Japanese pharma company Takeda has announced that its dengue vaccine candidate TAK-003 met its primary efficacy endpoint in a Phase III trial.
Data from the Tetravalent Immunization against Dengue Efficacy Study (TIDES) found that TAK-003 was able to prevent dengue fever caused by any four serotypes of the virus.
The drug candidate, which is a tetravalent vaccine candidate based on live-attenuated dengue serotype 2 virus, was well-tolerated during the trial and no safety concerns were reported.
TIDES is Takeda’s largest interventional trial to date. It enrolled 20,000 healthy children and adolescents aged between four and 16 living in dengue-endemic areas in Latin America and Asia.
These results confirm 18-month data from the Phase II DEN-204 trial published in November 2017 in the Lancet Infectious Diseases journal. This assessed the safety and immunogenicity of TAK-003 in 1,794 children aged between two and 17 living in the Dominican Republic, Panama and the Philippines.
President of Takeda’s global vaccine business unit Rajeev Venkayya said:
We are very encouraged by the performance of our dengue vaccine candidate in the study. This brings us one step closer to helping the world tackle the massive burden of dengue.
TIDES is ongoing and further results are expected later in 2019 and then in 2021; the trial plans to assess the long-term safety and efficacy of the drug in preventing dengue.
We are excited to publish the data in a peer-reviewed journal as quickly as possible. In parallel, we are advancing the clinical development, commercial manufacturing, and stakeholder consultations to support a potential future global launch of the vaccine.
TAK-003 is Takeda’s only Phase III vaccine candidate, however, the company is developing vaccines for other high-priority diseases. Its early stage pipeline includes candidates for Zika, polio and norovirus.
Vaccines was one of the core areas listed by Takeda CEO Christophe Weber that would help transform the company into a global player.