Hyundai Bio's COVID-19 Treatment Phase 2 Clinical Trial Receives Positive Drug Evaluation from DSMB Experts

[Asia Economy Reporter Hyungsoo Park] Modern Bio, a drug delivery system developer, announced that its COVID-19 treatment candidate ‘CP-COV03,’ currently undergoing Phase 2 clinical trials, received positive evaluations from external experts during the interim assessment of Phase 2. The possibility of the world’s first universal antiviral drug has increased.

Modern Bio stated on the 25th that it received a ‘continue clinical trial’ recommendation after a positive evaluation from the Data Safety Monitoring Board (DSMB). The DSMB reviewed the results of the first round of Phase 2 clinical trials of CP-COV03 involving 36 participants.

The DSMB is composed for each clinical trial and consists of independent external experts who assess potential risks to participant safety. They recommend whether to continue or halt the trial. Since the DSMB evaluates not only the safety but also the efficacy of the drug, it can recommend stopping the trial to the sponsoring company and clinical institutions if the drug proves ineffective.

In its review, the DSMB judged that CP-COV03 showed positive results without significant side effects or adverse reactions in the first round of Phase 2 clinical trials and unanimously recommended continuing the trial. Modern Bio resumed the Phase 2 COVID-19 clinical trial of CP-COV03, which had been temporarily paused ahead of the DSMB review.

The DSMB’s positive evaluation of CP-COV03’s safety and other aspects in the interim Phase 2 assessment indicates an increased likelihood of clinical success for CP-COV03 against COVID-19. This also accelerates the progress of subsequent clinical trials.

A Modern Bio official said, "The DSMB’s recommendation raises expectations that CP-COV03, a safe universal antiviral drug, will be reborn through drug repurposing of ‘Niclosamide,’ which was first commercialized by Bayer in 1959 after more than 60 years."

He added, "Over the past 20 years, global research institutions have demonstrated excellent efficacy of Niclosamide against dozens of viral infectious diseases, including COVID-19, monkeypox, hepatitis, and AIDS, through ‘cell efficacy experiments.’ Due to its low bioavailability, CP-COV03 is the only case that has succeeded in proving safety and efficacy in animals and humans," he added.

Modern Bio succeeded in increasing the bioavailability of Niclosamide up to 43 times for the first time in the world by using advanced core technology related to drug delivery systems. Based on this, they developed ‘CP-COV03’ and demonstrated its safety and efficacy through animal experiments and Phase 1 clinical trials. CP-COV03 is a ‘cell-targeted’ antiviral drug that promotes autophagy in cells when the virus invades, inducing the cells to eliminate the virus. It is considered a universal antiviral candidate effective regardless of the virus type or mutation.

Modern Bio plans to expand the CP-COV03 pipeline from COVID-19 to viral diseases such as monkeypox, AIDS, and hepatitis based on its universal antiviral effects. The company explains that it aims to develop a broad-spectrum antiviral drug similar to penicillin, a representative broad-spectrum antibiotic.

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