The Ministry of Food and Drug Safety (MFDS, formerly the Korea Food and Drug Administration) has accepted South Korea-based Enzychem Lifesciences' Investigational New Drug (IND) application to start a phase two study of its lead therapeutic candidate, EC-18, in Preventing Acute Respiratory Distress Syndrome (ARDS) due to COVID-19, it was reported on Thursday.

The drug has been shown to pre-clinically control neutrophil infiltration, thereby modulating the inflammatory cytokine and chemokine signalling that has been implicated in these severe COVID-19 cases. It has also been shown to improve lung function and decrease inflammation and fibrosis, in multiple animal models of immune-mediated acute lung injury and also other inflammatory diseases, such as pneumonia.

The Phase two clinical trial is a multi-centre, randomised, double-blind placebo-controlled study to assess the safety and efficacy of the product in preventing ARDS due to COVID-19 pneumonia. The study will enrol 60 confirmed COVID-19 positive patients at Chungbuk University Hospital and various institutions in South Korea. Randomised patients will take EC-18 2000 mg or placebo daily for 14 days. Safety and tolerability will be evaluated on days 7 and 14. The primary endpoint of the study is the incidence of severe pneumonia or acute respiratory distress syndrome during a 14-day period and secondary endpoints in the study include cytokine level analysis and radiographic improvement of pneumonia.