The Danish company’s vaccine candidate met all co-primary endpoints in a late-stage study in adults and adolescents just months after publishing trial data for elderly patients, as it seeks to challenge Valneva.
Pictured: Syringe drawing up vaccine/iStock, Diy13
The competitive race to develop an effective chikungunya vaccine is heating up, after Danish biotech Bavarian Nordic posted positive Phase III results for its vaccine candidate—the second late-stage trial data in as many months.
The latest results from Bavarian Nordic’s study of over 3,500 patients found that its virus-like particle (VLP)-based candidate produced strong induction of chikungunya-inducing antibodies in 98% of those who had received the vaccine versus placebo. In addition, 97% of subjects had antibodies induced within two weeks of vaccination “confirming a rapid onset of protective levels of immunity,” the company said in a statement.
Bavarian Nordic also noted that the vaccine was “well-tolerated in this adolescent and adult population and adverse events were mainly mild or moderate in nature.”
The positive results follow good news from Bavarian Nordic in June, when the company posted similar Phase III study results for an older population. While those results were not as strong, they nevertheless showed chikungunya-neutralizing antibodies in 87% of participants within three weeks of vaccination after a single vaccination, which were also “well-tolerated,” Nordic said.
The race to develop an effective chikungunya vaccine has been heating up. French biotech Valneva reported promising Phase III results around the same time Nordic was posting its results in elderly patients. The Valneva study, published in The Lancet, found its vaccine had a 28-day seroprotection rate of 98.9%. In patients aged 18-64, the seroprotection rate was 98.6% and patients aged 65 or older had a 100% seroprotection rate. The study also noted that more than half of patients given the vaccine experienced an adverse event, with two serious adverse events were deemed to be related to it.
Valneva’s vaccine was submitted to the FDA’s rolling submissions, which the regulator gave Priority Review, with a decision expected this month. Bavarian Nordic, for its part, will be using the results from its two latest studies to support applications to both the FDA and the European Medicines Agency.
“With a fast and durable response, our vaccine has the potential to be the best in class to prevent chikungunya infections in adolescents to elderly adults,” Bavarian Nordic CEO Paul Chaplin said in a statement, noting that the company’s “focus remains to finalize the studies and prepare for regulatory submissions next year.”
However, the field is less crowded after Merck dropped out of the vaccine race in February, as reported by Fierce Biotech. The decision was made as part “routine pipeline prioritization,” according to a company spokesperson.
While serious symptoms and death are rare, chikungunya is a widespread disease present in over 110 countries and there is currently no vaccine, according to the World Health Organization. However, the disease has high morbidity and, consequently, a heavy economic and healthcare burden. Caused by a Togaviridae virus carried by Aedes Aegypti mosquitos, chikungunya causes symptomatic infection in up to 92% of infected humans.
Connor Lynch is a freelance writer based in Ottawa, Canada. Reach him at lynchjourno@gmail.com.
