- NIAID has initiated a Phase 3 clinical trial to evaluate the safety, tolerability, and efficacy of hyperimmune globulin products, including Emergent's COVID-19 Human Immune Globulin (COVID-HIG), as a potential treatment in adult patients hospitalized with COVID-19
- Emergent is planning additional clinical trials to evaluate COVID-HIG for potential use in other patient populations or individuals at high risk of exposure
GAITHERSBURG, Md., Oct. 08, 2020 (GLOBE NEWSWIRE) -- Emergent BioSolutions Inc. (NYSE:EBS) today announced the initiation of the Phase 3 clinical trial that will evaluate plasma-derived therapy COVID-HIG as a potential treatment for hospitalized patients with coronavirus disease (COVID-19). The INSIGHT-013 clinical study called "Inpatient Treatment with Anti-Coronavirus Immunoglobulin (ITAC)," 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, tolerability, 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 four hyperimmune globulin products, which includes Emergent's COVID-HIG, with a background therapy of remdesivir in all groups.
"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, SVP and therapeutics business unit head 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."
Emergent is one of four companies providing hyperimmune globulin products for the trial, which plans to enroll approximately 500 patients across U.S. and international clinical trial sites. The ITAC investigators will assess whether giving people anti-coronavirus hyperimmune globulin at the onset of COVID-19 symptoms could augment the natural—and possibly delayed—antibody response to SARS-CoV-2, thereby potentially reducing the risk of more serious illness and death. The main goal of the trial is to compare the health status of participants treated with hyperimmune globulin plus remdesivir with participants treated with a placebo plus remdesivir. Remdesivir, an investigational broad-spectrum antiviral, was developed by Gilead Sciences, Inc.
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, part of the U.S. Department of Health and Human Services' Office of the Assistant Secretary for Preparedness and Response. COVID-HIG will also be evaluated as a potential post-exposure prophylaxis (PEP) therapeutic in populations at high risk of exposure to SARS-CoV-2, such as front-line health care workers and military service members, with funding from the U.S. Department of Defense. The Investigational New Drug (IND) application to enable use of COVID-HIG in the ITAC study was submitted to the U.S. Food and Drug Administration (FDA) and subsequently cleared in August. The IND supports use of COVID-HIG in NIAID's current ITAC trial and will also support the additional treatment and PEP indications to be investigated in future clinical studies.
For more information about the ITAC trial, visit the posting on clinicaltrials.gov.