- "Aiming to offer a Dengue antiviral treatment course in
$100 price range"
- Hyundai Bioscience decides to conduct dengue clinical trials in
Brazil, which has the largest
number of Dengue patients and offers a fast-track approval
SEOUL,
South Korea, April 25,
2024 /PRNewswire/ -- Hyundai Bioscience announced on
April 25th that, after
multiple consultations with global clinical research organizations
(CRO), it has decided to conduct clinical trials for its
'niclosamide-based Dengue antiviral' in Brazil, which has the highest number of dengue
cases and deaths in the world.
Hyundai Bioscience outlined two main reasons for choosing
Brazil as its Dengue clinical
trial regions:
Firstly, Brazil has been the
most affected country by the Dengue virus. According to the
Brazilian health authorities, as of April
10th this year, there has been 3,062,181 reported
cases of Dengue infections with 1,256 deaths. Brazilian health
authorities expect the number of infections this year to more than
double last year's 1.6 million cases. 71 cities in Southern Brazil, including São Paulo and Rio de Janeiro, have declared a public
health emergency over Dengue.
Secondly, Brazil offers a
fast-track process for drugs targeting diseases with no available
treatments. Although the number of Dengue cases and deaths is
rapidly increasing not only in Brazil but globally, there is no antiviral
treatment available. Niclosamide, the active pharmaceutical
ingredient of Hyundai Bioscience's Dengue antiviral, has been known
to have antiviral efficacy against all serotypes of Dengue viruses
through previous in vitro studies, and its safety has also been
confirmed through Hyundai Bioscience's preclinical and clinical
studies for COVID-19. This may enable to skip preclinical study and
to proceed promptly to clinical study through the fast-track
approval process.
Dengue treatment has not been developed for over 50 years since
the Dengue virus was discovered. Development of Dengue treatments
is challenging because it must be effective against all four
serotypes of the Dengue virus as well as against their mutants.
Hyundai Bioscience has successfully repurposed Niclosamide for
Dengue antiviral through its patented drug delivery system
technology using inorganics and polymers that are harmless to the
human body. With its proprietary technology, Hyundai Bioscience has
overcome the challenges of low bioavailability and short half-life
of Niclosamide which has pan-serotype antiviral efficacy against
Dengue according to the past in vitro studies.
Hyundai Bioscience completed the development of a
Niclosamide-based formulation for Dengue treatment, which enables
drug concentration at 50% viral inhibition level (IC 50) or higher
to inhibit the proliferation of four serotypes of the Dengue virus
as well as Zika, Chikungunya, and Yellow fever viruses. Hyundai
Bioscience stated that Dengue can be treated effectively if the
antiviral is administered early stage of the infection before the
viral load rapidly increases. Early treatment may be possible if
the drug can treat not only Dengue but also other mosquito-borne
viral infections such as Zika and Chikungunya that show similar
symptoms to Dengue. The new Niclosamide-based Dengue antiviral
formulated by Hyundai Bioscience has a broad-spectrum antiviral
efficacy that can treat not only Dengue infection but other
mosquito-borne viral infections; hence, early and effective Dengue
treatment may be possible with effective early administration
before a rapid viral load increase.
Hyundai Bioscience plans to conduct a basket-type clinical trial
in Brazil (confirmatory clinical
study for Dengue and exploratory clinical study for other
mosquito-borne viral infections). This involves administering the
antiviral early to patients infected by any of the four serotypes
of the Dengue virus as well as those infected by other
mosquito-borne viruses such as Zika and Chikungunya, and then
evaluating the drug's efficacy in the Dengue-confirmed patient
population.
According to the World Health Organization (WHO)'s announcement
on March 28, 2024, the number of
Dengue cases in the Americas reached 3,578,414 in 2024, with 1,039
deaths. This figure is 3 times the number of Dengue cases reported
at the same time in 2023. The global market for Dengue treatments
is expected to grow from $880 million
in 2023 to $5.4 billion by 2033.
"The success of Dengue clinical study on our Niclosamide-based
antiviral could lead to its emergency use authorization not only in
Brazil but also in other
countries. We plan to set the supply price in the $100 range", said Dr. Kim Kyung-Il, CEO of
Hyundai Bioscience USA.
About Hyundai Bioscience
Hyundai Bioscience is a biotechnology company that develops new
drugs based on its novel drug delivery system technologies to
deliver active ingredients safely and efficiently to targeted areas
of the human body. Founded in 2000, Hyundai Bioscience focuses on
repurposing or expanding indications of existing drugs using its
proprietary organic-inorganic hybrid technologies. Hyundai
Bioscience is a public company listed on KOSDAQ (symbol: 048410) in
South Korea.
For more information, please contact Ms. Joobin Jung, Global PR Manager
(joobin@hyundaibio.com).
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SOURCE Hyundai Bioscience