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.
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
this case, COVID-19 caused by the virus SARS-CoV-2. 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.
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
more information visit www.emergentbiosolutions.com. Find us on
LinkedIn and follow us on Twitter @emergentbiosolu and Instagram
@life_at_emergent.
Emergent’s Response to COVID-19Emergent
BioSolutions is deploying its decades of experience in vaccine and
hyperimmune development and manufacturing, as well as its
molecule-to-market contract development and manufacturing (CDMO)
services to provide comprehensive medical countermeasure solutions
in response to the COVID-19 pandemic.
Using its established hyperimmune platforms, Emergent is
developing two investigational plasma-based treatments - COVID-19
Human Immune Globulin (COVID-HIG) and COVID-Equine Immune Globulin
(COVID-EIG). COVID-HIG is being developed as a human plasma-derived
therapy candidate with $14.5 million in HHS funding and will be
evaluated in two studies, inclusive of INSIGHT-13 (ITAC), of the
National Institute of Allergy and Infectious Diseases, part of the
National Institutes of Health, for potential treatment of COVID-19
in severe hospitalized and high-risk patients. With $34.6 million
in funding from the Department of Defense’s Joint Program Executive
Office for Chemical, Biological, Radiological, and Nuclear Defense,
and in collaboration with the Mount Sinai Health System and
ImmunoTek Bio Centers, COVID-HIG will also be evaluated for
post-exposure prophylaxis in populations at high risk of COVID-19,
such as front-line health care workers and the military. COVID-EIG
is being developed as an equine plasma-derived therapy candidate
for potential treatment of severe disease in humans. Both
candidates are anticipated to be in clinical studies in 2020 and
2021. These investigational products are not approved by the U.S.
Food and Drug Administration and their safety and effectiveness
have not been established.
Emergent is deploying its CDMO capabilities, capacities, and
expertise to support the U.S. government’s Operation Warp Speed to
pave the way for innovators to advance COVID-19 programs. The
company is working with four innovators to develop and manufacture
COVID-19 vaccine candidates. For the COVID-19 vaccine response,
Emergent’s integrated CDMO network provides development services
from its Gaithersburg facility, drug substance manufacturing at its
Baltimore Bayview facility, and drug product manufacturing at its
Baltimore Camden and Rockville facilities, all in Maryland.
For 22 years Emergent has focused on advancing public health,
and its multi-pronged approach to tackling COVID-19 demonstrates
its commitment to its mission – to protect and enhance life.
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 the ability of COVID-HIG to effectively treat
hospitalized patients with COVID-19, as well as high-risk, acute
symptomatic patients and to become an effective PEP therapeutic for
groups at high risk of developing COVID-19, and the ability of
COVID-EIG to treat severe disease in humans, as well as statements
regarding planned clinical trials, 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 overall success
of the collaboration and planned development programs; our ability
to maintain a sufficient level of convalescent plasma; the results
of planned clinical trials and the timing of and our ability to
obtain and maintain regulatory authorizations for emergency or
broader patient use or approvals; 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.
Media
Contact:Miko B. NeriSenior
Director, Global Communications & Public
Affairs240-631-3392nerim@ebsi.com
Investor
Contact:Robert G. BurrowsVice
President, Investor Relations240-631-3280burrowsr@ebsi.com
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