Emergent BioSolutions’ candidate part of federal trial for out-patient COVID-19 treatment

A plasma-derived COVID-19 candidate from Emergent BioSolutions Inc. is part of a late-stage federal study that will test the therapy as a potential outpatient treatment for people who are at high risk of developing severe disease, including adults 55 and older and those 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), which is part of the National Institutes of Health (NIH).

The study aims to evaluate the safety and efficacy of hyperimmune globulin products derived from the plasma of individuals who have recovered from COVID-19 and have developed neutralizing antibodies to SARS-CoV-2, the virus that causes COVID-19, Emergent said on Wednesday.

Specifically, the Emergent candidate to be tested — its investigational SARS-CoV-2 Immune Globulin Intravenous (Human) (COVID-HIG) plasma-derived therapy — is in development through funding from the U.S. Department of Health and Human Services’ Office of the Assistant Secretary for Preparedness and Response, and the Biomedical Advanced Research and Development Authority (BARDA).

“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,” said Dr. Laura Saward, an Emergent senior vice president and head of the company’s therapeutics business unit. “This earlier intervention has the potential to improve patient outcomes and keep people out of the hospital.”

Saward added that as a polyclonal product having many different types of antibodies, Emergent’s COVID-HIG “may also provide additional benefits against variants of concern as demonstrated by in vitro testing.”

The randomized controlled clinical trial will enroll roughly 800 patients across the United States and international clinical trial sites and will assign 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, according to a statement released by the Gaithersburg, Md.-based developer.

“Emergent is pleased to be working closely with NIAID/NIH and 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,” Saward said.

Emergent is one of two companies providing hyperimmune globulin products for the trial, which also 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, the company said.