Enzychem Lifesciences announced that the Ministry of Food and Drug Safety (MFDS, formerly the Korea Food and Drug Administration), has accepted its Investigational NewDrug (IND) application to initiate a Phase 2 study for its lead therapeutic candidate, EC-18 in Preventing Acute Respiratory Distress Syndrome (ARDS) due to novel coronavirus pneumonia. EC-18 has been shown pre-clinically to control neutrophil infiltration, thereby modulating the inflammatory cytokine and chemokine signaling that has been implicated in these severe COVID-19 cases. EC-18 has also been shown to improve lung function, as well as to reduce inflammation and fibrosis, in multiple animal models of immune mediated acute lung injury and also other inflammatory diseases, such as pneumonia. The Phase 2 clinical trial is a multi-center, randomized, double-blind placebo-controlled study to evaluate the safety and efficacy of EC-18 in preventing acute respiratory distress syndrome (ARDS) due to novel coronavirus pneumonia. The study will enroll 60 confirmed COVID-19 positive patients at Chungbuk University Hospital and a number of institutions in South Korea. Randomized patients will take EC-18 2000 mg or placebo daily for 14 days (30 patients on active arm, 30 patients on placebo). Safety and tolerability will be assessed on Days 7 and 14. The primary endpoint of the study is the incidence of severe pneumonia or ARDS during a 14-day period and secondary endpoints in the study include cytokine level analysis and radiographic improvement of pneumonia. In addition, EC-18 is in Phase 2 clinical trials for chemoradiation-induced oral mucositis (CRIOM) and chemotherapy-induced neutropenia (CIN) the U.S and South Korea, as well as in animal rule studies in acute radiation syndrome (ARS). In clinical studies to date, EC-18 is observed to be generally safe and well tolerated with no drug related serious adverse events, consistent with Phase 1 study results in healthy volunteers.