Hyundai Bio Science announced on Friday that it has completed the registration of its first patient for the global clinical trial of a dengue treatment currently underway in Vietnam.
While the site initiation visit (SIV) marks the final preparations for the clinical institution’s operational systems and trial readiness, the registration of the first patient signifies the actual commencement of drug administration and clinical data collection from real patient groups.
This clinical trial is garnering attention due to the current situation in Vietnam. According to local authorities, the country has reported 31,927 dengue cases and four deaths this year.
This represents a 2.2-fold increase in patient numbers compared to the same period last year. The European Centre for Disease Prevention and Control (ECDC) also reported that Vietnam has recorded 27,365 dengue cases in 2023, indicating an overall doubling of cases compared to the previous year.
Medical experts view the registration of the first patient as a crucial turning point, marking the beginning of actual patient data generation.
In areas where treatments are scarce or limited, the acquisition of significant efficacy and safety data could potentially lead to increased interest in expedited regulatory reviews or conditional approvals. However, this will ultimately depend on future clinical outcomes and regulatory decisions.
Bae Byung-jun, Chief Executive Officer (CEO) of Hyundai Bio, stated that the completion of the first patient registration is a significant milestone, indicating that the global clinical trial has officially begun with real patient groups. He added that the swift progression from the site initiation visit to the first patient registration demonstrates that the clinical trial in Vietnam is proceeding smoothly and efficiently.
Bae further emphasized that while this clinical trial focuses on dengue treatment in Vietnam, its implications extend far beyond. Hyundai Bio aims to validate the potential for developing universal antiviral treatments through this trial, backed by real-world data.