Policy & Regulation
Enzychem Lifesciences Wins FDA Acceptance of Phase 2 Study of EC-18 in Preventing Acute Respiratory Distress Syndrome due to COVID-19 Pneumonia
13 August 2020 - - The US Food and Drug Administration has accepted US-based Enzychem Lifesciences' (KOSDAQ: 183490) 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, the company said.

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.

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 (CRIOM), chemotherapy induced neutropenia and acute radiation syndrome.

Enzychem Lifesciences Corp. (KOSDAQ: 183490) is a global pharmaceutical company focused on developing oral small molecule therapies for patients with significant unmet needs in oncology, inflammatory, and severe respiratory diseases.

Founded in 1999, the company's lead candidate EC-18 is currently in a Phase 2 clinical trials for oral mucositis and chemotherapy-induced neutropenia.

The company is also developing EC-18 in metabolic disorders such as nonalcoholic steatohepatitis, in combination cancer therapy with immune checkpoint inhibitors, and in severe respiratory diseases as a potential therapy for COVID-19. EC-18, or PLAG, is a fully synthesized substance, derived from an active ingredient in Sika deer antlers.