Hyundai Bio Oral Treatment Completes Phase 1 Clinical Trial... "Safety Proven"

Hyundai Bioscience is developing 'CP-COV03' as a treatment for COVID-19. (Photo by Hyundai Bioscience)

[Asia Economy Reporter Lee Chun-hee] The clinical trial for 'CP-COV03,' an oral COVID-19 treatment based on niclosamide developed by Hyundai Bioscience, has been completed. The company stated that not only safety but also high bioavailability have been proven.

Hyundai Bioscience announced on the 10th that the phase 1 clinical trial results of the oral antiviral drug CP-COV03 showed about a fivefold improvement in bioavailability compared to the base drug niclosamide, and there was no significant difference in safety compared to the control group. Hyundai Bioscience submitted the phase 1 clinical trial report containing these details to the Ministry of Food and Drug Safety the day before.

The clinical trial was conducted at the Catholic University Seoul St. Mary's Hospital with a total of 17 participants. Eleven subjects in the test group received a single dose of Hyundai Bioscience's CP-COV03-T (niclosamide 50 mg), while six subjects in the control group took a single dose of the existing niclosamide 500 mg tablet.

Considering this difference in dosage, Hyundai Bioscience explained that when standardized, CP-COV03 showed a 4.09-fold increase in the area under the blood concentration-time curve (AUClast) and a 5.5-fold increase in the maximum blood concentration (Cmax) compared to the control drug. The niclosamide metabolite, 3-hydroxy niclosamide, also showed a 3.11-fold increase in AUClast and a 4.68-fold increase in Cmax when compared on a dose-standardized basis. However, Hyundai Bioscience added, "This clinical trial is exploratory in nature to understand the pharmacokinetic characteristics of the test and control drugs," and "statistical significance was not verified."

In terms of safety, neither the test drug nor the control drug groups experienced serious adverse reactions or drug-related adverse events, and no clinically significant changes were observed between the two groups in vital signs or physical examinations.

Jin Geun-woo, head of research at Hyundai Bioscience, said, "The key to antiviral drugs is a 'sustained-release formulation' that maintains the drug in the bloodstream at an effective concentration for a long time," adding, "It is meaningful that the fivefold improvement in bioavailability confirmed in animal experiments appeared at almost the same level in clinical trials."

Hyundai Bioscience has applied for phase 2 clinical trials of CP-COV03. By integrating phases 2a and 2b, they plan to shorten the clinical trial period as much as possible and increase the number of patients to apply for emergency use authorization as soon as possible.

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