[Yu Jin-hee, Edaily Reporter] Hyundai Bioscience announced on April 23 that it has commenced global clinical trials for CP-COV03, an oral antiviral drug. The randomized, double-blind, placebo-controlled Phase 2/3 trials will initially target dengue fever and related infectious diseases. The trials are expected to serve as a stepping stone toward developing a universal antiviral therapy capable of addressing future pandemics.
 | | Photo provided by Hyundai Bioscience. |
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The trials will be conducted in two phases. The initial phase will involve 210 confirmed dengue patients to assess CP-COV03’s safety and efficacy. Patients will be divided into one placebo group (30 patients) and three experimental groups receiving varying doses (60 patients per group). Researchers will evaluate the drug’s ability to reduce viral load, improve symptoms, and analyze pharmacokinetic correlations to identify an optimal dosage for Phase 3 trials.
Following dose determination, the subsequent trial will expand to include patients with dengue and similar viral infections, such as Zika, influenza A, and COVID-19. Patients will receive treatment at the onset of symptoms, with a later classification of their specific disease. This “basket trial” approach reflects the healthcare realities in equatorial regions lacking adequate diagnostic infrastructure, aiming to initiate treatment earlier.
Dengue fever, prevalent primarily in tropical and subtropical regions, is transmitted by mosquitoes such as Aedes aegypti and Aedes albopictus. According to recent WHO statistics, dengue infections surpassed 14 million in 2024, with actual infections estimated around 400 million annually. No specific antiviral treatment exists currently, leaving symptomatic relief and fluid management as the primary interventions.
Oral antivirals offer a more feasible solution than vaccines for low- and middle-income countries due to lower costs and simplified logistics. If effective against multiple viral diseases with similar pathogenesis, a single drug like CP-COV03 could become a vital first-line response during outbreaks of emerging infectious diseases.
Hyundai Bioscience anticipates that these trials will position CP-COV03 as a robust global antiviral therapy. The company aims to establish international partnerships to provide practical therapeutic options in countries vulnerable to infectious diseases and build a global treatment platform to address cross-border public health threats.
“These clinical trials go beyond simply treating dengue; they explore the potential of CP-COV03 as a universal antiviral effective against similar infections like Zika, chikungunya, and yellow fever,” said Bae Byung-joon, CEO of Hyundai Bioscience. “Leveraging the safety and efficacy proven in previous COVID-19 trials, we aim to introduce a new global paradigm for infectious disease treatment.”
