Emergent BioSolutions (NYSE: EBS) and Mount Sinai Health System today announced initiation of the clinical program to evaluate Emergent's COVID-19 Human Hyperimmune Globulin (COVID-HIG) product candidate in the first of two Phase 1 studies to support its use for potential post-exposure prophylaxis in individuals at high risk of exposure to SARS-CoV-2, the virus that causes COVID-19, such as front-line health care workers and military personnel.
The first study will evaluate safety and pharmacokinetics of three dose levels administered as a single or repeat IV dose in healthy adults. The second study, once initiated, will evaluate safety, pharmacokinetics, and pharmacodynamics of two dose levels administered as a single IV dose to adults with SARS-CoV-2 infection, whether asymptomatic or with mild COVID-19.
"Emergent is pleased to partner with Mount Sinai, a leader in clinical research to combat COVID-19, and expand the clinical evaluation of COVID-HIG," said Dr. Laura Saward, SVP and Therapeutics Business Unit Head at Emergent BioSolutions. "This innovative public-private partnership represented by government, industry, and healthcare providers has the potential to make a significant impact benefiting our front-line health care workers and others who protect us."
"Mount Sinai is thrilled to be initiating research into potentially important therapeutics against COVID-19," said Judith A. Aberg, MD, Chief of the Division of Infectious Disease at Mount Sinai Health System. "Our team has developed a great scientific partnership with Emergent and looks forward to performing this important research."
The existing plasma collection capabilities at Mount Sinai established through its collaboration with Emergent and ImmunoTek Bio Centers has enabled ongoing plasma collection from recovered donors to support the development and manufacture of COVID-HIG for evaluation in clinical trials. The clinical research program, including a planned Phase 2 study, is designed to assess whether prophylaxis with COVID-HIG could help protect individuals following high-risk exposure to SARS-CoV-2.
The U.S. Department of Defense's (DOD) Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense (JPEO-CBRND) has provided $34.6 million in funding in support of this program.
"The DOD looks forward to reviewing the results of this important clinical trial and is pleased to support this initiative, which should enhance the nation's rapid response to COVID-19," said Douglas Bryce, the DOD's Joint Program Executive Officer for CBRND. "Working together through public-private partnerships harnesses expertise from government, industry, and academia, increasing our chances of developing safe and effective medical countermeasures for this, and other biological threats."
Advancing COVID-HIG With U.S. Government Support
In addition to receiving DOD funding to advance a post-exposure prophylaxis indication for COVID-HIG, Emergent was awarded $14.5 million in April 2020 by the U.S. Department of Health and Human Services (HHS) to develop COVID-HIG as a potential treatment for COVID-19. Emergent's proprietary COVID-HIG product candidate is also being evaluated in a Phase 3 clinical study initiated in October 2020 by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), as a potential treatment in hospitalized patients. Mount Sinai serves as a study site.
About Hyperimmune Globulin
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 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 hyperimmune globulin manufactured from plasma of individuals with elevated levels of antibodies to SARS-CoV-2. COVID-HIG is not approved by the U.S. Food and Drug Administration and its safety and effectiveness have not been established.
About Emergent BioSolutions
