[Edaily Reporter Yoo Jin-hee] #Hyundai BioScience’s U.S. subsidiary, Hyundai Bio USA, has unveiled an unprecedented initiative to save patients in African countries affected by the Ebola outbreak: it will provide clinical trial doses of “XAFTY” (CP-COV03), a broad-spectrum antiviral candidate, free of charge and will even cover clinical trial costs directly if necessary.

Hyundai Bio announced on the 11th that Hyundai Bio USA has decided to submit an official letter containing these details to the World Health Organization (WHO) and health authorities in countries affected by the Ebola outbreak.

This sudden decision was initiated by a proposal from Dr. Davey Smith, a world-renowned infectious disease expert and professor at the University of California, San Diego, who led the NIH-led global clinical trials for COVID-19 and mpox.

Professor Smith conveyed his expert assessment to Hyundai Bio USA that the rapid deployment of JEFTY is necessary to curb the spread of the highly lethal Ebola virus, and the company’s immediate acceptance of this proposal set the international cooperation framework in motion.

Professor Smith’s proposal for the emergency deployment of Jefty is based on the WHO’s Medicines for Use in Emergencies (MEURI) guidelines. According to these regulations, in emergency situations involving fatal infectious diseases where no alternative treatments exist, preemptive administration to patients is permitted even before formal approval, provided that a minimum level of scientific data and safety is established.

Zefti has already successfully completed a Phase 2 clinical trial involving 300 participants in South Korea, securing robust safety data in humans. Hyundai Bio USA plans to immediately supply the currently stockpiled clinical trial supply of Zefti free of charge to the front lines of the pandemic response if requested by local authorities.

In addition to emergency administration, Hyundai Bio USA has also offered to cover the full cost of clinical trials should local health authorities request rapid trials to verify efficacy. This decision was made with the understanding that, in public health crises, government agencies often miss the critical window of opportunity due to budget constraints and complex procedures when conducting clinical trials.

In particular, Jefty is eligible for the “Drug History” benefit under the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) guidelines. Drugs whose safety has been proven through large-scale human clinical trials can bypass time-consuming animal efficacy tests during public health crises and proceed directly to local clinical trials. Professor Smith also cited this point as grounds for believing that an immediate clinical trial application for Jefty is feasible.

The scientific rationale is also clear. Cell culture test results confirmed that the IC50 (the drug concentration required to inhibit 50% of viral activity) of Jefty’s active ingredient against the Ebola virus is lower than that of COVID-19 or dengue virus, both of which have already demonstrated efficacy in human clinical trials. In other words, this means that even a small amount can more effectively inhibit the Ebola virus.

The company’s headquarters in Korea has also pledged active support and full backing for this humanitarian decision by the U.S. subsidiary.

Bae Byung-jun, President of Hyundai BioScience, emphasized, “With the dengue fever clinical trial currently underway in Vietnam proceeding smoothly, Jefti is poised to become a meaningful therapeutic candidate for high-risk infectious diseases such as Ebola,” adding, “The IC50 data for Ebola, confirmed at a lower concentration compared to COVID-19, provides a strong scientific rationale for moving forward with development.”

He added, “We hope that the WHO and health authorities in various countries will scientifically review the therapeutic benefits and make a swift and transparent decision.”

Kim Taek-sung, CEO of Hyundai Bio USA, also explained the rationale behind this decision, stating, “When variants emerge and countless lives are lost, the very purpose of a broad-spectrum antiviral drug is to save lives through rapid administration.” He added, “We decided to provide the drug free of charge and conduct clinical trials at our own expense to save even one more life.”

Meanwhile, Hyundai Bio USA, a member of the Medical Defense Cooperation Center (MCDC) under the U.S. Department of Defense, reported that it is storing the ZEFT clinical trial drug intended for Ebola-affected countries in accordance with regulations and has completed all preparations to supply it promptly as international procedures proceed.