Policy & Regulation
Enzychem to begin Phase 2 study of EC-18 in the US to prevent ARDS due to COVID-19 pneumonia
14 August 2020 -

Pharmaceutical company Enzychem Lifesciences (KOSDAQ: 183490) said on Thursday that it has successfully submitted its Investigational New Drug Application (IND) with the US Food and Drug Administration (FDA) 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.

Currently, a Phase 2 study for EC-18 in preventing ARDS due to novel coronavirus pneumonia is ongoing in South Korea, said the company.

Under the multi-centre, randomized, double-blind, placebo-controlled Phase 2 study, the company will 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. 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.

Enzychem added that the dosing schedule will be 2000mg 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, is the lead scientific advisor to Enzychem's COVID-19 programme in the US.

EC-18 is the company's proprietary compound derived from Sika deer antler, which acts as Pattern Recognition Receptors (PRR) (TLR4) endocytic trafficking accelerator contributing to swift removal of PAMPs/DAMPs. EC-18 has shown pre-clinically to control neutrophil infiltration, modulating the inflammatory cytokine and chemokine signaling that has been implicated in these severe COVID-19 cases.