Hyundai Bioscience announced that its antiviral drug candidate Xafty produced negative results in a Good Laboratory Practice (GLP)-compliant micronucleus test conducted by a certified nonclinical testing institution, addressing concerns over potential genotoxicity.
The company said the findings will support ongoing discussions with U.S. regulators regarding entry into its planned Phase 2 AIR-V basket trial for respiratory viral infections.
Earlier this year, Hyundai Bioscience presented its pandemic preparedness strategy centered on Xafty at the 2026 Biotech Showcase in San Francisco under the theme, “Addressing current viral infectious diseases is the path to preparing for future pandemics.”
The micronucleus study was conducted in accordance with guidelines established by South Korea’s Ministry of Food and Drug Safety and the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH).
The Safety Evaluation Center of DT&CRO, a certified nonclinical testing organization, assessed the occurrence of micronuclei—small chromosomal fragments formed as a result of chromosomal abnormalities following administration of the test compound.
Results showed that all dosage groups, including the maximum tolerated dose (MTD) of 1,000 milligrams per kilogram per day, demonstrated no statistically significant increase in the frequency of micronucleated polychromatic erythrocytes compared with the negative control group.
According to Hyundai Bioscience, the findings add to the safety package previously established through a 13-week repeat-dose toxicity study, which identified a no-observed-adverse-effect level (NOAEL).
The company plans to use the new nonclinical safety data, together with clinical findings from a dengue fever study conducted in Vietnam, in discussions regarding the timing of its U.S. clinical program.
Xafty is designed to target host cells rather than the virus itself. While this host-targeted approach may offer efficacy regardless of viral mutations, it has also raised concerns about potential effects on healthy cells, making genotoxicity assessment a key development hurdle.
The AIR-V study is a basket-trial design intended to evaluate a single therapeutic candidate across multiple respiratory viral infections, including COVID-19, influenza and respiratory syncytial virus (RSV).
“The results provide critical safety evidence supporting our planned entry into a U.S. Phase 2 respiratory virus trial,” said Jin Geun-woo, chief executive officer of Hyundai Bioscience. “The study confirmed the safety of a mechanism that selectively blocks viral replication pathways while preserving the chromosomal integrity of host cells.”