Hyundai Bioscience is advancing its oral COVID-19 treatment, Xafty, into a Phase 3 clinical trial specifically designed for high-risk patients. The company submitted an Investigational New Drug (IND) application to the Ministry of Food and Drug Safety (MFDS) of the Republic of Korea, marking a significant step towards providing a treatment option for a vulnerable population with limited alternatives.
The trial will focus on individuals aged 60 and above, as well as adults over 19 with underlying conditions such as diabetes, hypertension, cardiovascular disease, chronic heart and lung diseases, or those who are immunocompromised. These patients face a higher risk of severe complications from COVID-19, making the development of safe and effective treatments a critical priority.
Unmet Needs in High-Risk COVID-19 Treatment
Despite the availability of treatments like Paxlovid, many high-risk patients are unable to use them due to potential drug interactions with their existing medications. A recent global Phase 3 clinical trial by the U.S. National Institutes of Health (NIH) of a Japanese COVID-19 treatment aimed at high-risk patients who cannot take Paxlovid failed to meet its primary endpoints, further highlighting the urgent need for alternative options. According to Hyundai Bioscience, this positions Xafty as a potentially crucial solution for this patient group.
Promising Efficacy Data
Xafty has already shown positive results in a previous clinical trial involving 300 patients with mild-to-moderate COVID-19, demonstrating rapid improvement across 12 symptoms. A separate statistical analysis, requested by the Korea Disease Control and Prevention Agency (KDCA), indicated that Xafty was particularly effective in high-risk patients already taking medications for conditions like diabetes, hypertension, and heart disease.
Phase 3 Trial Design
The upcoming Phase 3 trial will significantly increase the participant pool from the previous 120 to 290, dividing them into test and control groups of 145 each. Unlike earlier trials that required hospitalization, this study will be conducted on an outpatient basis, streamlining recruitment and reducing costs by an estimated 20% to 25% per patient.
"While Paxlovid is available for high-risk patients, those who are taking contraindicated medications cannot be prescribed Paxlovid, leaving them in a treatment blind spot," said Dr. Geun-Woo Jin, Executive Vice President of Hyundai Bioscience. "The Japanese COVID-19 treatment, developed under the NIH’s lead for high-risk patients, failed to clear the Phase 3 hurdle. As a result, Xafty now stands as the only viable solution for this urgent global need for high-risk patients."
Dual-Track Strategy for Emergency Use Authorization
Hyundai Bioscience is pursuing a dual-track strategy for Xafty's emergency use authorization (EUA). "While continuing the current EUA process for the general COVID-19 patient treatment, we will also promptly conduct an additional Phase 3 trial exclusively for high-risk group patients to ensure they have access to a safe and effective treatment," stated Mr. Oh Sang-gi, CEO of Hyundai Bioscience.
