Hyundai Bio Advances Integrated Phase 2 Clinical Trial for COVID-19 Oral Antiviral

[Asia Economy Reporter Ji-hwan Park] Hyundai Bio announced on the 7th that it will proceed with the Phase 2 clinical trial of the oral antiviral candidate drug ‘CP-COV03,’ being developed as a treatment for COVID-19, by integrating Phase 2a and Phase 2b without dividing them.

Hyundai Bio stated that it consulted with relevant authorities following recent experimental results from a government-affiliated research institute showing that CP-COV03 demonstrates excellent efficacy against the currently prevalent Omicron variant. The Phase 2 clinical trial plan will be submitted to the Ministry of Food and Drug Safety soon.

According to recent experimental results conducted by the National Institute of Health under the Korea Disease Control and Prevention Agency, the host-targeting antiviral CP-COV03 showed a blood effective drug concentration (IC100) that completely inhibits virus replication against Omicron at less than 0.65μM (micromolar). This is only about one-third of the IC50 value of 1.75μM for COVID-19.

These experimental results indicate that CP-COV03 exhibits much superior antiviral efficacy against the Omicron variant compared to COVID-19. Hyundai Bio plans to verify the results of both 5-day and 3-day administration in the Phase 2 clinical trial experimental group of CP-COV03.

Jin Geun-woo, head of research at Hyundai Bio, said, "The National Institute of Health’s experimental results confirmed that CP-COV03 can completely inhibit the Omicron virus at about one-third the concentration that inhibits 50% of the original COVID-19 virus," adding, "This shows that CP-COV03 can suppress virus replication of the Omicron variant much more effectively than COVID-19, potentially shortening the treatment period."

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