Taiwanese biopharmaceutical company Golden Biotechnology Corp. on Wednesday released positive interim unblinded data from the Phase 2 clinical trial of its oral investigational new drug for COVID-19 Antroquinonol, and announced it plans to apply for Emergency Use Authorization (EUA) in the United States in April.
Antroquinonol is the only Taiwanese new drug candidate against COVID-19 that produced positive results in hospitalized patients with confirmed COVID-19 infections in a Phase 2 clinical trial, company chairman Alex Liu (???) told a media briefing.
The results from the Phase 2 trial demonstrate the safety and tolerability of Antroquinonol in patients, according to the company.
The multi-national phase 2 clinical trial was conducted in the United States, Peru and Argentina, the company said.
The first global participant for Antroquinonol’s Phase 2 clinical trial was recruited on Oct. 16, 2020 and a total of 124 patients were enrolled in the trial that ended in the fourth quarter of 2021, according to the company.
The trial for treating mild-to-moderate COVID-19 hospitalized patients was set as a randomized, double-blinded and placebo-controlled study.
In the trial, patients either received Antroquinonol or a placebo for 14 days in combination with standard of care (SoC) therapy per local SoC policies.
The company has unblinded the results of its Phase 2 clinical trial, which showed that of those taking the drug, 97.9 percent of patients recovered on the 14th day after drug exposure, it said.
The overall patient recovery rate was 100 percent on the 28th day after drug exposure, while no deaths or respiratory failure cases reported, according to the company.
The design of the Phase 3 trial will be similar to that of Phase 2, but will enroll about 500-600 participants and involve patients with breakthrough infections and non-hospitalized patients, the company said.
The company added that it also plans to expand the multi-national trial to South Korea, Singapore and Europe in Phase 3 and boost the total number of trial centers to at least 50.
Golden Biotechnology estimates the Phase 3 trial will cost it US$50 million-US$80 million.
The company signed a licensing agreement with BNC Korea Co., Ltd, last year for the development and commercialization of Antroquinonol to treat COVID-19 patients in four countries — South Korea, Russia, Ukraine and Turkey.
On Aug. 24, 2021, it signed a memorandum of understanding with Austrian pharmaceutical company Sanova Pharma GesmbH for cooperation and development related to Antroquinonol in 23 European countries including Austria, the United Kingdom, Italy, Norway, Denmark and Switzerland.
Source: Focus Taiwan News Channel