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.
UroGen's UGN-103 IND accepted by FDA for bladder cancer treatment
MaaT Pharma reveals positive 18-month data for MaaT013 in GI-aGvHD
Innate Pharma advances Sanofi-developed NK cell engager to Phase 2 for blood cancer patients
Soligenix receives orphan drug designation from FDA for active ingredient in SuVax
Candel Therapeutics granted FDA Orphan Drug Designation for CAN-2409 in pancreatic cancer treatment
Lipogems completes patient enrolment in ARISE I US FDA IDE study
Amylyx Pharmaceuticals' AMX0035 shows promising impact on Wolfram syndrome symptoms
Roche attains CE Mark for first companion diagnostic for HER2-low metastatic breast cancer
Cadrenal Therapeutics' tecarfarin receives US FDA Orphan Drug Designation
BioCity Biopharma's BC2027 Phase one study IND application receives US FDA approval
Seres Therapeutics completes patient enrollment for SER-155 Phase 1B trial