Takeda’s Dengue Vaccine Candidate TAK-003 Meets Primary Endpoint in Pivotal Phase 3 Trial

January 31, 2019 /BioValleyBIOON/ -- Japanese pharmaceutical giant Takeda recently announced that its dengue vaccine candidate, TAK-003, met the primary efficacy endpoint in its pivotal Phase III clinical trial (TIDES). Initial analysis demonstrated that TAK-003 was effective in preventing dengue fever caused by any of the four serotypes. Although the review of the extensive dataset is still ongoing, TAK-003 was well tolerated, with no significant safety concerns identified to date. The TIDES study is currently underway, and additional results, along with findings from other Phase III trials, are expected later this year.

TIDES is the largest interventional clinical study conducted by Takeda to date. This double-blind, randomized, placebo-controlled study enrolled more than 20,000 healthy children and adolescents aged 4–16 years in dengue-endemic countries across Latin America and Asia. The study aims to evaluate the efficacy of a two-dose immunization regimen of TAK-003 in protecting dengue-exposed and non-infected individuals against symptomatic dengue caused by any of the four dengue virus serotypes. The study will also assess the safety and immunogenicity of the vaccine.

TAK-003 is a live-attenuated tetravalent dengue vaccine developed based on the attenuated dengue virus serotype 2 (DENV-2), which provides protection against all four vaccine virusesHeredityStudy Framework. Data from Phase I and II studies demonstrated that TAK-003 induced neutralizing antibodies against all four dengue virus serotypes across age groups and in both seropositive and seronegative individuals, with a favorable safety and tolerability profile.

It is estimated that approximately 67 million people in Asia are infected with dengue fever annually, accounting for about 70% of the global dengue burden. In endemic countries across Asia, the direct and indirect medical expenditures caused by dengue outbreaks reach up to $6.5 billion per year.

Currently, Dengvaxia is under review in the United StatesFDApriority review, with a regulatory decision expected by May 1, 2019. If approved, Dengvaxia would become the first and only medical preventive tool for dengue fever in the U.S. market.

Dengue fever (Dengue) is an acute arboviral infectious disease caused by the dengue virus and transmitted through mosquito vectors. Clinical manifestations include high fever, headache, severe myalgia and arthralgia, rash, bleeding tendency, lymphadenopathy, leukopenia, and thrombocytopenia. Dengue fever is one of the leading causes of death among children in Southeast Asia.

Dengue fever is a mosquito-borne disease, commonly known as "breakbone fever," that threatens nearly 3 billion people worldwide and is endemic in Asia and Latin America. According to the World Health Organization (WHO), more than 100 million people are infected with dengue annually. Dengue is often misdiagnosed due to its broad spectrum of clinical manifestations, ranging from mild, non-specific symptoms to life-threatening complications. Additionally, limitations in surveillance systems contribute to the underreporting of dengue cases. Globally, 500,000 people, including children, develop dengue hemorrhagic fever (DHF) each year. Timely access to appropriate medical care is critical to reducing the risk of death from severe dengue.

The WHO has set targets to reduce dengue mortality by 50% and incidence by 25% by 2020. Currently, there are no specific therapeutic agents available for dengue hemorrhagic fever. Dengue fever is caused by four distinct serotypes of the dengue virus; infection with one serotype does not confer immunity against the others, thus individuals can be repeatedly infected by different dengue virus serotypes. (Bioon.com)

Original Source:Takeda’s Dengue Vaccine Candidate Meets Primary Endpoint in Pivotal Phase 3 Efficacy Trial