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Golden Biotechnology Corp., a leading Taiwanese biopharmaceutical company, has announced that its Phase 2 COVID-19 trial for oral new drug Antroquinonol (HOCENA) has achieved 100% recovery results of its primary outcome measure in hospitalized mild, moderate including ICU severe patients.
In line with the plan, GoldenBiotech will submit the final clinical trial analysis report and related R&D documents to the US FDA to apply for emergency use authorization (EUA) for Antroquinonol (HOCENA).
This trial is a Phase 2 randomized, double-blind, placebo-controlled study to evaluate the safety and efficacy of Antroquinonol in hospitalized patients with mild to moderate pneumonia due to COVID-19.
Actually, the trial also included the ICU severe patients who need oxygen support. Following completion of all screening assessments and meeting of eligibility criteria, patients will either receive 100mg of Antroquinonol or placebo two times a day for 14 days in combination with Standard of Care (SoC) therapy per local SoC policies.
The trial completed recruiting for 124 patients in the USA, Peru and Argentina where the new pandemic upheaval is rampant with highly transmitted SARS-CoV-2 variants.
