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- Takeda’s dengue vaccine candidate (TAK-003)
prevented 83.6% of hospitalizations and 62.0% of dengue illness overall, with
no identified important safety risks through three years following vaccination
in ongoing pivotal Phase 3 TIDES trial - Regulatory filings for TAK-003 progressing in
European Union and in many dengue-endemic countries; filing in United States
planned for later this year - Dengue is the fastest-spreading mosquito-borne
viral disease with an estimated 390 million cases and 500,000 hospitalizations
per year globally, with limited options for prevention
OSAKA,
JAPAN, AND CAMBRIDGE, MASSACHUSETTS – Media
OutReach – 25 May 2021 – Takeda Pharmaceutical Company Limited (TSE:4502/NYSE:TAK) (“Takeda”) today announced that its dengue vaccine candidate (TAK-003)
demonstrated continued protection against dengue illness and hospitalization,
regardless of an individual’s previous dengue exposure, with no important
safety risks identified through three years after vaccination in the ongoing
pivotal Phase 3 Tetravalent Immunization against Dengue Efficacy Study (TIDES) trial. TIDES enrolled more than 20,000 healthy
children and adolescents ages four to 16 years in dengue-endemic countries in
Latin America and Asia.
“Dengue
epidemics occur suddenly, and hospitals can become overwhelmed with severe
disease cases and people seeking testing,” said LakKumar Fernandoi,
M.D., Center for Clinical Management of Dengue and Dengue Haemorrhagic Fever,
Negombo General Hospital, Sri Lanka and a primary investigator of the TIDES
trial. “Results from the long-term analysis of Takeda’s dengue vaccine
candidate suggest that it could help with outbreak prevention, reduce rates of
hospitalization and protect people from dengue regardless of their previous
exposure. Importantly, no important safety risks were identified.”
Safety
and efficacy results from the 36-month follow-up exploratory analysis of TIDES
were presented on May 22, 2021, at the 17th Conference of the International
Society of Travel Medicine (CISTM). Through three years (36 months after the
second dose), TAK-003 demonstrated overall vaccine efficacy (VE) of 62.0% (95%
CI: 56.6% to 66.7%) against virologically-confirmed dengue (VCD), with 65.0% VE
(95% CI: 58.9% to 70.1%) in seropositive individuals and 54.3% VE (95% CI:
41.9% to 64.1%) in seronegative individuals. TAK-003 also demonstrated 83.6% VE
(95% CI: 76.8% to 88.4%) against hospitalized dengue, with 86.0% VE (95% CI:
78.4% to 91.0%) in seropositive individuals and 77.1% VE (95% CI: 58.6% to
87.3%) in seronegative individuals. Observations of varied VE by serotype
remained consistent with previously reported results. No evidence of disease
enhancement was observed. TAK-003 was generally well tolerated, and there were
no important safety risks observed. The results reinforce the potential of
TAK-003 to help protect those who are living in or traveling to dengue-endemic
countries.
“Our
dengue vaccine candidate continued to provide protection against dengue
throughout three years, and was especially robust in preventing
hospitalization,” said Derek Wallace, VP, Dengue Global Program Leader at
Takeda. “These results reinforce my confidence that TAK-003 can help
address the significant global burden of dengue.”
As
previously reported, the TIDES trial met its primary endpoint of overall VE against VCD at 12-months follow-up (VE: 80.2%; 95% CI:
73.3% to 85.3%; p<0.001) and all secondary endpoints for which there were a sufficient number of dengue cases (measured at
18-months follow-up). The TIDES trial has been amended to include the
evaluation of a booster dose to address the waning of overall VE observed over
time (from 12 through 36 months after the second dose), largely driven by
outpatient dengue. Takeda intends to publish results of the 36-month
exploratory analysis in a peer-reviewed journal this year.
TIDES
safety and efficacy data through 36-months follow-up was included in regulatory
submissions to the European Union and dengue-endemic countries and will be part
of additional filings planned for 2021, including in the United States. Takeda
will seek an indication for TAK-003 for the prevention of dengue disease in
individuals four to 60 years of age, regardless of previous virus exposure,
based on data in both adults and children. There remains a need for dengue
vaccines that can be used in both dengue-naïve and dengue-exposed adults and
children.
