Hyundai Bio Proves 'Safe Drug' in Oral COVID-19 Treatment Clinical Trial

[Asia Economy Reporter Park Ji-hwan] Hyundai Bio's oral antiviral CP-COV03 for COVID-19 has been proven to be safe and highly bioavailable in humans following animal studies.

Hyundai Bio announced on the 10th that the Phase 1 clinical trial conducted at the Catholic University Seoul St. Mary's Hospital showed that CP-COV03 improved bioavailability by approximately five times compared to the base drug niclosamide. In terms of safety, no significant difference was observed compared to the control group. Hyundai Bio submitted the Phase 1 clinical trial report to the Ministry of Food and Drug Safety on the 9th.

Through pharmacokinetic analysis in the blood, CP-COV03 has established a basis for determining the appropriate dosage in Phase 2 clinical trials. Notably, CP-COV03 is the first to demonstrate improved bioavailability of niclosamide?a major challenge in drug repositioning?at the clinical stage, increasing its potential success as a COVID-19 treatment.

Jin Geun-woo, head of research at Hyundai Bio, explained, "CP-COV03 can increase niclosamide bioavailability up to 43 times, but the key for antivirals is a 'sustained-release formulation (徐放性 ?形)' that maintains effective drug concentration in the blood for an extended period." He added, "It is significant that the fivefold improvement in bioavailability observed in animal experiments with the same formulation was almost identically confirmed in clinical trials."

Bioavailability refers to the proportion of an orally administered drug that enters systemic circulation and is available for use in the body. Since effective blood concentrations vary by disease, the bioavailability of oral therapeutics must be adjusted within safe ranges according to each condition.

Having improved CP-COV03's bioavailability up to 43 times that of niclosamide, Hyundai Bio plans to develop customized formulations for different diseases and actively pursue various drug repositioning opportunities based on CP-COV03.

Hyundai Bio intends to sequentially expand the applications of CP-COV03 beyond COVID-19 treatment to include several cancers such as ovarian and prostate cancer caused by p53 mutations, as well as intractable diseases like lupus and amyotrophic lateral sclerosis (ALS).

After applying for Phase 2 clinical trials of CP-COV03 on the 21st of last month, Hyundai Bio plans to increase patient enrollment to enable emergency use authorization application by March and to shorten the clinical trial period as much as possible by integrating Phase 2a and 2b trials.

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