Biotherapeutics company Enzychem Lifesciences said on Thursday that its Investigational New Drug (IND) application to launch a Phase 2 study of EC-18 in preventing acute respiratory distress syndrome (ARDS) due to novel coronavirus pneumonia has been accepted by Korea's Ministry of Food and Drug Safety (MFDS).
The company's lead therapeutic candidate EC-18 has been shown pre-clinically to 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, as well as reduce inflammation and fibrosis, in multiple animal models of immune-mediated acute lung injury and other inflammatory diseases.
Under the multi-centre, randomised, double-blind placebo-controlled Phase 2 clinical trial, the company will evaluate the safety and efficacy of EC-18 in preventing ARDS due to novel coronavirus pneumonia in 60 confirmed COVID-19 positive patients at Chungbuk University Hospital and a number of institutions in South Korea. Patients will take EC-18 2000 mg or placebo daily for 14 days. The primary endpoint of the study is the incidence of severe pneumonia or ARDS during a 14-day period.
Concurrently, EC-18 is in Phase 2 clinical trials for chemoradiation-induced oral mucositis (CRIOM) and chemotherapy-induced neutropenia (CIN) the US and South Korea, as well as in animal rule studies in acute radiation syndrome (ARS).
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