Emergent solutions receives funding from Biomedical Advanced Research and Development Authority (BARDA) to support development of COVID-2019 immune globulins [2] . Updated 08 Apr 2020
11 Mar 2020 Trial Update Emergent BioSolutions plans a clinical trial for COVID-2019 infections in the third quarter of 2020 (Parenteral) [1] Updated 24 Mar 2020
11 Mar 2020 Phase Change Early research in COVID-2019 infections (Prevention) in USA (Parenteral) [1] Updated 19 Mar 2020
11 Mar 2020 Phase Change Early research in COVID-2019 infections in USA (Parenteral) [1] Updated 19 Mar 2020

References

  1. Emergent BioSolutions Initiates Development of Plasma-Derived Product Candidates for the Treatment and Prevention of Coronavirus Disease.

    Media Release
  2. Emergent BioSolutions Partners with U.S. Government for Comprehensive Response to Expedite Development of Plasma-Derived Therapy for COVID-19.

    Media Release
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