Antroquinonol (Hocena), an anti-cancer and anti-hyperlipidemia drug developed by a Taiwanese firm as a potential medicine to treat COVID-19, was approved by Peru's authorities to begin phase II trials, according to its developer.
Golden Biotechnology Corporation (GoldenBiotech), a pharma and supplement products manufacturer based in northern Taiwan, said in a press statement that it has received a notice from Peru's Ministry of Health that the company is allowed to carry out the phase II clinical trials of Antroquinonol on humans in the South American country.
The purpose of the trials is to evaluate the drug's efficacy and safety for patients with mild to moderate pneumonia due to COVID-19, it said, adding that the schedule on when to end the trials will be adjusted based on clinical results.
The company said it independently developed the small molecule new drug and owns 100 percent of its patent rights, therefore it can apply for market licenses after all phases of the trials are completed.
Prior to this, GoldenBiotech received the U.S. Food and Drug Administration's approval in October to conduct Phase II clinical trials of Antroquinonol on COVID-19 patients in the U.S.
International contract research organizations are commissioned to carry out phase II trials, with an estimated enrollment of 174 COVID-19 patients.
The first stage of phase II trials will involve 20 participants, according to the company.
Clinical trials have five phases. Phase II trials further assess safety as well as whether a drug works after Phase 0, which studies how a drug is processed in the body and how it affects the body. Phase I trials are aimed at finding the best dose of a new drug with the fewest side effects, according to standard practice.