TAIPEI, Oct.12, 2020 — Golden Biotechnology Corp. (GoldenBiotech, 4132.TWO), a leading Taiwanese biopharmaceutical company, announced that its assigned Phase 2 Covid-19 clinical trial CRO ( contract research organization ) company has signed the “ Clinical Trial Agreement” with Via Christi Research, a division of Ascension Via Christi Hospitals Wichita, Inc. in Kansas, USA to conduct the recruiting and clinical trial for Covid-19 patients. FDA has already approved Golden Biotechnology Corp.’s investigational new drug (IND) application for a Phase 2 clinical trial of Antroquinonol (Hocena®) on COVID-19 patients in USA which is by far the first and only Taiwanese pharmaceutical company that was granted by FDA to conduct such trial in USA.
At present, there is no formally approved drug for SARS-Cov-2 coronavirus (Covid-19) pneumonia in the world, only the Remdesivir has obtained the U.S. FDA Emergency Use Authorization (EUA) for the treatment of patients with Covid-19 pneumonia. According to the analysis of SVB Leerink , the sales of Remdesivir in 2020 are estimated to be US$1.9 billion and will reach US$7.6 billion in 2022.
Currently there is no drug in development for treating Covid-19 that can effectively improve the severe inflammatory response induced by the virus nor the overall survival rate. We can see that by far there is no single drug that can simultaneously fight against the COVID-19 virus (SARS-CoV2) and the symptoms induced. Combination therapies adopted by other clinical trials may solve the shortcomings of single-drug therapies with slightly better efficacy, but the higher risk of adverse effects is inevitable.
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 with Antroquinonol when treating mice with excessive inflammation. The characteristic of multiple effects makes Antroquinonol more advantageous than other antiviral and/or anti-inflammatory drugs. GoldenBiotech is now actively promoting the Phase II study for COVID-19 in the hopes that Antroquinonol will not only improve the symptoms of COVID-19, but also minimize the possible side effects that may be induced during the treatment process.
The Phase 2 trial will be a randomized, double-blinded, placebo-controlled study of Antroquinonol as a potential treatment option for study in hospitalized patients with mild to moderate pneumonia due to COVID 19 to evaluate the safety and efficacy of Antroquinonol (HOCENA). Patients will either receive antroquinonol or placebo for 14 days in combination with SoC (standard of care) therapies. New drug Antroquinonol will be in a dose of 100 mg (1 capsule) administered twice daily (BID) orally for 14 days. The interventional clinical trial will enroll 174 participants in all testing sites including Ascension Via Christi Hospitals.
The Primary Outcome Measure of the study will evaluate the “recover ratio” in a time frame of 14 days to check 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. While the Secondary Outcome Measures are checking in the time frame of 28 days for patients. They are covering the “Time to 2-point improvement“ which is the clinical change score as measured by the WHO COVID-19 Clinical Improvement Ordinal Scale; “duration of hospitalization”-time for patient discharge; and the “time to virological clearance” which is measured as study days from start of treatment to first negative SARS CoV 2 PCR test.