Golden Biotechnology Corp (GBC, 國鼎) plans to apply for emergency use authorization in the US for its experimental COVID-19 drug after positive results in its phase 2 clinical trials, the company said.
GBC on Wednesday announced some of the results from randomized, double-blind and placebo-controlled studies in phase 2 clinical trials of its COVID-19 oral drug antroquinonol, dubbed Hocena, for the treatment of people hospitalized with mild-to-moderate COVID-19 symptoms.
In the trials, 97.9 percent of people recovered by the 14th day after being given the drug and all participants recovered by the 28th day, GBC spokesman Alan Tseng (曾木增) said yesterday.
Photo: Chen Yung-chi, Taipei Times
“Recovered” meant that participants did not have respiratory failure, and thus did not require ventilation, high-flow oxygen or extracorporeal membrane oxygenation, Tseng said.
The median length of hospitalization for those in the experimental group was four days, 20 percent shorter than for those in the control group, the company said.
Of the five participants in intensive care due to serious COVID-19 symptoms, the median length of treatment for those given the drug was 13.5 days, 9.5 days shorter than for those given the placebo, it said.
The median period in which those in the experimental group first tested negative for COVID-19 after receiving the drug was 14 days, the company said.
The full test results would be disclosed after GBC receives a report from Labcorp Drug Development, a US-based contract research organization that helped conduct the human trials, the company said.
The trials began in October 2020 and were conducted in Argentina, Peru and the US, it said.
GBC recruited 124 participants, despite initially planning to enroll 174.
“But the results of phase 2 clinical trials should be meaningful statistically once the number of participants exceeds 100,” GBC chairman Liu Sheng-yung (劉勝勇) said.
“Over the past year, the coronavirus mutated quickly and we have witnessed breakthrough infections, which occur when a fully vaccinated person contracts the disease,” Liu said, adding that the ratio of people with breakthrough infections to all of those infected with COVID-19 had surpassed 60 percent and is expected to continue rising.
“However, so far, no company has claimed that its drug can repel breakthrough infections, so we think it is necessary to test our drug against breakthrough infections in our phase 3 clinical trials,” Liu said. “So we are under time pressure” to finish phase 2 trials and begin phase 3.
GBC was the nation’s second biotech company to complete phase 2 human trials on an oral COVID-19 treatment, after Senhwa Biosciences Inc (生華科) in October last year.
GBC shares yesterday surged 50 percent to NT$212.22 on the Emerging Stock Board, up from NT$54 a year earlier, Taipei Exchange data showed.
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