Anti-SARS-CoV-2 hyperimmune globulin therapy - Grifols
Alternative Names: Anti-coronavirus hIVIG - Grifols; Anti-coronavirus hyperimmune intravenous immunoglobulin - Grifols; anti-COVID-19 immune globulin 20% - Grifols; Anti-SARS-CoV-2 immunoglobulin - Grifols; C19-IG 20% - GrifolsLatest Information Update: 10 Mar 2022
At a glance
- Originator Grifols
- Developer Grifols; National Institute of Allergy and Infectious Diseases; National Institutes of Health (USA)
- Class Antivirals; Immunoglobulins; Polyclonal antibodies
- Mechanism of Action Immunomodulators
-
Orphan Drug Status
No
Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.
- New Molecular Entity No
- Available For Licensing Yes
Highest Development Phases
- Phase III COVID 2019 infections
Most Recent Events
- 09 Feb 2022 Grifols terminates a phase III trial in COVID-2019 infections in Spain due to futile results (SC,Infusion) (NCT04847141)
- 28 Apr 2021 Phase-III clinical trials in COVID-2019 infections in Spain (SC,Infusion) in April 2021 (NCT04847141) (EudraCT2021-000269-34)
- 22 Apr 2021 Grifols plans a phase III trial in COVID-2019 infections (SC) in April 2021 (NCT04847141) (EudraCT2021-000269-34)
Development Overview
Introduction
Anti-SARS-CoV-2 hyperimmune globulin therapy is being developed by Grifols in collaboration with United States Biomedical Advanced Research Development Authority (BARDA), the National Institutes of Health, the Food and Drug Administration (FDA) and other Federal public health agencies for the treatment of COVID-2019 infections. The polyclonal antibodies candidate is based on Grifols' immunoglobulin Gamunex®-C and will use plasma from convalescent COVID-19 patients. It is a highly specific, pure therapy that provides a high and consistent concentration of neutralising antibodies against the SARS-CoV-2 virus. Clinical development is underway in the US, the UK, Mexico, and Spain.
Grifols is exploring strategic collaborations for hyperimmune globulin therapy in Europe [1] .
Company Agreements
In March 2020, Grifols entered into a collaboration with the United States Biomedical Advanced Research Development Authority (BARDA), the Food and Drug Administration (FDA), the National Institutes of Health (NIH) and other Federal public health agencies to collect plasma from convalescent COVID-19 patients and to process this specific plasma into a hyperimmune globulin to support the preclinical and clinical studies to determine if anti-SARS-CoV-2 hyperimmune globulin therapy to treat COVID-19 disease. Grifols will volunteer its expertise and resources in the areas of plasma collection using its network of FDA-approved plasma donor centers; test and qualify donors in conjunction with other health agencies, to process plasma into hyperimmune globulin in its purpose-built facility. This unique collaboration will provide the opportunity to validate a therapy that, if proven effective, can be used today in the face of the COVID-19 pandemic and for future outbreaks of novel emerging viruses. [2]
Key Development Milestones
In February 2022, Grifols terminated a phase III trial which was designed to compare the efficacy of anti-COVID-19 immune globulin (human) 20% (C19-IG 20%) (two doses) as compared with placebo with regard to the percentage of asymptomatic patients who remain asymptomatic, that is, who do not develop symptomatic COVID-19 infection through Day 14 as per the protocol defined criteria (NCT04847141; EudraCT2021-000269-34; GC2010). The company terminated the trial due to futile outcome. The double-blind, multicentre, parallel, prospective, randomised trial was initiated in April 2021 and enrolled 465 patients in Spain [3] .
In January 2021, Grifols was anticipating to initiate a clinical trial in Spain to evaluate the safety and efficacy of anti-SARS-CoV-2 hyperimmune globulin therapy in February 2021. The trial intends to enrol 800 participants who are asymptomatic but tested positive for the SARS-CoV-2 virus [4] .
