"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 option.