Anti-viral and Anti-Inflammatory Response: GoldenBiotech's Antroquinonol Receives FDA Approval on COVID-19 Phase 2 Trial in USA

TAIPEI, July 1, 2020 /PRNewswire/ -- Golden Biotechnology Corp. (GoldenBiotech, 4132.TWO), a leading Taiwanese biopharmaceutical company, announced that the FDA approved its investigational new drug (IND) application for a Phase II clinical trial of Antroquinonol (Hocena®) on COVID-19 patients in USA. GoldenBiotech has also applied for the US BARDA (Biomedical Advanced Research and Development Administration) CoronaWatch meeting. Future developmental planning of Antroquinonol in COVID-19 include joining the COVID-19 Candidate and Technologies Portal of the National Institutes of Health (NIH) and applying for the US emergency authorization (EUA) once it exhibits significant clinical results, all to expedite the meeting of the urgent market demand.

The Phase II trial will be a randomized, double-blinded, placebo-controlled study of Antroquinonol as a potential treatment option for mild-to-moderate pneumonia in COVID-19 patients, as measured by the proportion of patients alive and free of respiratory failure (i.e., need for invasive mechanical ventilation, non-invasive ventilation, high-flow oxygen, or extracorporeal membrane oxygenation [ECMO]) on Day 14.

Dr. Today Su, Chief Executive Officer at GoldenBiotech, stated, "At present, physician can only provide supportive care such as oxygen supplementation, mechanical ventilation, and/or extracorporeal membrane oxygenator (ECMO) based on the clinical symptoms of the patients or enroll them in available clinical trials. Clearly, new and more effective drugs are still in need to fight the pandemic. Thus, it is imperative to provide immediate and ample supply to the world should our study improve the efficacy of any newly authorized treatments recommended as standard of care (SoC) for COVID-19."

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.

For other oncology indications, the Antroquinonol monotherapy study in Stage IV NSCLC patients who have failed at least two lines of anti-cancer therapy has shown longer progression free survival (PFS) and a high disease control rate. A Phase I/II study is currently in progress to evaluate the treatment efficacy of combining Antroquinonol with Nab-paclitaxel and Gemcitabine for the first-line treatment for stage IV metastatic pancreatic cancer patients. The ongoing Phase II study in relapsed AML patients who are restricted from intensive therapy showed positive preliminary results.

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SOURCE Golden Biotechnology Corp.