Golden Biotechnology Corp., a leading Taiwanese biopharmaceutical company, announces that its Phase 2 COVID-19 trial for oral new drug Antroquinonol 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.
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 (Coronavirus SARS-CoV-2 disease). 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. The proportion of patients who are alive and free of respiratory failure (e.g., no need for invasive mechanical ventilation, non-invasive ventilation, high flow oxygen, or ECMO) on Day 14.
Antroquinonol®, a novel small molecule that was discovered in 2006 by Golden Biotechnology Corp. Its compound structure, preparation methods and applicable indications have been protected with patents worldwide. Embraced by its safety and multi-functional bioactive advantages, it has been applied in several clinical trials or research in oncology, coronavirus, cardio-vascular, auto-immune and neuro-degenerative diseases.
Golden Biotechnology Corporation, founded in 2002, is a Taiwanese based leading pharmaceutical company which dedicates to discovering novel compounds (NCE) and developing cutting-edge innovative therapeutics with breakthrough advantage against serious and rare diseases in hopes to improve and promote a lasting quality of life, health and longevity.