South Korea’s Enzychem Lifesciences announced the U.S. Food and Drug Administration (FDA) has approved its investigational new drug application (IND) to commence a phase 2 clinical trial assessing novel compound EC-18 as a therapeutic agent for the treatment of acute respiratory symptoms in COVID-19 patients.

The Kosdaq-listed company said it expects the phase 2 study to be completed in the first half of next year because the U.S. has a large number of COVID-19 patients with a high prevalence of severe cases, which means patients can be recruited more quickly than other countries.

Enzychem plans to apply for emergency authorization for the drug with the FDA depending on the study result.

Shares of Enzychem fell 3 percent to 153,500 won on profit-taking after going as high as 184,900 won.

The company already named Dr. Cameron Robert Wolfe, associate professor of medicine at Duke University School of Medicine, to lead the study. The internationally renowned specialist in infectious diseases is currently an investigator in a Remdesivir study in severe COVID-19 patients.

The phase 2 study is a multicenter, randomized, double blind and placebo controlled clinical trial in 60 patients with pneumonia due to the virus. The patients will be randomized to either EC-18 plus standard of care or placebo plus standard of care in a 1:1 randomization scheme to evaluate the efficacy and safety of EC-18.

By Pulse

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