TAIPEI, Apr.16, 2021 — Golden Biotechnology Corp.(TPEx:4132)(“GoldenBiotech”), a leading Taiwanese biopharmaceutical company, announced that it has completed second interim of patients enrollment for its multinational Covid-19 Phase 2 clinical trial for the new drug Antroquinonol (HOCENA). The second interim sets for the cumulative number of patients admitted reaches 80. The results of the interim 2 of phase 2 trial will be announced after the review by the US FDA approved external independent data monitoring committee (DMC). The trial is currently undergoing in the United States, Peru and Argentina.
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 one of the top US medical hospitals, the Duke University Medical Center, have now successively joined the continuous enrollment of patients in clinical trial which will shorten the completion time of phase 2 clinical trial and time to obtain the US FDA emergency use authorization (EUA).
GoldenBiotech has authorized its new drug Antroquinonol (HOCENA®) for Covid-19 indication to BNC Korea for developing and marketing in South Korea, Russia, Ukraine and Turkey. Related payments from the contract will be recognized under the International Financial Reporting Standard, IFRS 15 “Revenue from Contracts with Customers” when each performance obligation is satisfied. The upfront payment from BNC Korea will be recognized revenue by GoldenBiotech when receiving EUA approval from the US FDA.
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 day] 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 day], clinical change score as measured by the WHO COVID-19 Clinical Improvement Ordinal Scale, duration of hospitalization [Time Frame: 28 day] as time for patient discharge and the “Time to virological clearance” [Time Frame: 28 day] which is measured as study days from start of treatment to first negative SARS CoV 2 PCR test.
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