Emergent BioSolutions Announces Positive Two-Year Persistence Data From Phase 2 Study Evaluating CHIKV VLP, the Company’s C...
May 26 2021 - 6:30AM
Emergent BioSolutions Inc. (NYSE:EBS) announced two-year
persistence data from its Phase 2 clinical study evaluating the
safety and immunogenicity of the company’s investigational
chikungunya virus virus-like particle (CHIKV VLP) vaccine candidate
in 415 healthy adults. Emergent’s CHIKV VLP vaccine, the only
single-dose VLP-based vaccine currently in clinical development for
active immunization against chikungunya disease, continued to
demonstrate a favorable safety profile and had generated a
dose-related increase in neutralizing antibody response against the
chikungunya virus as previously reported. Two years
post-vaccination, SNA responses were 19 times higher than
pre-vaccination titers following a single adjuvanted 40 µg dose of
the CHIKV VLP vaccine, supporting the persistence of the immune
response. All subjects in the single-dose regimen remained
seropositive at their one-year and two-year visits. The vaccine
candidate was well-tolerated and no significant vaccine-related
safety concerns were identified. The majority of solicited adverse
events were mild or moderate in severity and the most frequent was
local injection site pain.
“Emergent is pleased with the positive data from our Phase 2
CHIKV VLP study that demonstrated safety and immunogenicity two
years post-vaccination with a single adjuvanted 40 µg dose of the
CHIKV VLP vaccine, which we believe is an ideal candidate to
evaluate in a Phase 3 study that we intend to initiate this year,”
said Karen L. Smith, M.D., Ph.D., executive vice president and
chief medical officer at Emergent BioSolutions. “Chikungunya
disease is a recognized public health threat for which no vaccine
or treatment exists. As a leader in travel health and as a company
that has tackled infectious diseases for decades as part of our
mission – to protect and enhance life – Emergent is committed to
meeting this significant unmet medical need.”
The data were presented at the International Society of Travel
Medicine (ISTM) annual meeting held May 19 to 22, 2021. The company
intends to publish the results of this study in the near-term.
The CHIKV VLP vaccine candidate received FDA Fast Track
designation in May 2018 and EMA PRIME designation in September
2019.
About the Chikungunya virusChikungunya virus is
spread to people by infected mosquitoes. Symptoms include fever,
joint pain, headache, muscle pain, joint swelling or rash. The
geographic distribution of CHIKV has expanded to more than 100
countries and territories worldwide.
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
our website and follow us on LinkedIn, Twitter,
and Instagram.
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 our ability to fill the need for an approved vaccine to
prevent the chikungunya virus, the effectiveness of the product
candidate, executing on our development program and the initiation
of a pivotal trial this year, 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
planned development program; the timing of and ability to obtain
and maintain regulatory approvals for the product candidate; 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.
Investor Contact:Robert G.
BurrowsVice President, Investor
Relations240-631-3280BurrowsR@ebsi.com
Media Contact:Matt
HartwigDirector, Media RelationsHartwigM@ebsi.com
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