Emergent BioSolutions Announces Publication of CHIKV VLP Phase 2 Safety and Immunogenicity Data in The Lancet Infectious Diseases
Emergent BioSolutions (NYSE:EBS) announced the publication of two-year persistence data from its Phase 2 trial of a chikungunya virus vaccine in The Lancet Infectious Diseases. The study involved 415 participants and demonstrated that a single 40 μg dose of the aluminum hydroxide-adjuvanted CHIKV VLP vaccine candidate was well-tolerated, inducing a robust immune response lasting up to two years. The company is moving forward with Phase 3 trials, emphasizing the vaccine's potential to address a public health threat with no existing vaccine or treatment.
- Publication of Phase 2 trial results highlights vaccine's effectiveness and safety.
- Vaccine candidate induced durable immune response lasting two years.
- Emergent is progressing to Phase 3 clinical trials.
- None.
GAITHERSBURG, Md., June 21, 2022 (GLOBE NEWSWIRE) -- Emergent BioSolutions Inc. (NYSE:EBS) announced today that 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 were published in The Lancet Infectious Diseases. The article, Safety and immunogenicity of PXVX0317, an aluminum hydroxide-adjuvanted chikungunya virus-like particle vaccine: a randomised, double-blind, parallel-group, phase 2 trial, is available online.
“Emergent is pleased that results from our CHIKV VLP phase 2 study have been published and shared with the scientific community in The Lancet Infectious Diseases, a highly esteemed peer-reviewed journal,” said Chris Cabell, M.D., chief medical officer and SVP clinical development at Emergent BioSolutions. “Publication of this body of work highlights the importance of developing ways to address Chikungunya disease, a public health threat for which no vaccine or treatment exists.”
Summary of published results
This randomized, double-blind, parallel-group, phase 2 study was conducted at three U.S. sites with 415 participants. Eligible participants were healthy CHIKV-naïve adults aged 18–45 years. The primary endpoint was the geometric mean titer of anti-CHIKV neutralizing antibody on day 57 (28 days after the last vaccination). Safety was also assessed.
Emergent’s CHIKV VLP vaccine candidate was well tolerated and induced a robust and durable serum neutralizing antibody immune response against the Chikungunya virus up to two years. A single dose, 40 μg injection of adjuvanted CHIKV VLP is being further investigated in phase 3 clinical trials (clinicaltrials.gov identifiers NCT05072080 and NCT05349617).
A Comment, which provides expert opinion on a published article, was subsequently published by the journal, and noted that the “adjuvanted CHIKV VLP vaccine candidate is a welcome step forward.” i
About the Chikungunya virus
Chikungunya 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 BioSolutions
At Emergent, our mission is to protect and enhance life. For over 20 years, we’ve been at work defending people from things we hope will never happen—so we are prepared, just in case they ever do. We provide solutions for complex and urgent public health threats through a portfolio of vaccines and therapeutics that we develop and manufacture for governments and consumers. We also offer a range of integrated contract development and manufacturing services for pharmaceutical and biotechnology customers. To learn more about how we plan to protect or enhance 1 billion lives by 2030, visit our website and follow us on LinkedIn, Twitter, and Instagram.
Safe Harbor Statement
This 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 chikungunya disease, the effectiveness of the product candidate, and executing on our development program, 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.
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i Stephenson K, Novel chikungunya vaccine shows promise for durable protection, Lancet Infect Dis. 2022; (published online June 13)
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