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Enzychem Lifesciences has submitted an investigational new drug application (IND) to the US Food and Drug Administration to begin a Phase II clinical trial assessing EC-18 as a therapeutic agent for the treatment of acute respiratory disease syndrome (ARDS) due to Covid-19 pneumonia.
The trial is a multi-centered, randomised, placebo-controlled study designed to assess the safety and efficacy of EC-18 in preventing the progression of the Covid-19 infection to severe pneumonia.
The study lasts for a period of 12 months from the day of receiving the FDA approval.
According to Enzychem Lifesciences, the study will involve the participation of a total of 60 subjects, with 30 patients in the EC-18 arm and the remaining 30 patients on the placebo arm.
Under the study, patients will be administered to receive 2,000mg once daily for a period of 28 days.
Enzychem Lifesciences chairman and CEO Ki Young Sohn said: “Enzychem’s primary focus is rapidly determining the safety and efficacy of EC-18 as a potential treatment for ARDS prevention due to Covid-19 pneumonia.
“We are preparing plans for initiating the Phase II study upon the IND becoming active by the US FDA and look forward to advancing EC-18 as a potential new treatment option for patients with a confirmed Covid-19, based on EC-18’s unique mechanism of action.”
EC-18 has a mechanism to remove pathogens or viruses by enabling immune cells to engulf the virus or bacteria and remove them in a short period of time. It eliminates pathogens by capturing the virus or bacteria and binding it to the receptor.
Furthermore, EC-18 is capable of reducing the gathering of inflammatory cells due to rapid removal of damage associated molecular pattern (DAMPs) that accumulate when cells are damaged by radiation.
It also prevents tissue damage produced by the sudden activity inflammatory cells.
The compound is derived from Sika deer antler and contributes to the swift removal of PAMPs/DAMPs.
In March this year, Enzychem Lifesciences said it was set to advance a domestic clinical trial of EC-18 in South Korea.