Hyundai Bioscience to conduct phase 3 clinical trial for high-risk group of COVID-19 patients with the goal of emergency use authorization

• "Xafty® can be the only oral COVID-19 treatment that can be prescribed to high-risk group patients who cannot take Paxlovid®"
• "While maintaining the current process for emergency use authorization for mild-to-moderate COVID-19 patients, Hyundai Bioscience will expedite Phase 3 clinical trial exclusively for high-risk group"

SEOUL, South Korea, Aug. 28, 2024 /PRNewswire/ -- Hyundai Bioscience Co., Ltd, currently pursuing Emergency Use Authorization (EUA) for its oral COVID-19 treatment, Xafty®, for mild-to-moderate cases, announced on August 27th that it has submitted an Investigational New Drug (IND) application for 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 those aged 60 and above, adults over 19 with underlying conditions such as diabetes, hypertension, cardiovascular 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 higher priority group for global health authorities.

As COVID-19 cases surge again recently, the number of confirmed cases and hospitalizations is rapidly increasing. Among hospitalized patients, over 65% are aged 65 or older. Despite the rising number of high-risk group patients and hospitalizations, there are currently 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 contraindicated medications and thus limiting their effectiveness. There is an urgent need for a treatment that can be safely prescribed to high-risk group without such concerns.

In response, the U.S. National Institutes of Health (NIH) conducted a global Phase 3 clinical trial of a Japanese COVID-19 treatment aimed at high-risk group patients who cannot take Paxlovid®, but the trial failed to meet its primary endpoints. This situation makes Xafty® the only remaining possible option. Hyundai Bioscience promptly began preparations for a Phase 3 study targeting the high-risk group following the NIH's announcement of the Japanese treatment's clinical results.

Xafty® has already demonstrated its efficacy and safety in a previous clinical trial involving 300 mild-to-moderate COVID-19 patients, where it demonstrated rapid improvement in all 12 symptoms. In particular, a separate statistical analysis requested by the Korea Disease Control and Prevention Agency (KDCA) on high-risk group patients revealed that Xafty® was even more effective for 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 move forward with an additional Phase 3 clinical study focused on high-risk COVID-19 patients. The number of participants will be significantly increased 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 that required hospitalization of all participants, this trial will involve outpatient visits only, allowing faster recruitment and significant cost savings—estimated at 20% to 25% less per patient compared to the previous study.

Dr. Geun-Woo Jin, Executive Vice President of Hyundai Bioscience, stated, "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. 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."

Mr. Oh Sang-gi, the CEO of Hyundai Bioscience, added, "We are pursuing a dual-track strategy for Xafty®'s emergency use authorization. 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."

About Hyundai Bioscience

Hyundai Bioscience is a biotechnology company that develops new drugs based on its novel drug delivery system technologies to deliver active ingredients safely and efficiently to targeted areas of the human body. Founded in 2000, Hyundai Bioscience focuses on repurposing or expanding indications of existing drugs using its proprietary organic-inorganic hybrid technologies. Hyundai Bioscience is a public company listed on KOSDAQ (symbol: 048410) in South Korea.

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SOURCE Hyundai Bioscience