Emergent BioSolutions and Mount Sinai Health System began a program to evaluate Emergent’s COVID-19 Human Hyperimmune Globulin (COVID-HIG) candidate for phase one trials of its preventative capabilities among individuals at high risk of exposure.
“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,” Dr. Laura Saward, SVP and Therapeutics Business Unit Head at Emergent BioSolutions, said. “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.”
The phase one trials will consist of two parts: one will study safety and pharmacokinetics of three dose levels administered through IV doses in healthy adults, while a second will evaluate safety, pharmacokinetics, and pharmacodynamics of two dose levels administered through IV to adults with confirmed SARS-CoV-2, the virus that causes COVID-19.
The latter will target adults with either asymptomatic or mild cases of COVID-19. With front-line health care workers and military personnel being primary targets for the study, the U.S. Department of Defense (DoD) has also offered to support it with $34.6 million. This is in addition to $14.5 million awarded to Emergent by the U.S. Department of Health and Human Services (HHS) in April.
“The DOD looks forward to reviewing the results of this important clinical trial and is 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 the Chemical, Biological, Radiological and Nuclear Defense, said. “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.”
Already, Mount Sinai has worked with Emergent and ImmunoTek Bio Centers to collect plasma from recovered donors. This plasma will support the development and production of COVID-HIG for the trials.