In April 2021, Grifols announced the topline data for the phase III ITAC (INSIGHT-013) trial to evaluate the safety, tolerability and efficacy of anti-coronavirus hyperimmune intravenous immunoglobulin (hIVIG) versus placebo, along with remdesivir [see adis profile 800043325] as standard of care, in adult patients hospitalised for COVID-19 and have had symptoms for 12 days or fewer without life-threatening organ dysfunction or end-organ failure (INSIGHT013; EudraCT2020-002542-16; INSIGHT 013; NCT04546581). The trial did not meet its primary endpoint of ordinal outcome based on the patients' clinical status on Day 7 in each group, with seven mutually exclusive categories ranging from no limiting symptoms due to COVID-19, to death, with statistically significant results. The University of Minnesota, the National Institute of Allergy and Infectious Diseases (NIAID), and the National Institutes of Health (NIH) had initiated the double-blind, placebo-controlled, randomised, adaptive phase III trial in September 2020 [5] . The Inpatient Treatment with Anti-Coronavirus Immunoglobulin (ITAC) trial enrolled 593 patients in the US, Mexico, the UK and 15 other countries in Africa, Asia, Europe, North America and South America [6] . Emergent BioSolutions [see adis profile 800057829] , Grifols and, CSL Behring with Takeda [see adis profile 800057734] will provide anti-coronavirus hIVIG for the trial. In October 2020, NIAID announced that primary analysis was planned after all participants finish 28 days of follow-up. An independent data and safety monitoring board (DSMB) will review interim safety and efficacy data to ensure patient well-being and safety as well as study integrity [7] .
As of July 2020, Grifols is working on a clinical study of hyperimmune globulin using convalescent plasma collected in Europe [8] .
As of March 2020, Grifols is working on a clinical trial with inactivated plasma from recovered patients (methylene blue) through a collaboration with select donation centers and public hospitals for the treatment of COVID-2019 infections in Spain [2] .
Financing information
As of October 2020, the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, was sponsoring and funding the phase III ITAC trial [see above] [7] .
Drug Properties & Chemical Synopsis
- Route of administration IV, Parenteral, SC
- Formulation Infusion
- 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 | asymptomatic patients | - | Phase III | Spain | SC / Infusion | Grifols | 28 Apr 2021 |
| COVID 2019 infections | - | - | Phase III | USA | IV / Infusion | Grifols, National Institute of Allergy and Infectious Diseases | 08 Oct 2020 |
| COVID 2019 infections | - | - | Phase III | Mexico, United Kingdom | IV / Infusion | Grifols, National Institutes of Health (USA) | 08 Oct 2020 |
Commercial Information
Involved Organisations
| Organisation | Involvement | Countries |
|---|---|---|
| Grifols | Originator | Spain |
| Grifols | Owner | Spain |
| National Institutes of Health (USA) | Collaborator | USA |
| National Institute of Allergy and Infectious Diseases | Collaborator | USA |
| Food and Drug Administration | Collaborator | USA |
| Biomedical Advanced Research and Development Authority | Collaborator | USA |
Licensing Availability
| Licensing Organisation | Available Indication | Available Phase | Region | Date |
|---|---|---|---|---|
| Grifols | - | Unspecified | Europe | 11 Jun 2020 |
Scientific Summary
Therapeutic Trials
Phase III:
Topline results of the phase III ITAC (INSIGHT-013) trial in hospitalised adult patients hospitalised for COVID-2019 demonstrated that the trial did not meet its primary endpoint of ordinal outcome based on the patients' clinical status at Day 7 in each group, with seven mutually exclusive categories ranging from no limiting symptoms due to COVID-2019, to death, with statistically significant results [5] [6] .
