Benzinga | Oct 15, 2021 06:31AM EDT

Emergent BioSolutions Reports Initiation Of Pivotal Phase 3 Trial Evaluating Safety, Immunogenicity Of Its Chikungunya Vaccine Candidate, CHIKV VLP

Emergent BioSolutions Inc. (NYSE:EBS) today announced the first participant dosed in its pivotal phase 3 study evaluating the safety and immunogenicity of the company's investigational chikungunya virus (CHIKV) virus-like particle (VLP) vaccine candidate, CHIKV VLP, in a single dose. CHIKV VLP is the only VLP-based vaccine currently in clinical development for active immunization against chikungunya disease.

"Emergent has achieved a major milestone as we begin our phase 3 study for our single-dose chikungunya vaccine candidate," said Karen L. Smith, M.D., Ph.D., executive vice president and chief medical officer at Emergent BioSolutions. "I am proud of the Emergent team for bringing us a step closer to potentially having a critical solution to address this important disease for which no vaccine or treatment is currently available. A true demonstration of our commitment to our mission -- to protect and enhance life."

The goal of this multi-center, randomized, double blind, placebo-controlled study is to evaluate the safety and immunogenicity of the CHIKV VLP vaccine candidate in healthy individuals aged 12 to 64 as well as to demonstrate the consistency of the chikungunya virus (CHIKV) serum neutralizing antibody (SNA) response across three manufactured vaccine candidate lots. The study will observe the CHIKV SNA response at day 22 as measured by geometric mean titer and seroresponse rate and will enroll at least 3,150 participants in up to 49 U.S. sites.

The structure of the CHIKV VLP is nearly identical to the wild-type virus but does not pose a risk of replication. Studies have shown that in general, other VLP vaccines are highly immunogenic, safe, and typically elicit high titer neutralizing antibodies, which are needed to protect against chikungunya virus.i,ii There is currently no licensed vaccine, VLP or otherwise, to prevent chikungunya virus disease.

Emergent's CHIKV VLP vaccine candidate received Breakthrough Therapy designation and Fast Track designation from the U.S. Food and Drug Administration in October 2020 and May 2018, respectively, and PRIME designation from the European Medicines Agency in September 2019. These designations are designed to facilitate the development or expedite review of medicines that either target an unmet medical need or may demonstrate substantial improvement over available therapy.