A general purpose antiviral drug that can treat not only dengue fever but also all mosquito-borne viral diseases.
It decided to conduct clinical trials in Brazil, which has the largest number of patients and offers the fastest possible route.
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[바이오타임즈] After several discussions with a global clinical trial agency (CRO), Hyundai Bio decided to conduct a clinical trial for the treatment of dengue fever with niclosamide in Brazil, which has the highest number of dengue fever patients and deaths in world, in order to conduct a rapid clinical trial 22 trials announced.
Hyundai Bio has revealed two reasons why it decided to conduct clinical trials for the treatment of dengue fever in Brazil.
First of all, Brazil is the country with the greatest damage caused by dengue fever in the world. 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 treatments for infectious diseases for which there is no cure. Although the number of dengue fever patients and deaths is rapidly increasing not only in Brazil but around 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 cellular experiments, and preclinical and clinical studies on the treatments are underway COVID-19 based niclosamide Since safety has been confirmed through this process, preclinical procedures can be skipped and clinical trials can be conducted immediately through the expedited review process.
Treatment for dengue fever has not been developed in the more than 50 years since the dengue virus was discovered. The reason is that a treatment for dengue virus must meet the condition of being effective against all four serotypes and against mutant viruses, but it is difficult to meet this condition.
Hyundai Bio has succeeded in reinventing 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. Hyundai Bio has overcome the problems of niclosamide’s low absorption rate and short retention time of the effective concentration of the drug in the blood, which have been a challenge for 60 years, with its patented technology, a drug delivery system using substances inorganic and harmless polymers for the human body.’
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 50% of the proliferation of four types of dengue viruses and mosquito-borne viruses such as Zika, chikungunya and yellow fever A fundamental solution has been proposed for the treatment of dengue fever.
Hyundai Bio said dengue fever can only be treated effectively if treatment is administered early, before the level of the virus increases rapidly. In other words, in order to administer a 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 treatment formulation of dengue fever completed by Hyundai Bio The explanation is that, since it has a universal antiviral effect that can treat not only dengue fever but all mosquito-borne viral diseases, dengue fever can be effectively treated by administering it early before the viral load increase rapidly.
The clinical trial that Hyundai Bio intends to conduct in Brazil is a basket-type clinical trial, which is different from the existing clinical trial method. This is for patients who are infected with four types of mosquito-borne dengue and mosquito-borne viruses such as Zika, chikungunya and yellow fever and who are found to be infected with dengue virus after early administration of dengue fever treatment. This is a clinical study to confirm the effectiveness of the treatment of dengue fever (confirmatory clinical study for dengue fever, exploratory clinical study for other diseases).
Meanwhile, according to the World Health Organization (WHO) announcement 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 will be 1.039. . This figure is three times higher than the scale of infection cases reported in the same period in 2023. The global market size for dengue fever treatments is expected to reach US$880 million (KRW 1.2 trillion) in 2023 and US$5.4 billion (KRW7.2 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 treatment for dengue fever not only in Brazil but also in other countries around the world . “We plan to set the supply price at around $100, which is less than half the price of the vaccine,” he said.
[바이오타임즈=김수진 기자] sjkimcap@biotimes.co.kr
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