[메디칼업저버 신형주 기자] Hyundai Bio is conducting global clinical trials in the United States and Southeast Asia with the goal of obtaining emergency use approval for the treatment of dengue fever.
The fundamental solution for the treatment of dengue fever is the early administration of antiviral drugs effective against all four types of dengue virus infections.
After Covid-19, the dengue fever pandemic is coming. The number of patients and deaths due to dengue fever, an acute febrile disease transmitted through mosquitoes, is rapidly increasing worldwide.
The number of dengue fever patients this year is 3,578,414 in the Americas, including the United States (2,966,399 in Brazil, 191,923 in Paraguay), 8,197 in Thailand and 18,024 in Malaysia.
The number of patients in the Americas has tripled compared to the same period last year. The number of deaths due to dengue fever was 758 in Brazil this year and 1,030 in Bangladesh last year.
As a result, several countries, including Peru, Rio de Janeiro, Puerto Rico, Singapore, the Philippines, and Indonesia, have declared a “dengue fever public health crisis.”
Although the number of dengue fever patients and deaths is rapidly increasing worldwide, there is currently no adequate treatment. Dengue fever was first identified in 1953. Even though 70 years have passed since then, a cure has not yet been developed.
First, there are four types of dengue viruses (serotypes DENV1, DENV2, DENV3, and DENV4). This is because it is difficult to develop an effective treatment against all four types of dengue viruses.
These four types of dengue viruses have different genetic characteristics and symptoms after infection. If you are infected with one type of dengue virus, you develop immunity to that virus, but you do not develop immunity to other types of dengue viruses.
This can cause people who have previously been infected with one type of dengue virus to become infected with another type of dengue virus. In these cases there is a risk of experiencing more serious complications such as dengue hemorrhagic fever.
Therefore, only treatments that are effective against all four types of dengue viruses can treat dengue fever.
Dengue fever can only be effectively treated when treatment is given early, before the viral load increases rapidly. The reason is that the symptoms of dengue fever begin to appear between 4 and 10 days after infection.
Viral levels peak within two to four days of the onset of symptoms, which can cause severe cell damage and lead to more serious complications such as bleeding or thrombocytopenia.
Dengue fever, Zika, chikungunya and yellow fever have similar symptoms, so it is difficult to accurately diagnose whether the symptoms are due to dengue fever or another viral disease and takes a long time to diagnose.
If treatment is given after the diagnosis confirms that the symptoms are due to dengue fever, effective treatment cannot be performed because severe cell damage has already occurred.
In order to administer treatment early, the treatment must be able to treat not only dengue fever but also other mosquito-borne viral diseases such as Zika, chikungunya and yellow fever that show similar symptoms to dengue fever.
To simultaneously provide effective treatment against dengue fever and similar infections, it is necessary to develop a universal antiviral agent that can treat not only dengue fever but also all mosquito-borne viral diseases.
Hyundai Bio has solved the challenges of developing a treatment for dengue fever and presented a fundamental solution for the treatment of dengue fever.
Hyundai Bio has succeeded in recreating niclosamide, which has been shown to have antiviral efficacy against four types of dengue viruses through decades of cellular experiments, as a treatment for dengue fever.
Niclosamide was found to have antiviral efficacy against all four types of dengue viruses, but was unable to resolve the issues of “low absorption rate” and “short retention time of effective drug concentration in the blood” for 60 years, so it has not been conducted in human clinical trials. He could not be reached.
Hyundai Bio overcame 60 years of trouble with niclosamide with its “drug delivery technology using inorganic substances and polymers that are harmless to the human body.”
Through clinical trials of a COVID-19 treatment (Zefty) based on niclosamide as the main ingredient, Hyundai Bio has overcome the challenges of niclosamide and confirmed that it is a safe drug, also demonstrating that it is effective in improving 12 symptoms of COVID-19. 19.
Niclosamide, the main ingredient in the treatment of dengue fever, is a substance that has been confirmed through cellular experiments to have antiviral effects not only against four types of dengue viruses, which are mosquito-borne viruses, but also against the Zika and chikungunya.
Hyundai Bio recently completed a formulation for the treatment of dengue fever with niclosamide as the main ingredient and the drug concentration (IC50) required to inhibit the proliferation of four types of dengue viruses and mosquito-borne viruses such as Zika, chikungunya and yellow fever. .
If dengue fever-like symptoms appear in the early stages, treatment for dengue fever can be given early before it is confirmed which mosquito-borne viral infection is causing the symptoms, and dengue fever can be treated effectively before the virus level in the human body reaches its peak.
As the formulation for the treatment of dengue fever has been completed, Hyundai Bio will soon receive approval for emergency use for the treatment of dengue fever in one US country, including the US territory of Puerto Rico and Brazil, and in a Southeast Asian country, including Malaysia, Thailand, Singapore, and Vietnam, which have declared a public health crisis due to dengue fever. We plan to conduct global clinical trials with the goal.
Niclosamide, the main ingredient in the treatment of dengue fever, is a drug that has been shown to have antiviral efficacy against all types of dengue viruses in cellular experiments, and the safety of niclosamide-based COVID-19 treatment (Zefty) has been confirmed through preclinical and clinical studies, therefore, it is possible to skip the preclinical procedures and immediately conduct integrated clinical studies for emergency use approval.
Hyundai Bio announced that it plans to conduct clinical trials for emergency use approval in a basket clinical trial different from the existing clinical trial method.
The clinical trial to be conducted by Hyundai Bio involves the early administration of dengue fever treatment to patients infected not only with the four types of dengue transmitted through mosquitoes, but also with mosquito-borne viruses such as Zika, chikungunya and yellow fever. clinical trial (confirmatory clinical trial for dengue fever, exploratory clinical trial for other diseases) to confirm the effectiveness of dengue virus treatment on patients found to be infected with .
Kim Kyung-il, CEO of Hyundai Bioscience USA, said: “If this clinical trial is successful, we will be able to receive approval for emergency use in countries around the world as a treatment for four types of dengue fever for which there is currently no treatment.” He added: “It is a single drug, like penicillin for bacteria.” This means that the world’s first universal antiviral drug has been created that cures various viral diseases, “he said.
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