Benzinga | Aug 25, 2021 06:34AM EDT

Emergent BioSolutions' COVID-19 Human Immune Globulin Product Candidate To Be Evaluated In NIH-Sponsored Phase 3 Clinical Trial Of Hyperimmune Intravenous Immunoglobulin For Outpatient Treatment Of COVID-19

* NIAID has initiated a Phase 3 clinical trial to evaluate the efficacy and safety of hyperimmune globulin products, including Emergent's COVID-19 Human Immune Globulin (COVID-HIG), for potential treatment of COVID-19 in adult patients at risk of progression to severe disease

GAITHERSBURG, Md., Aug. 25, 2021 (GLOBE NEWSWIRE) -- Emergent BioSolutions Inc. (NYSE:EBS) today announced the initiation of a Phase 3 clinical trial that will evaluate its investigational SARS-CoV-2 Immune Globulin Intravenous (Human) (COVID-HIG) plasma-derived therapy as a potential outpatient treatment for patients with coronavirus disease (COVID-19) that are at high risk of progression to severe disease, including adults 55 and older and those 18 and older who are immunocompromised.

The INSIGHT-012 clinical study called "Outpatient Treatment with Anti-Coronavirus Immunoglobulin (OTAC)" is sponsored by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH). The study will evaluate the safety and efficacy of hyperimmune globulin products derived from plasma of individuals who have recovered from COVID-19 and have developed neutralizing antibodies to SARS-CoV-2, the virus that causes COVID-19. The randomized controlled clinical trial assigns participants to receive infusions of either a placebo or one of two hyperimmune globulin products, including Emergent's COVID-HIG, in addition to standard of care in all groups.

"Emergent is pleased to be working closely with NIAID/NIH and the Biomedical Advanced Research and Development Authority (BARDA) to potentially fill an unmet need for COVID-19 therapeutics and for use with certain populations such as the immunocompromised or those who cannot receive vaccines," said Dr. Laura Saward, SVP and therapeutics business unit head at Emergent BioSolutions. "Treatment with COVID-HIG earlier in the COVID-19 disease course offers a window of intervention when viral replication is extensive but natural antibody response hasn't been generated yet. This earlier intervention has the potential to improve patient outcomes and keep people out of the hospital. As a polyclonal product with many different types of antibodies, COVID-HIG may also provide additional benefits against variants of concern as demonstrated by in vitro testing."

Emergent is one of two companies providing hyperimmune globulin products for the trial, which plans to enroll approximately 800 patients across U.S. and international clinical trial sites. The OTAC investigators will assess whether giving people anti-coronavirus hyperimmune globulin at the onset of COVID-19 symptoms could quickly augment the natural--and possibly delayed--antibody response to SARS-CoV-2, thereby potentially reducing the risk of more serious illness and death.

Emergent's COVID-HIG is being developed as a potential treatment for COVID-19 in the outpatient population and is being funded in whole or in part with federal funds from the Department of Health and Human Services, Office of the Assistant Secretary for Preparedness and Response, Biomedical Advanced Research and Development Authority under contract HHSO100201200004I, task order 75A50120F33006.

For more information about the OTAC trial, visit the posting on clinicaltrials.gov.

About Emergent BioSolutions' SARS-CoV-2 Immune Globulin Intravenous (Human) (COVID-HIG)

Hyperimmune globulin, also referred to as polyclonal antibodies, is a concentrated antibody product derived from the antibody-rich plasma of people who were previously infected with and recovered from an illness, in this case, COVID-19 caused by the virus SARS-CoV-2. In order to produce plasma-derived products, plasma is collected from a pool of human donors and then manufactured, or fractionated, into specialized therapeutic products. COVID-HIG is an investigational product that is not approved by the FDA and its safety and effectiveness have not been established.