Takeda initiated development in 2016, following the BARDA contract.

Japanese pharmaceutical company Takeda has announced that its purified, inactivated, alum-adjuvanted, whole Zika virus vaccine candidate (TAK-426) progressed into a Phase I clinical trial. The milestone, said Takeda, was reached only 15 months after it received the contract from the Department of Health and Human Services; Office of the Assistant Secretary for Preparedness and Response; Biomedical Advanced Research and Development Authority (BARDA) to develop a safe, effective Zika virus vaccine.

The clinical study will be managed as a randomized, placebo-controlled, double-blind trial and is intended to determine the safety and immunogenicity of the vaccine candidate among 240 adult female and male patients between the ages of 18 and 49. The trial will take place in the continental U.S.

Rajeev Venkayya, President of Takeda’s Global Vaccine Business Unit stated on the development: “We are pleased to reach this important milestone, which reflects our commitment to addressing the Zika threat, as well as the significant capabilities of Takeda’s global organization. This progress,” he explained, “could not have been possible without the ongoing support of, and collaboration with, BARDA.”

Takeda notes that over the past few years the Zika virus has had a real impact, spreading across 84 countries, a disease characterized by WHO as a Public Health Emergency of International Concern (PHEIC). The Centers for Disease Control and Prevention (CDC) also elevated its response efforts to its highest level (Level 1) and even though WHO has since declared an end to the PHEIC, Zika remains a serious global health issue.

According to Takeda, the public health threat posed by the virus led them to mobilize a multifunctional team immediately upon signing the BARDA contract. The prioritization, said Takeda, allowed the company to respond quickly and bring its most promising candidate to trial within 15 months. Initial data from ZIK-101 is expected in 2018. With the Phase I data to support it, work toward initiating Phase II studies are expected to begin as soon as possible.