Emergent BioSolutions Initiates Phase 3 Clinical Study to Evaluate AV7909 for Post-Exposure Prophylaxis of Anthrax
March 19 2019 - 6:30AM
Emergent BioSolutions Inc. (NYSE:EBS) today announced the
initiation of a Phase 3 trial to evaluate the lot consistency,
immunogenicity, and safety of AV7909 (anthrax vaccine adsorbed with
CPG 7909 adjuvant) following a two-dose schedule administered
intramuscularly in healthy adults. AV7909 is being developed for
post-exposure prophylaxis of disease resulting from suspected or
confirmed Bacillus anthracis exposure.
“Emergent is pleased with the advancement of the AV7909
development program,” said Abbey Jenkins, senior vice president and
vaccines and anti-infectives business unit head at Emergent
BioSolutions. “Dosing the first subject in this large clinical
study is a milestone achievement and we look forward to continuing
to execute on our development and procurement contract for
AV7909.”
AV7909 is designed to elicit a faster immune response than the
currently available anthrax vaccine. It is comprised of Anthrax
Vaccine Adsorbed (AVA) in combination with an adjuvant, the
immunostimulatory oligodeoxynucleotide compound CPG 7909. The
addition of CPG 7909 to AVA has been shown, in previous Phase 1 and
Phase 2 studies, to safely accelerate and enhance the immune
response.
In evaluating the lot consistency of AV7909, the study will be
using three consecutively manufactured lots of the vaccine
candidate. This Phase 3 randomized, double-blind, parallel-group
study plans to enroll 3,850 adults across 35 sites within the U.S.
with an overall study duration of approximately 20 months. More
information on the study is available on
https://clinicaltrials.gov/ct2/show/NCT03877926.
Contract HHSO100201600030C for the advanced development and
delivery of AV7909 is funded by the Biomedical Advanced Research
and Development Authority, a division within the Office of the
Assistant Secretary for Preparedness and Response in the U.S.
Department of Health and Human Services.
About Emergent BioSolutionsEmergent
BioSolutions Inc. is a global life sciences company seeking to
protect and enhance life by focusing on providing specialty
products for civilian and military populations that address
accidental, intentional, and naturally occurring public health
threats. We aspire to be a Fortune 500 company recognized for
protecting and enhancing life, driving innovation, and living our
values. Additional information about the company may be found at
www.emergentbiosolutions.com. Find us on LinkedIn and follow us on
Twitter @emergentbiosolu and Instagram @life_at_emergent.
Safe Harbor StatementThis press release
includes forward-looking statements within the meaning of the
Private Securities Litigation Reform Act of 1995, including
statements regarding the potential immune response to AV7909. Any
statements, other than statements of historical fact, 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 ultimate success
of the planned development program; our ability to secure EUA
pre-authorization approval of AV7909 from the FDA within the
anticipated timeframe, if at all; our ability to manufacture the
product candidate at desired quantities within the anticipated
timeframe; and the results of clinical trials and our
commercialization and marketing 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.
Investor Contact:Robert G.
BurrowsVice President, Investor
Relations240-631-3280BurrowsR@ebsi.com
Media Contact:Lynn KiefferVice
President, Corporate
Communications240-631-3391KiefferL@ebsi.com
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