Enzychem Files IND for Phase 2 Study of EC-18 in Preventing ARDS Due to COVID-19 Pneumonia

Enzychem Lifesciences has filed an Investigational New Drug Application (IND) to the US Food and Drug Administration (FDA) for a Phase 2 clinical trial of EC-18 as a preventative therapeutic against 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 probability of progression of mild pneumonia patients to severe pneumonia or ARDS within 28 days.

Dr. Cameron Robert Wolfe, associate professor of medicine at Duke University School of Medicine, an internationally renowned specialist in infectious diseases, will lead Enzychem's Phase 2 US study.

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.

"Enzychem's primary focus is rapidly determining the safety and efficacy of EC-18 as a potential treatment for ARDS prevention due to COVID-19 pneumonia. We are preparing plans for initiating the Phase 2 study upon the IND becoming active by the U.S. FDA and look forward to advancing EC-18 as a potential new treatment option for patients with a 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) 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).