The US Food and Drug Administration (FDA) has accepted Enzychem Lifesciences’ investigational new drug (IND) application to assess EC-18 in a Phase II clinical trial in Covid-19 patients.
The trial will enrol patients with acute respiratory disease syndrome (ARDS). A Phase II trial of EC-18 to prevent Covid-19-related ARDS is ongoing in South Korea.
During the multi-centre, randomised, double-blind, placebo-controlled Phase II trial in the US, EC-18’s safety and efficacy will be investigated for preventing the progression of Covid-19 to severe pneumonia or ARDS.
From the FDA approval date, the trial will take place for 12 months. It will recruit a total of 60 participants across the EC-18 and placebo groups.
The trial’s primary endpoint is the proportion of patients alive and free of respiratory failure at day 28.
EC-18 was found to regulate neutrophil infiltration in preclinical studies, modulating the inflammatory cytokine and chemokine signalling found in severe Covid-19 patients.
The drug candidate was also observed to improve lung function, mitigate inflammation and fibrosis in various animal models of inflammatory diseases, including immune-mediated acute lung injury and pneumonia.
Enzychem Lifesciences CEO and chairman Ki Young Sohn said: “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.
“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.”
EC-18 is obtained from Sika deer antler, which is known to function as Pattern Recognition Receptors (PRR) endocytic trafficking accelerator.
Dysregulation of the TLRs signaling pathway is involved in Covid-19-related ARDS.
EC-18’s mechanism is expected to help potentially treat chemoradiation induced oral mucositis (CRIOM), chemotherapy induced neutropenia (CIN) and acute radiation syndrome (ARS).