Hyundai Bio to Conduct Antiviral Drug Trials in Brazil for Dengue Fever Treatment

A general antiviral drug that can treat not only dengue fever but also all mosquito-borne viral diseases.
We decided to conduct clinical trials in Brazil, which has the largest number of patients and provides the fastest possible route.

[바이오타임즈] After several discussions with a global clinical trial organization (CRO), Hyundai Bio decided to conduct a clinical trial for the treatment of niclosamide dengue fever in Brazil, which has the highest number of dengue fever patients and deaths in the world, to make rapid clinical. tests. 22 mentioned.

Hyundai Bio revealed two reasons why they decided to conduct clinical trials for the treatment of dengue fever in Brazil.

First, Brazil is the country with the most damage in the world from dengue fever. According to Brazilian health authorities, as of April 10 this year, the number of dengue fever infections was 3,062,181, of which 1,256 people died. Brazilian health authorities expect the number of infections this year to be more than double last year’s 1.6 million cases. 71 cities in southern Brazil, including Sao Paulo and Rio de Janeiro, have declared a public health emergency.

Second, Brazil can quickly conduct clinical trials through rapid treatment for infectious diseases where there is no cure. Although the number of patients with dengue fever and deaths are increasing rapidly not only in Brazil but throughout the world, there is currently no adequate treatment. ‘Niclosamide’, the main ingredient in Hyundai Bio’s dengue fever treatment, is a drug that has been shown to have antiviral efficacy against all types of dengue fever viruses in cell tests, and tests are -clinical and clinical efficacy of niclosamide-based treatment of COVID-19. Since the safety is verified through this process, preclinical procedures can be avoided and clinical trials can be carried out immediately through the rapid review process.

Dengue fever treatment has not been developed for more than 50 years since the discovery of the dengue virus. The reason that treatment for dengue virus must meet the condition that it must be effective against all four serotypes as well as mutant viruses, but this condition is difficult to achieve.

Hyundai Bio succeeded in reintroducing niclosamide, which was found to have antiviral efficacy against four types of dengue viruses through decades of cell experiments, as a treatment for dengue fever. Hyundai Bio has overcome the problems of low niclosamide absorption and short retention time of an effective drug in the blood, which has been a challenge for 60 years, with its patented technology, the drug delivery system technology the use of inorganic materials and polymers that are harmless to him. the human body.’

Hyundai Bio recently completed the preparation of dengue fever treatment with niclosamide as the main ingredient and the drug concentration (IC50) required to inhibit 50% of the proliferation of four types of dengue viruses and mosquito-borne viruses such as Zika, chikungunya, and yellow fever. A basic solution to the treatment of dengue fever is recommended.

Hyundai Bio said that dengue fever can only be treated effectively if the treatment is given early before the rate of the virus rises rapidly. In other words, to provide early treatment, the treatment must be able to treat not only dengue fever but also other mosquito-borne viral diseases such as Zika, chikungunya, and emerging yellow fever symptoms similar to dengue fever The niclosamide dengue fever treatment preparation completed by Hyundai Bio The explanation is, because it has a universal antiviral effect that can treat not only dengue fever but all a viral disease that is carried by mosquitoes, dengue fever can be effectively treated by administering it early before the viral load rises rapidly.

The clinical trial that Hyundai Bio plans to do in Brazil is a basket-type clinical trial that differs from the existing clinical trial method. This is for patients who are infected with four types of dengue that are transmitted by mosquitoes as well as mosquito-borne viruses such as Zika, chikungunya, and yellow fever, and are found to be infected with the virus dengue after early treatment of dengue fever treatment. This is a clinical trial to confirm the effectiveness of dengue fever treatment (confirmatory clinical trial for dengue fever, investigational clinical trial for other diseases).

Meanwhile, according to the announcement of the World Health Organization (WHO) on March 28, 2024, the number of dengue fever infections in the Americas, including the United States, will be 3,578,414 cases in 2024, and the number of deaths at 1,039. This figure is three times higher than the number of disease cases reported during the same period in 2023. The global market size for dengue fever treatment is expected to reach $880 million (KRW 1.2 trillion) in 2023 and $5.4 billion (KRW 7.2 trillion) in 2033.

Kim Kyung-il, CEO of Hyundai Bioscience USA, said, “As a result of this clinical trial, we will be able to urgently obtain approval as a dengue fever treatment not only in Brazil but also in other countries throughout the world “We plan to set the price of the supply at around $100, which is less than half the price of the vaccine,” he said.

[바이오타임즈=김수진 기자] [email protected]

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