Enzychem Lifesciences announced that the US Food and Drug Administration (FDA) has accepted its Investigational New Drug Application (IND) to evaluate its lead therapeutic candidate EC-18, in a phase 2 clinical trial in patients with acute respiratory disease syndrome (ARDS) 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, associate professor of medicine at Duke University School of Medicine, and an internationally renowned specialist in infectious diseases, is the lead scientific advisor to Enzychem’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.
“We are extremely pleased with the FDA’s decision and believe there is strong scientific rationale for the development of EC-18 to treat ARDS in COVID-19 patients. This IND approval is an important first step in Enzychem’s evolution into becoming a global biopharmaceutical leader. We look forward to advancing EC-18 as a potential new treatment option for patients with confirmed COVID-19, based on EC-18’s unique mechanism of action,” said Ki Young Sohn, CEO and chairman of Enzychem Lifesciences.
EC-18 is the company's proprietary compound originally derived from Sika deer antler, which acts as Pattern Recognition Receptors (PRR) (eg, 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 (CRIOM), chemotherapy induced neutropenia (CIN) and acute radiation syndrome (ARS).