Enzychem Lifesciences said that the Ministry of Food and Drug Safety has approved its investigational new drug (IND) application to conduct phase 2 clinical trials of EC-18, a treatment candidate for Covid-19.
The company said it believes that ministry quickly approved its IND for EC-18, as the treatment has proved that it can safely and effectively treat cytokine storm syndrome, which is the number one complication that can lead to death among Covid-19 infected patients.
Enzychem plans to speed up efforts to make a similar application to the U.S. Food and Drug Administration.
The company will begin clinical trials to demonstrate the efficacy of EC-18 with several clinical institutions, including Chungbuk National University Hospital. The trial on 60 patients will be a double-blinded placebo-controlled trial to increase the value of efficacy data.
“EC-18 is expected to reduce Covid-19 mortality by regulating innate immune function to prevent cytokine storms,” Professor Kim Myung-hwan at Asan Medical Center said. “EC-18 as an immunomodulator is likely to expand indications greatly by applying it in combination with other antiviral agents for the treatment of Covid-19 and sepsis caused by bacterial infections.”
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