Emergent BioSolutions Inc. got the go-ahead from the European Medicines Agency (EMA) to pursue its proposed development plan for its chikungunya virus vaccine candidate.
The company has proposed conducting a Phase 3 trial using Serum Neutralizing Antibodies (SNA) to predict clinical benefit of the vaccine candidate.
“Emergent is encouraged by the concurrence we have received from EMA in paving the path for chikungunya vaccine development based on SNA as the surrogate endpoint,” Abbey Jenkins, senior vice president and vaccines business unit head at Emergent BioSolutions, said. “As a leading provider of travel health vaccines, Emergent seeks to address the threat posed by this highly debilitating virus by defining a realistic and optimal path to bring to market a much-needed chikungunya vaccine that could potentially serve patients worldwide.”
Chikungunya is a virus that is spread to people through infected mosquitoes. Symptoms include high-grade fever, joint pain, headache, muscle pain, joint swelling, or rash, while chronic arthritis occurs in a minority of patients. Outbreaks have occurred in more than 70 countries including those in North and South America, Africa, Asia, and Europe. Currently, there is no vaccine to prevent or medicine to treat chikungunya.
Emergent’s chikungunya virus virus-like particle vaccine candidate, CHIKV VLP, is currently being investigated in a Phase 2 study of approximately 430 healthy adults at three U.S. sites. In November, the company presented updated results indicating that after a single dose, up to 98 percent of study participants produced a neutralizing antibody response against the virus within seven days after vaccination. For the subjects who received a single dose, the immune response persisted for at least one year.
“We look forward to continuing to work with regulators, including the U.S. Food and Drug Administration (FDA) with whom we had our End-of-Phase 2 meeting last December, as we plan to initiate a pivotal Phase 3 trial this year and define the approach for a post-approval confirmatory efficacy trial,” Jenkins said.
The CHIKV VLP vaccine candidate is licensed from the National Institute of Allergy and Infectious Diseases at the National Institutes of Health. It received FDA Fast Track designation in May 2018 and EMA PRIME designation in September 2019, according to the company.