S. Korean bio firm wins FDA approval for clinical trials of coronavirus treatment
SEOUL, Aug. 7 (Yonhap) -- South Korean bio venture firm Enzychem Lifesciences Corp. said Friday that it has won approval from the U.S. health agency to conduct clinical trials for its treatment candidate for the novel coronavirus.
The U.S. Food and Drug Administration authorized Enzychem Lifesciences to conduct a phase two clinical study assessing the candidate, dubbed "EC-18," as a preventive therapeutic against Acute Respiratory Disease Syndrome (ARDS) due to COVID-19 pneumonia.
A phase two clinical study for EC-18 in preventing ARDS due to novel coronavirus pneumonia is ongoing in South Korea, the firm said.
The trial is designed to assess the safety and efficacy of EC-18 in preventing the progression of COVID-19 infection to severe pneumonia, the bio firm said.
The study will involve the participation of a total of 60 subjects, with 30 patients administered with the treatment candidate and the remaining 30 patients on the placebo, Enzychem Lifesciences said.
khj@yna.co.kr
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