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.
DATROWAY receives US priority review for first-line metastatic triple negative breast cancer
Lupin launches Dasatinib tablets in US market
Natera submits Signatera CDx PMA to FDA for bladder cancer use
Pharming receives FDA complete response letter for paediatric Joenja application
Trace Biosciences' IND application for nerve-specific imaging agent approved by FDA
Frontage expands early phase clinical research capabilities across US and China
MicuRx Pharmaceuticals' IND application for MRX-5 cleared by FDA
FDA approves Tenpoint Therapeutics' YUVEZZI as first dual-agent eye drop for presbyopia
Summit Therapeutics' BLA for ivonescimab in EGFR-mutated NSCLC accepted by FDA
WuXi Biologics collaborates with Sinorda Biomedicine for antibody development
Biogen's litifilimab receives FDA Breakthrough Therapy Designation for CLE
Glaukos receives FDA approval for repeat administration of iDose TR
Guerbet's contrast agent Elucirem approved by European Commission in children from birth
Spine Innovation's LOGIC Titanium Implant System receives US FDA 510(k) market approval