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.
TiumBio files Clinical Trial Application to start Phase 1b TU7710 study
Moderna reports positive interim results from next-generation COVID-19 vaccine trial
Scancell initiates SCOPE trial's iSCIB1+ cohort
Valneva launches Phase 1 trial for next-generation Zika vaccine
argenx obtains VYVGART approval for primary immune thrombocytopenia in Japan
Bio-Thera Solutions' BAT8006 phase II Study receives US FDA IND approval