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“Xafty® may be the only oral COVID-19 treatment that can be prescribed to patients in the high-risk group who cannot take Paxlovid®”
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“While maintaining the current process of emergency use authorization for COVID-19 patients with mild to moderate symptoms, Hyundai Bioscience will accelerate Phase 3 clinical trials specifically for the high-risk group”
Seoul, South Korea, August 28, 2024 /PRNewswire/ — Hyundai Bioscience Co., Ltd., which is currently seeking Emergency Use Authorization (EUA) for its oral COVID-19 treatment, Xafty®, for mild to moderate cases, announced on 2018-05-22. 27 August It has submitted an Investigational New Drug (IND) application for a Phase 3 clinical trial to the Ministry of Food and Drug Safety (MFDS) of the Republic of Korea. This new trial will specifically target high-risk group patients with mild to moderate COVID-19.
The high-risk group includes people aged 60 years and above, adults aged 19 years and above with underlying illnesses such as diabetes, hypertension, heart disease, chronic heart and lung diseases, or immunocompromised individuals. These patients are at a higher risk of developing severe complications if infected with COVID-19, making them a high-priority group for global health authorities.
With the recent resurgence of COVID-19 cases, the number of confirmed cases and hospitalizations is increasing rapidly. More than 65% of hospitalized patients are aged 65 or older. Despite the increasing number of patients in the high-risk group and hospitalizations, there are limited treatment options worldwide that can be safely prescribed to this high-risk group. Existing COVID-19 treatments are known to have drug interactions, making them unsuitable for patients already taking restricted medications and thus limiting their effectiveness. There is an urgent need for treatments that can be safely prescribed to the high-risk group without any concerns.
In response, the U.S. National Institutes of Health (NIH) conducted a global Phase 3 clinical trial of a Japanese COVID-19 treatment for patients in the high-risk group who cannot take Paxlovid®, but the trial failed to meet its primary endpoints. This situation makes Xafty® the only potential alternative. Hyundai Bioscience immediately began preparations for a Phase 3 study targeting the high-risk group after the NIH announced the clinical results of the Japanese treatment.
Xafty® has already demonstrated its efficacy and safety in a previous clinical trial involving 300 mild to moderate COVID-19 patients, where it showed rapid improvement in all 12 symptoms. Notably, a separate statistical analysis requested by the Korea Disease Control and Prevention Agency (KDCA) on high-risk group patients showed that Xafty® was even more effective for the high-risk group who were on other medications for conditions such as diabetes, hypertension and heart disease.
Based on these promising results, Hyundai Bioscience has decided to proceed with an additional Phase 3 clinical study focused on high-risk COVID-19 patients. The number of participants will increase significantly from the previous 120 (40 each in the low dose, high dose and control groups) to 290 participants (145 each in the test and control groups). Unlike previous trials, which required all participants to be hospitalized, this trial will involve only outpatient visits, leading to faster recruitment and significant cost savings – estimated to be 20% to 25% lower per patient compared to the previous study.
Dr. Geun-woo JinExecutive Vice President of Hyundai Bioscience said, “While Paxlovid® is available for high-risk patients, those taking contraindicated medications cannot be prescribed Paxlovid®, leaving them without treatment. The NIH-led Japanese COVID-19 treatment developed 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 of high-risk patients.”
Mr. Oh Sang-gi, CEO of Hyundai Bioscience, said, “We are pursuing a dual-track strategy for the emergency use authorization of Xafty®. While continuing the current EUA process for general COVID-19 patient treatment, we will also immediately conduct an additional Phase 3 trial specifically for patients in the high-risk group to ensure they have access to safe and effective treatment.”
About Hyundai Bioscience
Hyundai Bioscience is a biotechnology company that develops new medicines based on its novel drug delivery system technologies to safely and efficiently deliver active ingredients to targeted areas of the human body. Founded in 2000, Hyundai Bioscience focuses on repurposing or expanding the indications of existing medicines using its proprietary organic-inorganic hybrid technologies. Hyundai Bioscience is a public company listed on KOSDAQ (Symbol: 048410) South Korea,
For further information please contact Ms. Zubin JungGlobal PR Manager ([email protected]).
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SOURCE Hyundai Bioscience