The acceptance of IND will allow Enzychem to assess EC-18 in a phase 2 clinical study in patients with ARDS due to Covid-19.
The EC-18 is originally obtained from Sika deer antler that serves as pattern recognition receptors (PRR) endocytic trafficking accelerator to remove PAMPs/DAMPs.
A phase 2 study for EC-18 in preventing ARDS due to novel coronavirus pneumonia is presently ongoing in South Korea, said the company.
The US-based multi-centre, randomised, double-blind and a placebo-controlled trial will assess the safety and efficacy of EC-18 in avoiding the progression of Covid-19 infection to severe pneumonia or ARDS.
Enzychem intends to recruit 60 subjects in a one-year duration study, of which 30 patients in the EC-18 arm and the other 30 patients on the placebo arm.
The 2000 mg QD (once daily) is the dosing schedule in the study over a treatment period of 28 days.
According to the company, the primary endpoint of the trial is the proportion of patients alive and free of respiratory failure through at day 28.
Duke University School of Medicine medicine associate professor Dr Cameron Robert Wolfe is the main scientific advisor to Enzychem’s Covid-19 programme in the US.
Enzychem stated that the EC-18 has been demonstrated pre-clinically to control neutrophil infiltration, thereby regulating the inflammatory cytokine and chemokine signalling that has been involved in these severe Covid-19 cases.
It is also said to be demonstrated to enhance lung function and reduce inflammation and fibrosis, in multiple animal models of immune-mediated acute lung injury and also other inflammatory diseases such as pneumonia.
Enzychem Lifesciences CEO and chairman Ki Young Sohn said: “We are extremely pleased with the FDA’s decision and believe there is a strong scientific rationale for the development of EC-18 to treat ARDS in Covid-19 patients.
“This IND approval is an important first step in Enzychem’s evolution into becoming a global biopharmaceutical leader. 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.”
Recently, SAB Biotherapeutics has dosed the first participant of a phase 1 study of SAB-185, its therapeutic candidate for Covid-19, in healthy volunteers.