[서울=뉴스핌] Reporter Jeong Gyeong-hwan = BNC Korea announced on the 20th that it had been confirmed by the Food and Drug Administration (FDA) for its efficacy and safety in relation to the first phase of clinical phase 2 in the United States of Antroquinonol, a candidate for COVID-19 treatment.
A company official said, “As a result of the review by the External Independent Data Review Committee (DMC) of the US FDA for 20 of the subjects in the phase 2 clinical trial of antroquinonol, which is being approved by the US FDA, The efficacy and safety were confirmed for hospitalized patients with mild and moderate severity,” he said. “Consent and approval was made to recruit subjects and continue the clinical trial without changing the dose or the clinical trial plan.”
The evaluation results of the external independent review committee are largely divided into four categories, which explains that the most positive results were confirmed.
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This trial, which was approved by the U.S. FDA in July last year, is a trial that compares with a randomized double-blind placebo control group. As a test drug, 200mg per day was administered orally for 14 days, and the probability of survival without invasive mechanical oxygen respiration on the 14th day was measured as the main endpoint.
An official from Golden Biotech Taiwan, a partner of BNC Korea, which has secured copyright and manufacturing rights for anthroquinonol in Russia, Turkey, Ukraine, and Korea, said, “About mild and moderate patients hospitalized with pneumonia after being infected with the corona 19 virus. Antiviral, anti-inflammatory, and anti-pulmonary fibrosis effects were confirmed through animal experiments, etc. The therapeutic effect and safety of anthroquinonol were analyzed by interim results of 20 out of clinical trial 2 subjects. It was confirmed positively.”
BNC Korea plans to convene the 2nd DMC Committee for 80 people by March this year and complete the last patient administration by the end of April.
Currently, the Phase 2 clinical trial of antroquinonol is in progress, recruiting subjects from New Jersey, Kansas, and Indiana in the United States, targeting a total of 174 patients.
A company official said, “The results of phase 2 clinical trials were successfully submitted and reviewed by the US FDA through an official from Taiwan’s Golden Biotech,” said the US FDA as a treatment for mild and moderate patients hospitalized for pneumonia caused by corona 19 virus infection. “We plan to apply for emergency use of anthroquinonol”.