Enzychem Lifesciences announced the Ministry of Food and Drug Safety (MFDS, formerly the Korea Food and Drug Administration), has accepted its Investigational New Drug (IND) application to initiate a Phase 2 study for its lead therapeutic candidate, EC-18 in Preventing Acute Respiratory Distress Syndrome (ARDS) due to novel coronavirus pneumonia.

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.

"Many COVID-19 patients with severe disease experience serious, sometimes fatal, respiratory complications caused by an excessive inflammatory response in the lung, called acute respiratory distress syndrome (ARDS) due to novel coronavirus pneumonia," said Ki Young Sohn, Chief Executive Officer of Enzychem Lifesciences. "The inflammatory lung injury related to COVID-19 may be similar to that of severe respiratory diseases, such as acute lung injury (ALI) and sepsis, for which we have conducted research and EC-18 has shown good activity."

"We believe there is strong scientific rationale for the development of EC-18 to treat COVID-19 patients," said Sohn. "EC-18 acts as PRR endocytic trafficking accelerator (PETA), and facilitates the removal of pathogens and danger signals by accelerating the endocytic trafficking of pattern recognition receptors (PRRs), contributing to faster resolution of inflammation and an earlier return to homeostasis. Through this PETA mechanism, EC-18 can be an effective therapeutic drug for treating inflammatory diseases such as COVID-19, cancer, nonalcoholic steatohepatitis (NASH) and chemoradiation therapy-induced oral mucositis. By targeting the inflammatory pathway and innate immune response, we believe that EC-18'smechanism of action has substantial overlap with this disease pathology and presents a compelling opportunity to potentially treat this subset of COVID-19 patients for which there are no approved therapies. We look forward to urgently implementing and advancing this important study as we seek to play a significant role in the global battle against COVID-19."

The Phase 2 clinical trial is a multi-center, randomized, double-blind placebo-controlled study to evaluate the safety and efficacy of EC-18 in preventing acute respiratory distress syndrome (ARDS) due to novel coronavirus pneumonia. The study will enroll 60 confirmed COVID-19 positive patients at Chungbuk University Hospital and a number of institutions in South Korea. Randomized patients will take EC-18 2000 mg or placebo daily for 14 days (30 patients on active arm, 30 patients on placebo). Safety and tolerability will be assessed on Days 7 and 14. The primary endpoint of the study is the incidence of severe pneumonia or ARDS during a 14-day period and secondary endpoints in the study include cytokine level analysis and radiographic improvement of pneumonia.  

In addition, EC-18 is in Phase 2 clinical trials for chemoradiation-induced oral mucositis (CRIOM) and chemotherapy-induced neutropenia (CIN) the U.S and South Korea, as well as in animal rule studies in acute radiation syndrome (ARS). In clinical studies to date, EC-18 is observed to be generally safe and well tolerated with no drug-related serious adverse events, consistent with Phase 1 study results in healthy volunteers.