Korean health regulator gives green light to domestic COVID-19 clinical trial
Korean health regulator gives green light to domestic COVID-19 clinical trial
  • Shin Hyoung-ju
  • 승인 2020.03.03 17:36
  • 댓글 0
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ImmuneMed, SNUH petition to use HzVSv13 injection as COVID-19 treatment
Gilead’s remdesivir, Toyoma Chemical’s Avigan to soon undergo domestic clinical trials

While domestic and overseas anti-viral drugs are being researched to treat the novel coronavirus (COVID-19), several local pharmaceutical firms have also launched their clinical trials in the country.

The Ministry of Food and Drug Safety (MFDS) said that it approved a clinical trial from ImmuneMed and Seoul National University Hospital (SNUH) on Feb 21st.

The two institutions applied to use the experimental 'HzVSFv13 injection' in a clinical trial to treat COVID-19.

Investigators had previously in 2018 conducted a phase 1 clinical trial on healthy males to evaluate the safety, tolerability and pharmacokinetics of the HzVSFv13 intravenous injection.

Currently, investigators have completed the phase 1 trial and are getting ready to start the phase 2 clinical trial.

A SNUH medical team that led the phase 1 trial will conduct the clinical trial for COVID-19.

Meanwhile, Gilead's remdesivir, which was developed as an Ebola anti-viral therapy and currently a candidate for treating COVID-19, is also getting prepped for domestic clinical trials.

Gilead has not yet submitted a plan of the clinical trial to MFDS, but industry insiders say that it will be submitted soon.

Also, the national health authorities are planning to authorize the importation and clinical use of Avigan (ingredient favipiravir), which is used as a treatment for COVID-19 in Japan.

Avigan is a new influenza drug developed by Toyama Chemical, and clinical trials have been conducted to expand indications for severe febrile thrombocytopenia syndrome (SFTS), among others.



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