Engchem Life Sciences Receives IND Approval for Korea's First US FDA Phase 2 Clinical Trial of COVID-19 Treatment
Remdesivir Phase 3 Lead 'Duke Univ. Prof. Wolf' to Lead EC-18 COVID-19 Trial
High US COVID-19 Cases Favor Patient Recruitment... Early Trial Completion Expected
[Asia Economy Reporter Hyungsoo Park] Engchem Life Sciences' stock price is on the rise. On the 6th (U.S. local time), it was reported that the company became the first in Korea to receive approval from the U.S. Food and Drug Administration (FDA) for the clinical phase 2 trial plan (IND) of the new drug substance 'EC-18' as a COVID-19 treatment, which appears to have influenced the stock price.
As of 9:08 a.m. on the 7th, Engchem Life Sciences is trading at 171,000 KRW, up 8.1% from the previous day.
Engchem Life Sciences cautiously forecasts that since the U.S. has significantly more COVID-19 patients and a higher proportion of severe cases than Korea, it is advantageous for recruiting clinical trial patients, and the phase 2 clinical trial could be completed as early as the first half of next year. Depending on the clinical results, Engchem Life Sciences also plans to apply for Emergency Use Authorization (EUA) from the U.S. FDA to prioritize administration of the EC-18 COVID-19 treatment.
Engchem Life Sciences appointed Professor Wolf from Duke University, known as the lead for the remdesivir phase 3 clinical trial, as the head of the phase 2 clinical trial. They added that a 'COVID-19 Global Clinical Team' composed of experts in various fields is operating to expedite the phase 2 trial.
Engchem Life Sciences analyzes that the U.S. FDA swiftly approved the IND for the phase 2 clinical trial of the new drug substance 'EC-18' because it focused on its mechanism of action that effectively controls the 'cytokine storm,' the leading cause of death in COVID-19.
The FDA phase 2 trial will be conducted as a multicenter, randomized, double-blind, placebo-controlled study involving 60 patients with COVID-19 infectious pneumonia. Thirty patients will receive 'EC-18' along with standard treatment, while the others will receive a placebo and standard treatment. The efficacy and safety will be evaluated to determine to what extent 'EC-18' can prevent progression from mild pneumonia to severe pneumonia and acute respiratory distress syndrome.
Engchem Life Sciences' 'EC-18' is a new drug substance whose anti-COVID-19 mechanism has been validated through global clinical trials and numerous internationally authoritative research papers. It promotes intracellular recycling of pattern recognition receptors (PRR, TLRs) to effectively treat inflammatory diseases such as cytokine storms caused by COVID-19. Currently, global phase 2 clinical trials are underway in the U.S. and Korea for treatments of 'oral mucositis,' 'neutropenia,' and 'acute radiation syndrome.'
Son Ki-young, CEO of Engchem Life Sciences, said, "Receiving FDA approval for the phase 2 IND is a recognition that 'EC-18' is an excellent anti-COVID-19 substance validated by global clinical trials and numerous authoritative papers." He added, "We will fully commit to developing a powerful EC-18 treatment to end COVID-19 by urgently deploying the 'COVID-19 Global Clinical Team' led by Duke University’s Professor Wolf to the phase 2 trial."
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