Hyundai Bio Receives Opinion to Continue Phase 2 Clinical Trial of COVID-19 Treatment Candidate 'CP-COV03'

[Asia Economy Reporter Lee Gwanju] Hyundai Bio announced on the 25th that its COVID-19 treatment candidate substance 'CP-COV03' received an opinion of 'clinical continuation' in the interim evaluation of the Phase 2 clinical trial.

Hyundai Bio stated that it received this opinion after the Data Safety Monitoring Board (DSMB) completed the review of the results from the first round of the Phase 2 clinical trial of CP-COV03 involving 36 clinical participants.

The DSMB is composed for each clinical trial and consists of independent external experts who review potential risks to participant safety and recommend either 'clinical continuation' or 'termination.' The DSMB evaluates not only the safety of the drug but also its efficacy, and if no efficacy is found, it can recommend clinical trial termination to the sponsoring company and clinical institutions. Following this recommendation, Hyundai Bio resumed the Phase 2 clinical trial of CP-COV03 for COVID-19, which had been temporarily halted prior to the DSMB review.

The positive evaluation regarding drug safety in the DSMB's interim evaluation of the Phase 2 trial is regarded as a green light for the future progress of the clinical trial.

Hyundai Bio succeeded in increasing the bioavailability of niclosamide up to 43 times, the highest in the world, by using its advanced drug delivery technology, and based on this, developed 'CP-COV03,' proving its safety and efficacy through animal experiments and Phase 1 clinical trials.

CP-COV03 is a 'cell-targeted' antiviral agent that promotes autophagy when the virus invades cells, inducing the cells to eliminate the virus. It is considered a broad-spectrum antiviral candidate substance capable of demonstrating efficacy regardless of the virus type or mutation.

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