Emergent BioSolutions Inc. is one of four companies collaborating to provide hyperimmune globulin products for a new federal clinical trial that will test the safety, tolerability and efficacy of a combination treatment regimen for COVID-19.
The regimen consists of the antiviral remdesivir plus a highly concentrated solution of antibodies that neutralize SARS-CoV-2, the virus that causes COVID-19, according to the National Institute of Allergy and Infectious Diseases (NIAID), the division of the National Institutes of Health (NIH) that is sponsoring and funding the Phase 3 trial known as Inpatient Treatment with Anti-Coronavirus Immunoglobulin, or ITAC. Remdesivir is currently recommended by NIAID for treating certain hospitalized patients with COVID-19.
“Emergent is proud to continue our partnership with NIAID/NIH and the Biomedical Advanced Research and Development Authority (BARDA) to advance potential therapeutic solutions for COVID-19 in hospitalized patients,” said Dr. Laura Saward, senior vice president and head of the therapeutics business unit at Emergent BioSolutions. “We are drawing from decades of experience developing treatments on our well-established hyperimmune platform to address this serious public health threat.”
The antibody solution being tested in the ITAC trial is anti-coronavirus hyperimmune intravenous immunoglobulin (hIVIG), which comes from the liquid portion of blood, or plasma, donated by healthy people who have recovered from COVID-19.
Patients in the randomized controlled clinical trial will receive infusions of either a placebo or one of four hyperimmune globulin (HIG) products — which includes Emergent’s COVID-HIG — with a background therapy of remdesivir being used in all groups. None of the participants nor any of the study team members will know who is receiving which treatment regimen, NIH said.
Emergent’s COVID-HIG is being developed as a potential treatment for hospitalized patients, as well as high-risk, acute symptomatic patients, with $14.5 million in funding from BARDA, according to the Gaithersburg, Md.-based company, while a $34.6 million grant from the U.S. Department of Defense will allow COVID-HIG to also be evaluated as a potential post-exposure prophylaxis therapeutic for people at high risk of exposure to SARS-CoV-2, such as front-line healthcare workers and military service members.
Emergent earlier this year submitted the Investigational New Drug application to the U.S. Food and Drug Administration (FDA) for its COVID-HIG to be used in the ITAC study. The FDA in August cleared the product’s use in the trial.
According to NIH, the ITAC investigators hypothesize that giving people anti-coronavirus hIVIG at the onset of COVID-19 symptoms could help the natural antibody response to SARS-CoV-2 and reduce the risk of more serious illness and death.
“Finding safe and effective treatments for COVID-19 is absolutely critical,” said NIAID Director Dr. Anthony Fauci. “The ITAC trial will examine whether adding anti-coronavirus hIVIG to a remdesivir regimen can give the immune system a needed boost to suppress SARS-CoV-2 early in the course of illness, nipping the infection in the bud.”
The ITAC study team will enroll 500 hospitalized adults ages 18 or older from across U.S. and international clinical trial sites. The participants will have had COVID-19 symptoms for 12 days or fewer without having any life-threatening organ dysfunction or organ failure, according to an NIH statement released on Oct. 8.
The main goal of the ITAC trial is to compare the health status of participants in the combination treatment group with participants in the remdesivir-only group on day seven. ITAC study participants will be followed for 28 days and if the trial goes to completion, the primary analysis will be completed after all participants finish 28 days of follow-up, according to the NIH statement.
Emergent BioSolutions is collaborating with three other companies to provide anti-coronavirus hIVIG for the ITAC trial: Grifols S.A. of Barcelona; CSL Behring of King of Prussia, Pa.; and Tokyo-based Takeda Pharmaceuticals.
Leading the ITAC trial is Protocol Chairman Dr. Mark Polizzotto, head of the Therapeutic and Vaccine Research Program at The Kirby Institute in the University of New South Wales, Sydney. The University of Minnesota is the coordinating center for the trial.