Golden Biotechnology Corp.(TPEx:4132) (“GoldenBiotech”, GBC), a leading Taiwanese biopharmaceutical company, announces that its Phase 2 COVID-19 trial for oral new drug Antroquinonol (HOCENA®) has achieved 100% recovery results of its primary outcome measure in hospitalized mild, moderate including ICU severe patients. In line with the plan, GoldenBiotech will submit the final clinical trial analysis report and related R&D documents to the US FDA to apply for emergency use authorization (EUA) for Antroquinonol (HOCENA®).
This trial is a Phase 2 randomized, double-blind, placebo-controlled study to evaluate the safety and efficacy of Antroquinonol in hospitalized patients with mild to moderate pneumonia due to COVID-19 (Coronavirus SARS-CoV-2 disease). Actually, the trial also included the ICU severe patients who need oxygen support. Following completion of all screening assessments and meeting of eligibility criteria, patients will either receive 100mg of Antroquinonol or placebo two times a day for 14 days in combination with Standard of Care (SoC) therapy per local SoC policies. The trial completed recruiting for 124 patients in the USA, Peru and Argentina where the new pandemic upheaval is rampant with highly transmitted SARS-CoV-2 variants.
The clinical trial data revealed:
- Primary Outcome Measure: recover ratio [Time Frame: 14 days]
The proportion of patients who are alive and free of respiratory failure (e.g., no need for invasive mechanical ventilation, non-invasive ventilation, high flow oxygen, or ECMO) on Day 14.
Result: In the Antroquinonol group, the recovery ratio was 97.9% at the day 14 visit. Furthermore, no death or respiratory failure was found in the Antroquinonol group at the day 28 visit with recovery ratio of 100%.
- Secondary Outcome Measures:
(a) Duration of ICU Stay:
Result: The median duration of ICU stay in Antroquinonol group was 9.5 days shorter than that in the placebo group.
(b) Duration of hospitalization [ Time Frame: 28 days]: time for patient discharge.
Result: The median duration of hospitalization was 4 days in the Antroquinonol group.
(c) Time to 2-point improvement [ Time Frame: 28 days]: Clinical change score as measured by the “WHO COVID-19 Clinical Improvement Ordinal Scale”.
Result: The median time to score of 0 in “WHO COVID-19 Clinical Improvement Ordinal Scale” was 29 days in the antroquinonol group.
(d) Time to virological clearance [ Time Frame: 28 days]: measured as study days from start of treatment to first negative SARS-CoV-2 PCR test.
Result: The median time to virological clearance was 14 days in the Antroquinonol group.
In safety evaluation, the data revealed that Antroquinonol showed good tolerability and safety results.
ClinicalTrials.gov Identifier: NCT04523181