Future Events
| Expected Date | Event Type | Description | Updated |
|---|---|---|---|
| 28 Feb 2021 | Trial Update | Grifols plans a clinical trial for COVID-2019 infections in Spain in February 2021 (SC) [4] | 10 Mar 2022 |
| 31 Jul 2020 | Trial Update | Grifols plans a clinical study of hyperimmune globulin for COVID-2019 infections in USA (Parenteral) in July 2020 [1] | 16 Jun 2020 |
Development History
| Event Date | Update Type | Comment |
|---|---|---|
| 09 Feb 2022 | Trial Update | Grifols terminates a phase III trial in COVID-2019 infections in Spain due to futile results (SC,Infusion) (NCT04847141) Updated 10 Mar 2022 |
| 28 Apr 2021 | Phase Change - III | Phase-III clinical trials in COVID-2019 infections in Spain (SC,Infusion) in April 2021 (NCT04847141) (EudraCT2021-000269-34) Updated 27 May 2021 |
| 22 Apr 2021 | Trial Update | Grifols plans a phase III trial in COVID-2019 infections (SC) in April 2021 (NCT04847141) (EudraCT2021-000269-34) Updated 22 Apr 2021 |
| 02 Apr 2021 | Scientific Update | Topline efficacy data from phase III ITAC trial in COVID-2019 infections released by Grifols [5] Updated 06 Apr 2021 |
| 18 Jan 2021 | Trial Update | Grifols plans a clinical trial for COVID-2019 infections in Spain in February 2021 (SC) [4] Updated 10 Mar 2022 |
| 08 Oct 2020 | Phase Change - III | Phase-III clinical trials in COVID-2019 infections in Mexico and USA (IV) [7] (NCT04546581) Updated 25 Oct 2020 |
| 30 Sep 2020 | Phase Change - III | Phase-III clinical trials in COVID-2019 infections in United Kingdom (IV) [7] (EudraCT-2020-002542-16) Updated 25 Oct 2020 |
| 29 Jul 2020 | Trial Update | Grifols plans a clinical study of hyperimmune globulin for COVID-2019 infections in the Europe [8] Updated 30 Jul 2020 |
| 11 Jun 2020 | Licensing Status | Anti-SARS-CoV-2 hyperimmune globulin therapy - Grifols is available for licensing in Europe as of 11 Jun 2020. www.grifols.com Updated 16 Jun 2020 |
| 11 Jun 2020 | Phase Change - Preclinical | Preclinical trials in COVID-2019 infections in Spain (Parenteral) before June 2020 [1] Updated 16 Jun 2020 |
| 11 Jun 2020 | Phase Change - Preclinical | Preclinical trials in COVID-2019 infections in USA (Parenteral) before June 2020 [1] Updated 16 Jun 2020 |
| 11 Jun 2020 | Trial Update | Grifols plans a clinical study of hyperimmune globulin for COVID-2019 infections in USA (Parenteral) in July 2020 [1] Updated 16 Jun 2020 |
| 25 Mar 2020 | Licensing Status | Grifols entered into collaboration with Biomedical Advanced Research Development Authority and the Food and Drug Administration for the treatment of COVID-2019 infections [2] Updated 27 Mar 2020 |
| 25 Mar 2020 | Phase Change | Early research in COVID-2019 infections in Spain (Parenteral) [2] Updated 27 Mar 2020 |
| 25 Mar 2020 | Phase Change | Early research in COVID-2019 infections in USA (Parenteral) [2] Updated 27 Mar 2020 |
References
-
Grifols starts production of its hyperimmune immunoglobulin as a potential passive immune therapy against COVID-19.
Media Release -
Grifols Announces Formal Collaboration with US Government to Produce the First Treatment Specifically Targeting COVID-19.
Media Release -
A Multicenter, Randomized, Double-blind, Parallel Group Study to Evaluate the Safety and Efficacy of Anti-COVID-19 Immune Globulin (Human) 20% (C19-IG 20%) Versus Placebo in Asymptomatic Ambulatory Outpatients With Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Infection
ctiprofile -
Grifols begins clinical trial of a new treatment that would provide immediate immunity against COVID-19.
Media Release -
Grifols announces topline data from NIAID Phase 3 ITAC trial (INSIGHT-013) evaluating hyperimmune globulins as a treatment for hospitalized patients with COVID-19.
Media Release -
An International Multicenter, Adaptive, Randomized Double-Blind, Placebo-Controlled Trial of the Safety, Tolerability and Efficacy of Anti-Coronavirus Hyperimmune Intravenous Immunoglobulin for the Treatment of Adult Hospitalized Patients at Onset of Clinical Progression of COVID-19
ctiprofile -
NIH clinical trial testing hyperimmune intravenous immunoglobulin plus remdesivir to treat COVID-19 Begins.
Media Release -
Grifols delivers first manufactured batches of its anti-SARS-CoV-2 hyperimmune globulin for clinical trials.
Media Release
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