Clinical trials for the treatment of dengue fever are underway in Brazil. Hyundai Bioscience is conducting clinical trials for the treatment of dengue fever in Brazil. /Hyundai Bioscience
[더팩트ㅣ서다빈 기자] Hyundai Bioscience (hereinafter referred to as Hyundai Bio) is embarking on large-scale development of a treatment for dengue fever that has so far not been defeated. Attention is focused on the ability of Hyundai Bio, which has suffered ongoing losses, to advance into the global market by successfully conducting clinical trials for a dengue fever treatment.
Due to the effects of global warming, concerns about mosquito-borne viral diseases are growing around the world. According to the World Health Organization (WHO) announcement last month, the number of dengue fever infections in the Americas, including the United States, this year was 3,578,414, and the number of deaths was 1,039, or more than tripled the number of deaths. cases compared to the same period last year (2023).
Dengue virus, discovered in 1953, is in high demand across the world as there is no cure even after 70 years. There are two reasons why existing pharmaceutical and biologics companies have had difficulty developing treatments for dengue fever. There are four types of dengue viruses, each with different genetic characteristics and infection symptoms. First, the treatment must be effective against all four types. Second, treatment for dengue fever must be given early before the viral load increases. In order to administer timely medications, it must be able to treat other mosquito-borne viral diseases such as Zika, yellow fever and chikungunya.
Hyundai Bio plans to conduct clinical trials for the treatment of dengue fever in Brazil. Brazil is a country that can quickly conduct clinical trials on a fast track to treatments for infectious diseases for which there is no cure.
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 viruses through cellular experiments. It also has a universal antiviral effect capable of treating all mosquito-borne viral diseases. All previously mentioned challenges in the treatment of dengue fever have been overcome. Since Hyundai Bio has confirmed the safety of “Zefty”, a niclosamide-based COVID-19 treatment, through preclinical and clinical studies in the past, it is possible to skip preclinical procedures and immediately conduct integrated clinical studies for approval of the use of emergency.
Hyundai Bio plans to conduct a clinical trial different from the existing clinical trial method for emergency use approval. A basket trial is a clinical trial that first administers dengue fever treatment to patients infected with a mosquito-borne virus and then confirms the effectiveness of dengue fever treatment for patients found to be infected with the dengue virus. Hyundai Bio announced that it plans to set the future supply price of the treatment in the $100 range, less than half the price of the vaccine.
A Hyundai Bio official said: “There are many variables in clinical trials depending on clinical institutions and patient recruitment in the region, but considering that the number of dengue fever patients in Brazil is rapidly increasing and that it is currently a emergency situation, we are aiming for clinical approval this year.”
According to Brazilian health authorities, 2,966,339 people have been infected with dengue fever in Brazil this year alone, or 1.4% of the total population. This is the highest number of infections since 2000, when the Brazilian Ministry of Health began monitoring the number of dengue fever cases.
Meanwhile, Jeffty, a COVID-19 treatment drug for which Hyundai Bio has invested more than 40 billion won in research and development (R&D) costs, is not receiving emergency use approval in due to differences in the positions of the Ministry of Food and Drug Safety (MFDS) and the company. After the endemic epidemic, the competitiveness of COVID-19 treatments has significantly decreased compared to before, and Hyundai Bio desperately needs products to improve profitability.
Hyundai Bio’s sales last year were 9.5 billion won, up 22 percent from the previous year. On the other hand, last year’s operating profit was -9.8 billion won. Looking at operating profit by year, it is in the red with -4.5 billion won in 2020, -9.8 billion won in 2021, and -26.4 billion won in 2022. A Hyundai Bio official said: “Operating profit posted a deficit due to a significant increase in current development costs due to the progress of Phase 2 clinical trials for COVID-19 treatments.”
Even if Hyundai Bio’s dengue fever treatment is approved, it will take some time before it generates profits. Although it will be difficult to successfully make profits in the short term, it is expected that huge profits can be generated if the treatment is successfully developed, as there is a large unmet demand in the dengue fever treatment market.
Additionally, Hyundai Bio is preparing for Phase 1 clinical trials in Australia for its new pancreatic cancer drug, Polytaxel. Additionally, we plan to conduct clinical trials of oral cancer treatment that metabolizes niclosamide for patients with incurable cancers such as ovarian cancer and esophageal cancer caused by p53 gene mutation. If the P53 gene, which senses DNA damage in cells and induces cell death, is mutated, it becomes resistant to existing cancer drugs and cancer cells rapidly metastasize.
According to WHO, the global market size for dengue fever treatment is expected to increase from US$880 million (about 1.2 trillion won) in 2023 to US$5.4 billion (about 7.2 trillion won) in 2033.
The dengue fever virus is an endemic disease that spreads when a mosquito carrying the dengue virus bites a person. It occurs mainly in tropical and subtropical regions such as Asia, the South Pacific, Africa and the Americas. When dengue fever becomes infected, symptoms such as high fever, headache, muscle aches, joint pain and skin rashes appear. If complications such as bleeding and low blood pressure become severe, they can lead to death.
A Hyundai Bio official said: “If the integrated clinical trial is successful, we believe it will not take long to receive emergency use authorization (EUA)” and added: “We expect the clinical period to be drastically reduced compared to the normal clinical period”. period.” He added: “Based on US Food and Drug Administration (FDA) standards, if clinical trials are optimized through interim analysis results, we believe rapid progress of EUA is possible in related countries and cities where there is no treatment and there is a crisis.”
Hyundai Bioscience was spun off from Hyundai Electronics in 2000 and continued its monitor manufacturing business, but changed its name to Hyundai Bioscience in 2018 when its core business transitioned to bio.
bongouss@tf.co.kr
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