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
GlobulinHyperimmune 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 the Mount Sinai Health
SystemThe Mount Sinai Health System is New York City's
largest academic medical system, encompassing eight hospitals, a
leading medical school, and a vast network of ambulatory practices
throughout the greater New York region. Mount Sinai is a national
and international source of unrivaled education, translational
research and discovery, and collaborative clinical leadership
ensuring that we deliver the highest quality care—from prevention
to treatment of the most serious and complex human diseases. The
Health System includes more than 7,200 physicians and features a
robust and continually expanding network of multispecialty
services, including more than 400 ambulatory practice locations
throughout the five boroughs of New York City, Westchester, and
Long Island. The Mount Sinai Hospital is ranked No. 14 on U.S.
News & World Report's "Honor Roll" of the Top 20 Best
Hospitals in the country and the Icahn School of Medicine as one of
the Top 20 Best Medical Schools in country. Mount Sinai Health
System hospitals are consistently ranked regionally by specialty
and our physicians in the top 1% of all physicians nationally
by U.S. News & World Report.
For more information,
visit https://www.mountsinai.org or find Mount Sinai
on Facebook, Twitter and YouTube.
About Emergent
BioSolutionsEmergent BioSolutions is a global life
sciences company whose mission is to protect and enhance life.
Through our specialty products and contract development and
manufacturing services, we are dedicated to providing solutions
that address public health threats. Through social responsibility,
we aim to build healthier and safer communities. We aspire to
deliver peace of mind to our patients and customers so they can
focus on what’s most important in their lives. In working together,
we envision protecting or enhancing 1 billion lives by 2030. For
additional information, visit our website and follow us on
LinkedIn, Twitter and Instagram.
Emergent BioSolutions Safe Harbor
StatementThis press release includes forward-looking
statements within the meaning of the Private Securities Litigation
Reform Act of 1995. Any statements, other than statements of
historical fact, including statements regarding whether prophylaxis
with COVID-HIG could protect individuals following high-risk
exposure to SARS-CoV-2 and significantly benefit front-line
healthcare workers and military personnel and the use of COVID-HIG
as a potential safe and effective treatment in hospitalized
patients are forward-looking statements. These forward-looking
statements are based on our current intentions, beliefs and
expectations regarding future events. We cannot guarantee that any
forward-looking statement will be accurate. Investors should
realize that if underlying assumptions prove inaccurate or unknown
risks or uncertainties materialize, actual results could differ
materially from our expectations. Investors are, therefore,
cautioned not to place undue reliance on any forward-looking
statement. Any forward-looking statement speaks only as of the date
of this press release, and, except as required by law, we do not
undertake to update any forward-looking statement to reflect new
information, events or circumstances.
There are a number of important factors that could
cause the company's actual results to differ materially from those
indicated by such forward-looking statements, including the success
of the collaboration and planned development programs; the
availability of antibody-rich plasma; the results of clinical
trials; the timing of and our ability to obtain and maintain FDA
approval or authorization for emergency or broader patient use of
COVID-HIG; and our commercialization, marketing and manufacturing
capabilities. The foregoing sets forth many, but not all, of the
factors that could cause actual results to differ from our
expectations in any forward-looking statement. Investors should
consider this cautionary statement, as well as the risk factors
identified in our periodic reports filed with the SEC, when
evaluating our forward-looking statements.
Contacts:
Emergent
BioSolutionsMedia:Miko B. NeriSenior
Director, Global Communications & Public
Affairs240-631-3392nerim@ebsi.com
Investor:Robert G. BurrowsVice
President, Investor Relations240-631-3280burrowsr@ebsi.com
Mount Sinai Health SystemElizabeth
DowlingDirector, Media
Relations347-541-0212elizabeth.dowling@mountsinai.org
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