Korea BNC "Expecting Expansion of Antroquinonol COVID-19 Treatment Application"

[Asia Economy Reporter Hyunseok Yoo] Taiwanese company Golden Biotech has received approval from the U.S. Food and Drug Administration (FDA) through its clinical trial contract research organization (CRO) to expand the recruitment of subjects in ongoing clinical trials to include not only mild and moderate COVID-19 hospitalized patients but also severe patients requiring non-invasive ventilation or high-concentration oxygen.

According to Korea BNC on the 30th, Golden Biotech received consent from the U.S. FDA on the 29th to expand subject recruitment.

Regarding the ongoing Phase 2 clinical trial approved by the U.S. FDA, Golden Biotech submitted an application in July to amend the clinical trial protocol to include severe patients, and the FDA did not reject or raise any issues.

On June 3rd, the second independent Data Monitoring Committee (DMC) review of 80 dosed subjects confirmed the efficacy and safety of Antroquinonol in patients hospitalized with mild to moderate COVID-19 infection. Consent and approval were granted to continue subject recruitment and the clinical trial without any dosage changes or protocol amendments. It was recommended to expand the subject selection criteria from mild to moderate COVID-19 hospitalized patients to include severe patients requiring non-invasive ventilation and high-concentration oxygen. The protocol amendment to include severe patients was submitted to the FDA in July.

This means that the scope of Antroquinonol for hospitalized COVID-19 patients has been expanded from mild and moderate cases to include severe cases. If the Phase 2 clinical trial is successfully completed as planned, an emergency use authorization application will be submitted based on the results. If approved, the usage scope of Antroquinonol will be expanded, indicating a larger target market for the treatment.

The Phase 2 clinical trial results for Antroquinonol will be reviewed in the third quarter, and if positive, an emergency use authorization application will be submitted to the U.S. FDA based on the clinical trial report.

Korea BNC holds exclusive manufacturing and sales rights for Antroquinonol in Korea, Russia, Turkey, and Ukraine, and is collaborating with Taiwanese Golden Biotech to develop a COVID-19 treatment.

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