About TAK-003
Takeda’s
tetravalent dengue vaccine candidate (TAK-003) is based on a live-attenuated
dengue serotype 2 virus, which provides the genetic “backbone” for all four
vaccine viruses.1 Clinical Phase 2 data in children and
adolescents showed that TAK-003 induced immune responses against all four dengue serotypes, in both seropositive
and seronegative participants, which persisted through 48 months after vaccination,
and the vaccine was found to be generally safe and well tolerated.2
The pivotal Phase 3 Tetravalent Immunization against Dengue Efficacy Study
(TIDES) trial met its primary endpoint of overall vaccine efficacy (VE) against virologically-confirmed dengue (VCD) at
12-months follow-up and all secondary endpoints at 18-months follow-up for which there were a sufficient number of dengue
cases, including VE against hospitalized dengue and VE in baseline seropositive
and baseline seronegative individuals.3,4 Efficacy varied by
serotype. The results demonstrated TAK-003 was generally well tolerated, and
there have been no important safety risks observed to date.
About the Phase 3 TIDES (DEN-301) Trial
The
double-blind, randomized, placebo-controlled Phase 3 Tetravalent Immunization
against Dengue Efficacy Study (TIDES) trial is evaluating the safety and
efficacy of two doses of TAK-003 in the prevention of laboratory-confirmed
symptomatic dengue fever of any severity and due to any of the four dengue
virus serotypes in children and adolescents.4 The TIDES trial is
Takeda’s largest interventional clinical trial to date and enrolled over 20,000
healthy children and adolescents ages four to 16 years living in dengue-endemic
areas. Study participants were randomly assigned to receive either TAK-003 0.5
mL or placebo by subcutaneous injection on Day 1 and Day 90.4 The
study is comprised of five parts. Part 1 and the primary endpoint analysis
evaluated vaccine efficacy (VE) and safety through 12 months after the second
dose.4 Part 2 continued for an additional six months to complete the
assessment of the secondary endpoints of VE by serotype, baseline serostatus
and disease severity, including VE against hospitalized dengue.4
Part 3 is evaluating VE and long-term safety by following participants for an
additional two and a half to three years.5 Part 4 will evaluate
efficacy and safety for 13 months following booster vaccination and Part 5 will
evaluate long-term efficacy and safety for one year after completion of Part 4.5
The
trial is taking place at sites in dengue-endemic areas in Latin America
(Brazil, Colombia, Panama, the Dominican Republic and Nicaragua) and Asia
(Philippines, Thailand and Sri Lanka) where there are unmet needs in dengue
prevention and where severe dengue is a leading cause of serious illness and
death among children.4 Baseline blood samples were collected from
all individuals participating in the trial to allow for evaluation of safety
and efficacy based on serostatus. Takeda and an independent Data Monitoring
Committee of experts are actively monitoring safety on an ongoing basis.
About Dengue
Dengue
is the fastest spreading mosquito-borne viral disease and was one of the WHO’s
top 10 threats to global health in 2019.6,7 Dengue is mainly spread
by Aedes aegypti mosquitoes and, to a lesser extent, Aedes albopictus mosquitoes.
It is caused by any of four dengue virus serotypes, each of which can cause
dengue fever or severe dengue. The prevalence of individual serotypes varies
across different geographies, countries, regions, seasons and over time.8
Recovery from infection by one serotype provides lifelong immunity against only
that serotype, and later exposure to any of the remaining serotypes is
associated with an increased risk of severe disease.
Dengue
is pandemic prone, and outbreaks are observed in tropical and sub-tropical
areas and have recently caused outbreaks in parts of the continental United
States and Europe.9,10 Approximately half of the world now lives
under the threat of dengue, which is estimated to cause 390 million infections
and around 20,000 deaths globally each year.10,11 The dengue virus
can infect people of all ages and is a leading cause of serious illness among
children in some countries in Latin America and Asia.10
Takeda’s Commitment to Vaccines
Vaccines
prevent 2 to 3 million deaths each year and have transformed global public
health.12 For the past 70 years, Takeda has supplied vaccines to
protect the health of people in Japan. Today, Takeda’s global vaccine business
is applying innovation to tackle some of the world’s most challenging infectious
diseases, such as dengue, COVID-19, Zika and norovirus. Takeda’s team brings an
outstanding track record and a wealth of knowledge in vaccine development,
manufacturing and global access to advance a pipeline of vaccines to address
some of the world’s most pressing public health needs. For more information,
visit https://www.takedavaccines.com/.
Important Notice
For the purposes of this notice, “press
release” means this document, any oral presentation, any question and answer
session and any written or oral material discussed or distributed by Takeda
Pharmaceutical Company Limited (“Takeda”) regarding this release. This press
release (including any oral briefing and any question-and-answer in connection
with it) is not intended to, and does not constitute, represent or form part of
any offer, invitation or solicitation of any offer to purchase, otherwise
acquire, subscribe for, exchange, sell or otherwise dispose of, any securities
or the solicitation of any vote or approval in any jurisdiction. No shares or
other securities are being offered to the public by means of this press
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violation of applicable securities laws.
