Hyundai Bio's COVID-19 Treatment Development Progresses Smoothly... Inhibits 99% Proliferation Within Non-Toxic Limits

[Asia Economy Reporter Hyungsoo Park] Simulation results have shown that the oral antiviral drug for COVID-19, CP-COV03, can maintain the maximum effective drug concentration that virtually suppresses Omicron virus replication by 100% within the maximum non-toxic limit (NOAEL) in the human body, even after repeated administration for 5 days.

Hyundai Bio announced that as a result of a 'Monte Carlo (multiple probability) simulation' for phase 2 clinical trials, CP-COV03 maintained the maximum effective blood drug concentration (EC99) that suppresses Omicron virus replication by more than 99% within the NOAEL limit throughout the 5-day dosing period.

To find the optimal dosage and administration method of CP-COV03 in phase 2 clinical trials, a simulation was recently conducted by a drug evaluation system development professor team at the Ministry of Food and Drug Safety, based on preclinical data and phase 1 clinical trial results.

The simulation results showed that CP-COV03 can safely cure the disease without side effects due to toxicity accumulation even after repeated administration for 5 days in COVID-19 patients participating in phase 2 clinical trials. Hyundai Bio plans to verify the cure after 3 days of administration in phase 2 clinical trials as well.

The EC99 (effective concentration 99) concentration corresponds to the IC100 (inhibitory concentration 100) concentration that suppresses virus replication by 100%. Pfizer’s Paxlovid has been disclosed in papers to maintain blood concentrations above EC90 in the human body.

CP-COV03 demonstrated through animal experiments in December two years ago that a single dose maintains the IC100 concentration for more than 12 hours.

Hyundai Bio plans to submit the simulation results to the Ministry of Food and Drug Safety to apply them to phase 2 clinical trials. The Monte Carlo simulation applied to clinical drugs by the U.S. Food and Drug Administration (FDA) and Korea’s Ministry of Food and Drug Safety is a technique used to find the optimal dosage and administration method, targeting 1,000 virtual subjects.

Since Tamiflu, which was a game changer during the H1N1 flu pandemic, Pfizer’s antiviral drug is known to be the only one that has continuously maintained blood drug concentrations above EC90 during repeated dosing periods.

Dr. Jin Geunwoo, head of Hyundai Bio’s research institute, explained, "For antiviral drugs, it is important to maintain the effective blood concentration with a single dose, but the key is whether the effective concentration can be maintained within the NOAEL limit even after repeated dosing for 5 days."

He added, "The more the drug is administered repeatedly for 5 days, the higher the peak concentration of the drug increases, so it is difficult to maintain EC99 within the NOAEL limit. CP-COV03 has confirmed that it maintains EC99 throughout the 5-day dosing period."

Among antiviral drugs for COVID-19, only Pfizer’s Paxlovid continuously maintains the IC100 (EC99) concentration during the dosing period. It is known that this is not easy to achieve without support from cutting-edge technology.

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