Golden Biotechnology Corp.(TPEx:4132) (“GoldenBiotech”, GBC), a leading Taiwanese biopharmaceutical company, announces that its investigational new drug HOCENA(antroquinonol) has been granted the ” Compassionate Use ” on July 1st by Taiwan FDA to be used in the treatment of mild to moderate Covid-19 patients in the applied hospital. The first approval allowing for 100 patients to receive the treatment courses.
In Jun, 2021, the new drug passed the second DMC review in the USA for its enrollment of 80 patients and received the recommendation that the trial can continue without modification and extend to enroll the severe hospitalized patients (non-invasive ventilation or high flow oxygen). Currently the multinational Covid-19 Phase 2 clinical trial is undergoing in the US, Peru and Argentina for the mild to moderate hospitalized Covid-19 patients. The DMC review was conducted by the US FDA approved external independent data monitoring committee (DMC). The trial is currently undergoing in 15 trial centers covering the United States, Peru and Argentina totally
Totally 174 patients will be enrolled in the Phase 2 Covid-19 trial for Antroquinonol (HOCENA®). The result of first interim of 20 patients admitted has been reviewed by DMC and received “positive response” from DMC on January 16. For the expansion of the trial, 15 medical centers including top US medical hospitals which will shorten the completion time of phase 2 clinical trial and time to apply the US FDA emergency use authorization (EUA) when the significant trial results are achieved.
The Phase 2 trial is a randomized, double-blinded, placebo-controlled study of Antroquinonol as a potential treatment option for mild-to-moderate pneumonia in COVID-19 patients. The Primary Outcome Measures of the trial set to check the “Recovery Ratio” [Time Frame: 14 days] for the proportion of patients who are alive and free of respiratory failure (e.g., no need for invasive mechanical ventilation, noninvasive ventilation, high flow oxygen, or ECMO) on Day 14. The Secondary Outcome Measures set to check the “Time to 2-point improvement” [Time Frame: 28 days], clinical change score as measured by the WHO COVID-19 Clinical Improvement Ordinal Scale, duration of hospitalization [Time Frame: 28 days] as time for patient discharge and the “Time to virological clearance” [Time Frame: 28 days] which is measured as study days from start of treatment to first negative SARS CoV 2 PCR test.
About Antroquinonol® (HOCENA®)
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.
About Golden Biotechnology Corp. (“GoldenBiotech”)
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.