TAIPEI, Feb. 4, 2021 /PRNewswire/ — Golden Biotechnology Corp.(TPEx:4132)(“GoldenBiotech”), a leading Taiwanese biopharmaceutical company, announced that it has made two achievements for its Covid-19 new drug candidate Antroquinonol® (HOCENA®): receiving positive response after DMC review in Phase 2 clinical trial and signed first agreement in global licensing progress. GoldenBiotech receives in Jan. the “Positive Response” from DMC, an US FDA approved independent Data Monitoring Committee for its Phase 2 Covid-19 trial in the USA. The clinical trial data of the first set of patients in the Phase 2 trial were unblinded and reviewed by the DMC on the request of FDA. The review approved by the DMC as the “positive response” to the clinical trial with no need of modification on the trial and can proceed the following recruitment of the patients for the treatment of mild to moderate hospitalized Covid-19 patients. According to the FDA’s guidance, the DMC advises the sponsor regarding the continuing safety of trial subjects and those yet to be recruited to the trial, as well as the continuing validity and scientific merit of the trial.
GoldenBiotech will be applying for the US Emergency Use Authorization (EUA) once the clinical trial exhibits significant clinical results which can expedite the speed of meeting of urgent market demand in the pandemic. GoldenBiotech has expanded the multi-national centers of trial to the US, Peru and Argentina to speed up the completion of the Covid-19 trial. The clinical trial will be completed the fastest in the Q2 of this year.
This Covid-19 drug candidate has been granted ODD (Orphan drug designation) approval by the US FDA in 2015 for treating AML(Leukemia), HCC(Liver Cancer) and Pancreatic Cancer and ODD Approval by European EMA for treating Pancreatic Cancer in 2017.
GoldenBiotech has started the global licensing plan of the new drug candidate Antroquinonol® (HOCENA®) for Covid-19 treatment. The first signed licensing agreement in Jan. with BNC Korea Co., Ltd, a leading South Korean company in medical device, biologicals and pharmaceuticals company is for developing and commercialization of Antroquinonol® (HOCENA®) to treat Covid-19 in four countries: S. Korea, Russia, Ukraine and Turkey.
GoldenBiotech will receive totally up to USD 18 million payments including an upfront fee of USD 4 million and the stepwise development milestone payments of up to USD 14 million. GoldenBiotech will receive subsequent commercial royalty payment 25% of sales when the drug is granted of
EUA (Emergency Use Authorization) by the US FDA or clears the new drug application (NDA) through the FDA and selling in the market to treat Covid-19 patients.
The undergoing clinical trial of new drug Antroquinonol® is a Phase 2 clinical trial for mild to moderate COVID-19 hospitalized patients. The primary outcome measure is the proportion of patients alive and free of respiratory failure on Day 14. This is the first and only Taiwanese new drug approved by the USA, Peru and Argentina for the Covid-19 trial. Antroquinonol® has shown anti-viral, anti-inflammatory and anti-fibrotic characteristics in past animal studies, suggesting high likelihood in becoming successful treatment option for coronavirus-induced pneumonia. Other indications of clinical trials for Antroquinonol® (HOCENA®) are pancreatic cancer, NSCLC(Lung cancer), AML(Leukemia), Hyperlipidemia, Atopic dermatitis and Hepatitis B etc.
Currently there is no drug in development for treating Covid-19 that can effectively improve the severe inflammatory response induced by the virus or the overall survival rate. 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.
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.
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.