Takeda have announced that the pivotal Phase 3 trial of its TAK-003, its tetravalent dengue vaccine candidate met the primary efficacy endpoint.
Dengue virus is the fastest spreading mosquito-borne viral disease and is in the WHO’s 2019 top ten threats to global health. The prevalence of individual serotypes varies across different geographies, countries, regions & seasons. Recovery from infection by one serotype provides lifelong immunity against only that serotype. Later exposure to any of the remaining serotypes is associated with an increased risk of severe and frequently fatal disease. Roughly half of the world now lives under the threat of dengue and is estimated to cause 400 million infections and 20,000 deaths annually, infecting people of all ages.
The vaccine was efficacious in preventing dengue fever caused by any of the four serotypes of the virus. The trial was Takeda’s largest ever interventional clinical trial that enrolled over 20,000 healthy children and adolescents aliving in dengue-endemic areas including Brazil, Colombia, Panama, Dominican Republic and Nicaragua, the Philippines, Thailand and Sri Lanka. Takeda’s vaccine candidate is based on a live-attenuated dengue serotype 2 virus that provides the genetic “backbone” for all four vaccine serotypes.
GreyRigge Associates is excited to have supported Takeda and previously Inviragen, since 2012 towards making a small contribution in meeting this critical milestone. We look forward to continuing to support the development of the vaccine as it moves towards the launch and enabling the prevention of this devastating disease in people around the globe.