Commemorative photo of the signing ceremony for the clinical agreement between representatives of the National Hospital for Tropical Diseases of Vietnam and Hyundai Bio. / Photo by Hyundai Bio
Hyundai Bio has signed a clinical agreement (MOU) on the 27th after receiving approval from the Vietnamese health authorities to conduct simultaneous basket clinical trials targeting mosquito-borne viral infections such as dengue fever, Zika, and chikungunya, as well as various viral infections of different families and species including COVID-19 and influenza A virus infections, using its developed broad-spectrum antiviral agent, Jepti, in collaboration with the National Hospital of Tropical Diseases (NHTD) in Vietnam.
This basket clinical trial is explained as the world's first clinical trial that verifies the therapeutic effects of one treatment on multiple viral infections simultaneously, rather than the conventional antiviral drug trials that verify the therapeutic effect of one drug on one infection.
At the 'American Society for Microbiology Annual Meeting' held in Houston, Texas, USA, last June, Hyundai Bio presented the clinical trial results of the COVID-19 treatment Jepti, proposing to the global medical community that "treating multiple viral infections with one drug is the only way to treat viral infections currently lacking treatments and to prepare for future viral infection pandemics," thereby suggesting a paradigm shift in antiviral drug development. Since then, Hyundai Bio has accelerated the development of the broad-spectrum antiviral agent Jepti.
Hyundai Bio confirmed through cell experiments that Jepti has antiviral efficacy against 33 species of viruses across 16 families including COVID-19, AIDS, dengue fever, and Ebola. However, it focused on niclosamide, which has limitations such as poor absorption in the body and a short duration of maintaining effective blood concentration. Using patented drug delivery technology, Hyundai Bio overcame these two challenges of niclosamide for the first time in the world and re-created Jepti as an oral antiviral agent with niclosamide as the main ingredient.
Through clinical trials on humans, animal experiments, and cell experiments, Hyundai Bio has confirmed that "Jepti, containing niclosamide as the main ingredient, is effective against viral infections in animals and humans for viruses shown to be effective with niclosamide in cell experiments." Hyundai Bio conducted clinical trials of Jepti for COVID-19, demonstrating its safety and efficacy. The results of this clinical trial are significant as they were the first to reveal that "if niclosamide is effective in cell experiments, it can also treat the corresponding viral disease in humans." Jepti is currently undergoing Phase 3 clinical trials for COVID-19 targeting high-risk patients.
Hyundai Bio subsequently conducted animal experiments to verify the efficacy of Jepti against H1N1, a subtype of influenza A virus expected to cause future pandemics. The results confirmed Jepti's excellent effect in reducing influenza virus levels. This experimental result was the first to reveal that Jepti, confirmed effective against COVID-19, also has efficacy against respiratory viruses of different families in vivo.
On August 6th, at the 'Disease Prevention and Control Summit 2024' held in Philadelphia, USA, Hyundai Bio announced that "only broad-spectrum antivirals (One drug-multiple targets) that treat multiple viral infections with one drug can address viral diseases currently lacking treatments and prepare for future viral disease pandemics such as avian influenza. Currently, Jepti is the only broad-spectrum antiviral."
Meanwhile, Hyundai Bio has planned to conduct a 'Jepti Long COVID investigator-initiated clinical trial' this month in collaboration with Dr. David Smith's research team at the University of California San Diego (UCSD).
A representative from the National Hospital of Tropical Diseases in Vietnam expressed hope that "this clinical trial will open the way to treat many tropical disease patients suffering from the lack of treatments." Additionally, a Vietnamese health authority official stated, "The Jepti clinical trial could be a new breakthrough in treating various viral diseases including dengue fever. We will actively cooperate in this clinical trial to establish Vietnam as a hub for viral disease treatment development."
Hyundai Bio CEO Sang-gi Oh stated, "This basket clinical trial will mark the beginning of the era of broad-spectrum antivirals that simultaneously treat multiple viral infections such as dengue fever with one treatment."
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