Antroquinonol, Expected Effect on BA.5 Variant... US FDA Emergency Use Authorization Pre-Consultation Application

[Asia Economy Reporter Hyungsoo Park] Korea BNC stated that 'Antroquinonol,' a COVID-19 treatment developed by Taiwan's Golden Biotech, shows both anti-inflammatory and anti-pulmonary fibrosis effects, and is expected to be effective against variant viruses.

As COVID-19 cases increase, the BA.5 variant, derived from the Omicron BA.1 and BA.2 variants, is emerging as the dominant strain. BA.5 is known for its high viral infectivity. Variant viruses neutralize the effectiveness of vaccines and treatments and evade attacks such as antibodies.

Korea BNC explained, "Developing treatments targeting viral proteins that do not undergo mutations and have high interspecies conservation among variant virus proteins will be a good strategy to maintain treatment efficacy."

Korea BNC introduced that Antroquinonol, developed through Taiwan's Golden Biotech, inhibits the substrate of Rho GTPase (RAS-related GTPase activating enzyme A), which is involved in viral entry, movement, and proliferation, and also inhibits the interacting NSP7 protein. Theoretically, it is expected to block virus-mediated internal membrane remodeling and suppress the proliferation of variant viruses. NSP7 is known to maintain over 98% high conservation despite species differences in coronaviruses. It blocks the function of interferon alpha independently of cytoskeleton formation and other NSP proteins. No mutations in the NSP7 protein have been confirmed in the BA.5 or BA.2.75 variant viruses.

There is an urgent need for treatments that can simultaneously prevent respiratory infection inflammation, decreased lung function, and lung damage caused by antiviral drugs and COVID-19 virus infection. It has shown over 99% defense effectiveness against existing viruses and, based on its theoretical mechanism of action, can provide high defense against variant viruses. Antroquinonol, which possesses both anti-inflammatory and anti-pulmonary fibrosis effects, is highly promising as a COVID-19 virus treatment candidate. It also has excellent safety with minimal side effects.

Korea BNC has secured exclusive manufacturing and sales rights for Antroquinonol in Korea and four other countries. Through Taiwan's Golden Biotech, the Phase 2 clinical trial approved by the U.S. FDA was completed in December last year. They are preparing to apply for Emergency Use Authorization (EUA) from the U.S. FDA. On the 7th, they completed the pre-consultation application submission with the U.S. FDA. The FDA has confirmed receipt and will preliminarily review the adequacy of the data submitted by Taiwan's Golden Biotech over a certain period.

Following the preliminary review results, an EUA application will be submitted, and after the U.S. FDA's final review, Emergency Use Authorization is expected to be obtained. Once approved by the U.S. FDA, Antroquinonol will be supplied after approval procedures in each country.

This content was produced with the assistance of AI translation services.