CrystalGenomics Receives Approval for Phase 2 Clinical Trial of COVID-19 Treatment

[Asia Economy Reporter Oh Ju-yeon] CrystalGenomics announced on the 2nd that its clinical trial application (IND) for the Phase 2 clinical trial of Camostat, a serine protease inhibitor, as a treatment for the novel coronavirus infection (COVID-19), has been approved by the Ministry of Food and Drug Safety.

This clinical trial will evaluate the efficacy and safety of Camostat in 100 patients with mild to moderate COVID-19 who have been confirmed infected and admitted to hospitals or residential treatment centers. Group A (50 patients) will receive oral Camostat for 7 days along with the best supportive care, while Group B (50 patients) will receive a placebo orally for 7 days along with the best supportive care.

Professor Kim Yang-soo of Seoul Asan Medical Center, a leading expert in infectious diseases in Korea, will lead this clinical trial as the principal investigator.

The background of this clinical trial is based on a study published in April by the Leibniz Primate Research Institute in G?ttingen, Germany, in the journal Cell, which reported that inhibition of protease (TMPRSS2) activity by Camostat effectively blocks the entry of the COVID-19 virus into cells, thereby suppressing intracellular infection.

According to the experimental results, the 50% inhibitory concentration of Camostat for cell infection is below 1 uM (micromolar), which is tens to hundreds of times lower than that of antiviral candidates such as Remdesivir and Hydroxychloroquine.

Additionally, a 2015 mouse animal study published in the National Institutes of Health journal showed that when Camostat was administered after infection with a lethal dose of SARS-CoV, the survival rate increased by approximately 60% compared to the control group.

A CrystalGenomics official stated, "SARS and COVID-19 share about 94.6% similarity in amino acid sequences and are known to share the same cellular infection mechanism. Therefore, if Camostat is effective against SARS, the same effect can be expected for COVID-19." They added, "If the efficacy of Camostat against COVID-19 is confirmed through this clinical trial, it can be rapidly developed as a treatment and significantly contribute to hastening the end of the COVID-19 pandemic."

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