Emergent BioSolutions Inc. said on Tuesday it began the first phase of a clinical study for its anti-Zika virus immune globulin, known as ZIKV-IG, which was fast-tracked by the U.S. Food and Drug Administration (FDA) in 2017.
Concern over Zika virus disease, transmitted by mosquitoes, has risen since Brazil in 2015 reported an association between the Zika virus and microcephaly and other congenital abnormalities in developing fetuses and newborns, according to the World Health Organization. A total of 86 countries and territories have reported Zika infections.
“Zika is an important disease with global impact due to its profound effect on the fetus and child-maternal health,” said Dr. Laura Saward, senior vice president and antibody therapeutics business unit head at Emergent BioSolutions. “Our program, initiated in 2017, seeks to accelerate development of a Zika-specific immune globulin that leverages our proven platform technology, four decades of patient experience with hyperimmunes, and core competencies in advanced development and manufacturing.”
ZIKV-IG is a purified human immunoglobulin that hosts neutralizing antibodies for the targeted virus. For the Phase 1 study, ZIKV-IG will be put through a double-blind, randomized, placebo-controlled study involving around 30 volunteers, according to Emergent BioSolutions, a Gaithersburg, Maryland-based global life sciences company.
By granting ZIKV-IG fast track designation, the FDA is helping to bring important new treatments to patients quicker, through speedier development and hastened reviews. The World Health Organization has also stated the need for accelerated research and development for ways to counter the Zika virus given its potential to cause a public health emergency in the absence of effective vaccines for the disease, Saward said.