SEOUL,
South Korea, April 18,
2024 /PRNewswire/ -- South
Korea's biotechnology company Hyundai Bioscience (CEO
Oh Sang-gi, www.hyundaibioscience.com) announced on
April 15 that it would carry out
global clinical tests aimed at treating all serotypes of Dengue
virus infection.
"The fundamental way to deal with Dengue fever is taking the
antiviral drug, which is effective on all four serotypes of the
Dengue virus, in the early stage of virus infection," CEO Oh
said.
"To win emergency use authorization (EUA), we are planning
basket clinical trials in such regions as Mid/South America and Southeast Asia."
After the COVID-19 pandemic is tamed, a mounting number of
people are diagnosed with Dengue fever, a viral infection that
spreads through mosquitoes.
The number of Dengue patients in 2024 amounts to 3.58 million in
the Americas, about three times more than 2023, while those stand
at about 8,200 in Thailand and
18,000 in Malaysia.
Dengue deaths have been 758 in Brazil this year. The death toll exceeded
1,030 in Bangladesh last year.
Against this backdrop, a host of countries in the Americas and
Asia declared a public health
emergency due to Dengue.
However, there is currently no treatment for Dengue fever, which
was first confirmed in 1953. During the past 70 years, the world
has failed to develop Dengue drugs because of the following two
reasons.
First, the drug needs to be effective on all four serotypes of
Dengue virus (DENV1, DENV2, DENV3, and DENV4). The four Dengue
serotypes are different in their genomes and may show differing
clinical symptoms after infection. Those who recover from an
infection with one Dengue serotype have immunity against that
particular one only, and they can be infected with any of the
remaining three Dengue serotypes. Worse, subsequent Dengue
infections have a higher risk to result in severe Dengue such as
Dengue hemorrhagic fever.
Second, Dengue antiviral should be administered in the early
stages to properly deal with the Dengue virus. Dengue symptoms
typically occur 4 to 10 days after infection. The Dengue virus
quickly surges to the highest level in 2 to 4 days from the symptom
onset, causing severe cellular damage along with such potential
complications as hemorrhage and thrombocytopenia. Symptoms of
Dengue fever are similar to those generated by other mosquito-borne
Zika and Chikungunya viruses. As it takes time to diagnose Dengue
infection in addition to the symptom onset, patients may suffer
from severe cellular damage even after they are treated.
Hence, a broad-spectrum antiviral drug effective on all such
mosquito-borne viruses is necessary to treat Dengue fever and
similar mosquito-borne illnesses.
Hyundai Bioscience has come up with a fundamental way to tackle
the difficulties in developing the Dengue drug.
Hyundai Bioscience has succeeded in re-purposing niclosamide,
which has been proven to have antiviral efficacy against four
serotypes of dengue virus through past in vitro studies.
Despite niclosamide's broad-spectrum antiviral activity,
researchers failed to develop niclosamide-based antivirals due to
its low absorption and short half-life. Yet, Hyundai Bioscience
tackled the challenges with bio-friendly inorganic substances and
polymers based on its proprietary drug delivery system (DDS)
technology,
Hyundai Bioscience proved through a clinical test that a
niclosamide-based drug, called Xafty®, can safely and
effectively treat COVID-19 by shortening the time required to
improve COVID-19 symptoms.
In vitro studies showed that niclosamide had antiviral effects
against not only four serotypes of Dengue fever but also Zika and
Chikungunya viruses.
Recently, Hyundai Bioscience completed the development of a
niclosamide-based formulation to treat Dengue fever with a drug
concentration level at or above 50% viral inhibition (IC50), which
can also work on Zika, Chikungunya, and Yellow fever viruses.
With the new drug, patients with Dengue fever symptoms can be
treated early without having to verify whether they are caused by
the Dengue virus or other mosquito-borne ones. Such early treatment
can also prevent the Dengue viral load from reaching the peak, thus
helping patients recover.
In the near future, Hyundai Bioscience plans to initiate
clinical studies in America and Southeast
Asia with the aim of emergency use authorization. Candidate
countries in the Americas are Puerto
Rico and Brazil while those
in Asia are Malaysia, Thailand, Singapore, and Vietnam.
As niclosamide was proven to be effective in all serotypes of
Dengue fever, and the niclosamide-based drug showed its safety
through pre-clinical and clinical studies, prompt later-stage
clinical development of the Dengue antiviral is possible to receive
emergency use authorization.
In particular, Hyundai Bioscience plans to design basket
clinical trials to test not only patients of the four Dengue virus
serotypes but also those infected with other mosquito-borne
viruses, including Zika, and Chikungunya.
"The success of our future clinical study may lead to emergency
use authorization as the world's first Dengue antiviral," Hyundai
Bioscience USA CEO Kim Kyung-il said.
"That means that the world will have the first-ever
broad-spectrum antiviral drug just like penicillin, which can deal
with various bacteria at the same time."
About Hyundai Bioscience
Hyundai Bioscience is a biotechnology company that develops
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 Joobin Jung, Global Marketing Manager
(joobin@hyundaibio.com).
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SOURCE Hyundai Bioscience