Policy & Regulation
GoldenBiotech wins FDA approval to begin Phase 2 trial of Antroquinonol in COVID-19 patients in the US
2 July 2020 -

Taiwanese biopharmaceutical company Golden Biotechnology Corp disclosed on Wednesday the receipt of approval from the US FDA for its investigational new drug (IND) application for the randomized, double-blinded, placebo-controlled Phase II clinical trial of Antroquinonol (Hocena) for the treatment of mild-to-moderate pneumonia in COVID-19 patients in the US.

The company is now actively promoting the Phase II study for COVID-19 to improve the symptoms of COVID-19 as well as minimize the possible side effects induced during the treatment process. It has applied for the US BARDA's CoronaWatch meeting, the COVID-19 Candidate and Technologies Portal of the National Institutes of Health (NIH) as well as the US emergency authorization (EUA) once Antroquinonol exhibits the significant clinical results in COVID-19 patients.

According to the company, Antroquinonol was found to reduce viral nucleic acid replication and viral protein synthesis in both cell and animal experiments. Prevention of organ and tissue damage was also observed when treating mice with excessive inflammation.

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