ImmuneMed, a South Korean biotech firm, will soon launch clinical trials of its investigational coronavirus treatment outside Korea, the company chief executive Kim Yoon-won told Maeil Business Newspaper on Wednesday.

He has been invited by two Southeast Asian leaders and one European healthcare policymaker to carry out human tests in their territories.

ImmuneMed has developed its virus suppressing drug HzVSF as a therapy to treat patients infected with COVID-19 after efficacy was demonstrated in five severe patients hospitalized at Seoul National University Hospital, Chungnam National University Hospital, and Yeungnam University Medical Center. The company is unlisted.

The new antibody drug, an injection-type of the company’s virus suppressing factor (VSF), was proven effective in a phase 1 study of patients with hepatitis B and influenza infection.

But in a preclinical cell-based study, the drug failed to show a statistically significant difference in the treatment of COVID-19 unlike hepatitis B virus. Without preclinical evidence, the company is not allowed to go further into a full-scale human test under the protocol set by the country’s health authorities.

Kim said the discrepancy between preclinical and clinical data suggests viral suppression happens through intercellular effects in the body, not within specific cells, adding it is a pity that further clinical trials are suspended due to the cell test results although HzVSF has improved symptoms in severe COVID-19 cases.

Kim said that he will allow HzVSF to be tested for COVID-19 patients in Korea at the request of individual hospitals, while commercial development will be pushed outside Korea upon discussion with overseas partners over clinical and development conditions.

HzVSF is the only approved drug for COVID-19 treatment, which is limited to investigational use in Korea. When infected with virus, VSF activates the body`s natural healing process. ImmuneMed first discovered VSF in rats, and later in the human body and named it HzVSF. ImmuneMed said it repeatedly confirmed that COVID-19 symptoms are improved when HzVSF amplified by 1,000 times is administered.

By Kim Byung-ho and Minu Kim

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