Hyundai BioScience is set to launch its global clinical trials for a broad-spectrum antiviral treatment, starting with a Site Initiation Visit (SIV) in Vietnam for a drug targeting dengue fever and related illnesses.
Industry insiders report that the clinical trial kick-off meeting is scheduled for March 30 at a local research facility in Vietnam.
This crucial gathering will finalize trial protocols, operational procedures, investigator training, role assignments, and regulatory compliance measures, setting the stage for an immediate commencement of the clinical trials.
Following a preliminary event on March 5 attended by key Vietnamese health officials, Hyundai BioScience has been working closely with the clinical institution to expedite the process, confirming March 30 as the official start date for the trials.
Dengue fever, a major infectious disease that regularly causes widespread outbreaks in tropical and subtropical regions, including Southeast Asia, remains classified as an untreatable condition due to the lack of approved therapies.
This Vietnamese trial represents a significant milestone in global clinical research, as it aims to validate the potential of a broad-spectrum antiviral treatment in an area with a pressing medical need.
The trial’s first phase will administer XAFTY, a niclosamide-based broad-spectrum antiviral drug utilizing Hyundai BioScience’s proprietary drug delivery technology, to adult patients with dengue virus infection. Using a randomized, double-blind, placebo-controlled design, researchers will evaluate the drug’s safety and efficacy in reducing viral load. The second phase will expand to a basket trial, exploring the drug’s potential against Zika, COVID-19, and influenza.
Vietnam’s National Institute of Tropical Medicine, a leading 1,000-bed facility under the Ministry of Health, has been at the forefront of treating and researching major infectious diseases like dengue.
This trial goes beyond mere collaboration, involving institutions with extensive experience in infectious disease treatment and clinical research, ensuring that the drug’s efficacy is rigorously tested in real-world public health settings.
Baek Byung-jun, Chief Executive Officer (CEO) of Hyundai BioScience, emphasized the significance of this milestone: Initiating these clinical trials in Vietnam marks a pivotal shift from conceptual research to practical global clinical operations for our broad-spectrum antiviral treatment. He added that following the March 30 kick-off meeting in Vietnam, it aims to begin patient enrollment and initial dosing in early April. The goal is to accelerate the clinical process and complete the trials within the year.
Baek further stressed the company’s commitment to demonstrating the viability of their platform strategy, starting with the currently untreatable dengue fever and expanding to similar infectious diseases. He also highlighted their collaborative efforts to establish Vietnam as a hub for infectious disease treatments in Southeast Asia.