Jinwon Life Sciences Receives EMA and Bulgaria Approval for Phase 2 IND of Oral COVID-19 Treatment

[Asia Economy Reporter Jang Hyowon] Genexine announced on the 1st that its oral COVID-19 treatment GLS-1027, which prevents clinical deterioration in patients hospitalized with COVID-19 symptoms, has received approval for a Phase 2 clinical trial from the European Medicines Agency (EMA) and the Bulgarian regulatory authority.

This clinical trial is a randomized, placebo-controlled, double-blind Phase 2 study that has already been approved in the United States, South Korea, and North Macedonia, and will be conducted at a total of 12 institutions including Europe (Bulgaria).

Genexine revealed through hamster challenge infection studies that GLS-1027 not only reduced pneumonia caused by the originally discovered COVID-19 virus but also significantly decreased pneumonia caused by the Beta variant found in South Africa, which is highly resistant to vaccines. It also excellently reduced virus-induced syncytium formation and cytopathic effects, pathological features of severe pneumonia.

Park Young-geun, CEO of Genexine, stated, “This is the first case of our company receiving Phase 2 approval from the EMA, marking a very important milestone as the target for domestic sales and global marketing expands not only to the United States but also to Europe. Since Bulgaria is experiencing the third major wave of COVID-19, recruitment for the multinational clinical trial of GLS-1027 is expected to proceed rapidly.”

This content was produced with the assistance of AI translation services.