Hyundai Bioscience to begin phase 3 trial for high-risk COVID-19 patients aiming for emergency use approval

Hyundai Bioscience Co., Ltd, based in Seoul, South Korea, recently announced a significant development in its efforts to combat COVID-19. The company has submitted an Investigational New Drug (IND) application for a Phase 3 clinical trial to the Ministry of Food and Drug Safety (MFDS) for its oral COVID-19 treatment, Xafty®. This new clinical trial will focus specifically on high-risk patients with mild-to-moderate symptoms.

High-risk groups encompass individuals aged 60 and above, as well as adults over 19 with underlying health conditions such as diabetes, hypertension, cardiovascular disease, chronic heart and lung diseases, or those who are immunocompromised. These patients are more likely to develop severe complications if they contract COVID-19, making them a priority for healthcare authorities worldwide.

As COVID-19 cases continue to rise, the number of confirmed cases and hospitalizations is surging. More than 65% of hospitalized patients are aged 65 or older. However, there is a scarcity of treatment options that can be safely prescribed to high-risk patients. Many existing treatments have significant drug interactions, making them unsuitable for patients already taking contraindicated medications. This has created an urgent need for a safe and effective treatment specifically for high-risk patients.

Recently, the U.S. National Institutes of Health (NIH) conducted a global Phase 3 clinical trial for a Japanese COVID-19 treatment aimed at high-risk patients who cannot take Paxlovid®. Unfortunately, the trial failed to meet its primary endpoints, leaving Xafty® as the only potential treatment option. In response to this, Hyundai Bioscience swiftly prepared for a Phase 3 clinical trial targeting high-risk patients.

Xafty® has previously shown promising results in a clinical trial with 300 mild-to-moderate COVID-19 patients, demonstrating rapid improvement in all 12 symptoms. Furthermore, a separate analysis requested by the Korea Disease Control and Prevention Agency (KDCA) indicated that Xafty® was even more effective for high-risk patients on other medications for conditions such as diabetes, hypertension, and heart disease.

Motivated by these encouraging results, Hyundai Bioscience is moving forward with an additional Phase 3 clinical trial focused solely on high-risk COVID-19 patients. The new trial will significantly increase the number of participants from 120 to 290, with 145 in both the test and control groups. Unlike previous trials that required hospitalization, this study will involve outpatient visits only, which is expected to speed up recruitment and reduce costs by 20% to 25% per patient.

Dr. Geun-Woo Jin, Executive Vice President of Hyundai Bioscience, emphasized the importance of Xafty® for high-risk patients who are unable to take Paxlovid® due to contraindicated medications. He highlighted that the failure of the Japanese COVID-19 treatment in Phase 3 trials has positioned Xafty® as the only viable solution for this urgent global need.

Mr. Oh Sang-gi, the CEO of Hyundai Bioscience, stated that the company is pursuing a dual-track strategy for Xafty®'s emergency use authorization. While continuing the current EUA process for general COVID-19 patient treatment, they will also promptly conduct an additional Phase 3 trial exclusively for high-risk patients to ensure they have access to a safe and effective treatment.

Hyundai Bioscience is a biotechnology company founded in 2000, specializing in developing new drugs using novel drug delivery systems that safely and efficiently deliver active ingredients to targeted areas of the human body. The company focuses on repurposing or expanding the indications of existing drugs using proprietary organic-inorganic hybrid technologies. Hyundai Bioscience is publicly listed on KOSDAQ in South Korea.