Emergent BioSolutions Announces Positive Two-Year Persistence Data From Phase 2 Study Evaluating CHIKV VLP, the Company’s Chikungunya Virus Virus-Like Particle Vaccine Candidate

Rhea-AI Summary

Emergent BioSolutions reported promising two-year data from its Phase 2 clinical trial for the chikungunya virus VLP vaccine, demonstrating a significant immune response. The study involved 415 healthy adults, showing that the SNA mean titers were 19 times higher than pre-vaccination levels after a single 40 µg dose. The vaccine was well-tolerated, with mostly mild side effects. All participants remained seropositive at one and two years post-vaccination. This data supports moving to a Phase 3 trial aimed at addressing the unmet need for chikungunya vaccination.

Positive

• SNA mean titers increased by 19 times two years post-vaccination.
• Vaccine well-tolerated with mild or moderate adverse effects.
• All subjects remained seropositive at one and two years.
• Plans to initiate a Phase 3 study following positive Phase 2 results.

Negative

• None.

• A dose-related increase in immune response, as measured by anti-chikungunya virus serum neutralizing antibodies (SNA), was previously observed.
  
  
• Two years post-vaccination, SNA mean titers were 19 times higher than pre-vaccination titers following a single adjuvanted 40 µg dose reflecting persistence of the immune response.
  
  
• The vaccine candidate was well-tolerated. The majority of solicited adverse events were mild or moderate in severity.
  

GAITHERSBURG, Md., May 26, 2021 (GLOBE NEWSWIRE) -- 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 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
Emergent 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 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 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. Burrows
Vice President, Investor Relations
240-631-3280
BurrowsR@ebsi.com

Media Contact:
Matt Hartwig
Director, Media Relations
HartwigM@ebsi.com

FAQ

What were the results of Emergent BioSolutions' Phase 2 study for the EBS vaccine?

The Phase 2 study demonstrated a 19-fold increase in immune response two years post-vaccination, with the vaccine being well-tolerated.

When does Emergent BioSolutions plan to initiate the Phase 3 trial for the EBS vaccine?

Emergent BioSolutions intends to initiate the Phase 3 trial within the current year.

What is the significance of the SNA mean titers in the EBS vaccine study?

The SNA mean titers being 19 times higher than pre-vaccination levels indicate a strong and persistent immune response.

How many participants were involved in the Phase 2 trial for the EBS vaccine?

The Phase 2 clinical trial included 415 healthy adults.

What safety profile did the EBS vaccine candidate demonstrate in the trial?

The vaccine candidate exhibited a favorable safety profile, with most adverse effects being mild or moderate.