The companies in which Takeda directly
and indirectly owns investments are separate entities. In this press release,
“Takeda” is sometimes used for convenience where references are made to Takeda
and its subsidiaries in general. Likewise, the words “we”, “us” and “our” are
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These expressions are also used where no useful purpose is served by
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position and results of operations, including estimates, forecasts, targets and
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“anticipates”, “estimates”, “projects” or similar expressions or the negative
thereof. These forward-looking statements are based on assumptions about many
important factors, including the following, which could cause actual results to
differ materially from those expressed or implied by the forward-looking
statements: the economic circumstances surrounding Takeda’s global business,
including general economic conditions in Japan and the United States;
competitive pressures and developments; changes to applicable laws and
regulations, including global health care reforms; challenges inherent in new
product development, including uncertainty of clinical success and decisions of
regulatory authorities and the timing thereof; uncertainty of commercial success
for new and existing products; manufacturing difficulties or delays;
fluctuations in interest and currency exchange rates; claims or concerns
regarding the safety or efficacy of marketed products or product candidates;
the impact of health crises, like the novel coronavirus pandemic, on Takeda and
its customers and suppliers, including foreign governments in countries in
which Takeda operates, or on other facets of its business; the timing and
impact of post-merger integration efforts with acquired companies; the ability
to divest assets that are not core to Takeda’s operations and the timing of any
such divestment(s); and other factors identified in Takeda’s most recent Annual
Report on Form 20-F and Takeda’s other reports filed with the U.S. Securities and
Exchange Commission, available on Takeda’s website at: https://www.takeda.com/investors/reports/sec-filings/ or at www.sec.gov. Takeda does not undertake to update any of the forward-looking
statements contained in this press release or any other forward-looking
statements it may make, except as required by law or stock exchange rule. Past
performance is not an indicator of future results and the results or statements
of Takeda in this press release may not be indicative of, and are not an
estimate, forecast, guarantee or projection of Takeda’s future results.
Medical information
This press release contains information
about products that may not be available in all countries, or may be available
under different trademarks, for different indications, in different dosages, or
in different strengths. Nothing contained herein should be considered a
solicitation, promotion or advertisement for any prescription drugs including
the ones under development.
References
i Dr.
LakKumar Fernando did not receive compensation for his statement.
1 Huang CY-H,
et al. Genetic and phenotypic characterization of manufacturing seeds for
tetravalent dengue vaccine (DENVax). PLoS Negl Trop Dis. 2013;7:e2243.
2 Tricou, V,
Sáez-Llorens X, et al. Safety and immunogenicity of a tetravalent dengue vaccine in children
aged 2-17 years: a randomised, placebo-controlled, phase 2 trial. Lancet. 2020. doi:10.1016/S0140-6736(20)30556-0.
3 Biswal S,
et al. Efficacy of a tetravalent dengue vaccine in healthy children and
adolescents. N Engl J Med. 2019;2019;381:2009-2019.
4 Biswal S, et
al. Efficacy of a tetravalent dengue vaccine in healthy children aged 4-16
years: a randomized, placebo controlled, phase 3 trial. Lancet. 2020.
2020;395:1423-1433.
5
ClinicalTrials.Gov. Efficacy, Safety and Immunogenicity of Takeda’s Tetravalent Dengue
Vaccine (TDV) in Healthy Children (TIDES). Retrieved
March 2021.
6 World
Health Organization. Factsheet. Dengue and Severe Dengue. April
2019. Retrieved February 2021.
7 World
Health Organization. Ten threats to global health in 2019. 2019.
Retrieved February 2021.
8 Guzman MG,
et al. Dengue: a continuing global threat. Nature
Reviews Microbiology. 2010;8:S7-S16.
9 Knowlton K,
et al. Mosquito-Borne Dengue Fever Threat Spreading in the Americas. The Natural Resources Defense Council (NRDC). 2009. Retrieved February
2021.
10 Chan E, et
al. Using web search query data to monitor dengue epidemics: a new model for
neglected tropical disease surveillance. PLoS Negl Trop Dis. 2011;5:e1206.
11 Centers for
Disease Control and Prevention. About
Dengue: What You Need to Know. May 2019.
Retrieved February 2021.
12 UNICEF. Vaccination and Immunization Statistics. 2019.
Retrieved February 2021.
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