Enzychem Lifesciences Corp. announced that the U.S. Food and Drug Administration has accepted its Investigational New Drug Application to evaluate its lead therapeutic candidate EC-18, in a Phase 2 clinical trial in patients with Acute Respiratory Disease Syndrome due to COVID-19 pneumonia. A Phase 2 study for EC-18 in Preventing ARDS due to novel coronavirus pneumonia is currently ongoing in South Korea. The US-based Phase 2 study is a multi-center, randomized, double-blind, placebo-controlled study to evaluate the safety and efficacy of EC-18 in preventing the progression of COVID-19 infection to severe pneumonia or ARDS. The study duration is 12 months from the FDA approval date. The study plans to enroll a total of 60 subjects in total, 30 patients in the EC-18 arm and the other 30 patients on the placebo arm. The dosing schedule will be 2000 mg QD (once daily), over a treatment period of 28 days. The primary endpoint of the Phase 2 study is proportion of patients alive and free of respiratory failure through at Day 28. Dr. Cameron Robert Wolfe is the lead scientific advisor to company’s COVID-19 program in the US. 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. EC-18 is the company's proprietary compound originally derived from Sika deer antler, which acts as Pattern Recognition Receptors (e.g., TLR4) endocytic trafficking accelerator contributing to swift removal of PAMPs/DAMPs. For acute respiratory distress syndrome associated with COVID-19, dysregulation of the TLRs signaling pathway is reported to be relevant. With this unique mechanism of action, the company is developing EC-18 for indications including chemoradiation induced oral mucositis, chemotherapy induced neutropenia and acute radiation syndrome.