Hyundai Bio Plans Integrated Phase 2 Clinical Trial for COVID-19 Oral Drug 'CP-COV03'

Goal to apply for emergency use authorization next month by increasing participating patients
Separate confirmation of drug efficacy with '3-day administration' planned in Phase 2 clinical trial

[Asia Economy Reporter Lee Gwan-joo] Hyundai Bio plans to conduct the Phase 2 clinical trial of its oral antiviral candidate drug for COVID-19 treatment, 'CP-COV03,' as an integrated process without dividing it into Phase 2a and 2b.

On the 7th, Hyundai Bio stated, "We plan to apply for emergency use authorization for CP-COV03 by next month at the latest," adding, "To enable emergency use authorization for CP-COV03, we will increase the number of patients participating in the Phase 2 trial and conduct the trial by integrating Phase 2a and 2b."

Hyundai Bio plans to submit this Phase 2 clinical trial plan to the Ministry of Food and Drug Safety after consultations with relevant agencies, based on experimental results from the National Institute of Health showing that CP-COV03 is effective against the Omicron variant.

In recent efficacy and toxicity tests conducted by the National Institute of Health, the host-targeting antiviral CP-COV03 maintained its IC50 (blood drug concentration inhibiting 50% of virus replication) at one-quarter of the concentration required to inhibit other COVID-19 related viruses, and at one-third concentration, it was confirmed to inhibit 100% of Omicron replication. The IC100 (blood effective drug concentration inhibiting 100% of virus replication) for Omicron was below 0.65 μM (micromolar), approximately one-third of the IC50 value of 1.75 μM for COVID-19.

Hyundai Bio explained that these experimental results indicate that CP-COV03 exhibits significantly superior antiviral efficacy against the Omicron variant compared to the original COVID-19 virus. Hyundai Bio also plans to verify the results of both 5-day and 3-day administration in the Phase 2 clinical trial experimental group for 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 inhibit 100% of the Omicron virus even at one-third the concentration that inhibits 50% of the original COVID-19 virus," adding, "This shows that CP-COV03 can more effectively suppress virus replication in the Omicron variant than in COVID-19, potentially shortening the treatment period."

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