A drug candidate developed by Golden Biotechnology Corp is to enter phase 2 clinical trials patients in the US for treatment of severely ill COVID-19, pending authorization by the authorities, the Taiwanese drugmaker said.
The drug, called antroquinonol, is undergoing phase 2 clinical trials in the US, Peru and Argentina, where 174 hospital patients with mild to moderate COVID-19 symptoms are enrolled in the double-blind placebo study, the company said in statement on Wednesday last week.
Preliminary results of the phase 2 trials in the US were commended by an independent data monitoring committee assigned to the trials by the US Food and Drug Administration (FDA), said Golden Biotech, one of Taiwan’s leading biopharmaceutical companies.
The committee recommended that the phase 2 trials also include severely ill COVID-19 patients undergoing non-invasive ventilation or high-flow oxygen therapy, the firm said.
Golden Biotech chief executive officer Today Su (蘇經天) said that the drugmaker would forward the recommendation to the FDA.
If approved, Golden Biotech would finish phase 2 trials in the third quarter of this year and then seek emergency use authorization (EUO) in the US, Su said.
Antroquinonol was independently developed by Golden Biotech, which holds full patent rights, Su said.
First approved in the US for treatment of leukemia, and liver and pancreatic cancer in 2015, antroquinonol was in 2017 also approved for pancreatic cancer treatment by European authorities.
Golden Biotech in October last year received approval to conduct phase 2 trials for COVID-19 treatment in the US.
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