Engchem Life Sciences Receives MFDS IND Approval for Phase 2 Clinical Trial of COVID-19 Treatment

[Asia Economy Reporter Hyungsoo Park] Engchem Life Sciences has received approval for the clinical phase 2 trial plan (IND) for its novel coronavirus disease (COVID-19) treatment.

Engchem Life Sciences announced on the 13th that it received approval from the Ministry of Food and Drug Safety for the clinical phase 2 trial plan (IND) of its COVID-19 treatment (EC-18).

An Engchem Life Sciences official explained, "We expect EC-18 to safely and effectively control the cytokine storm, the number one complication causing death in COVID-19 patients," adding, "We believe the Ministry of Food and Drug Safety promptly approved the IND for the COVID-19 treatment."

It is also analyzed that the sufficient number of international papers on mechanisms of action including acute lung injury, sepsis, pneumonia, and chronic obstructive pulmonary disease (COPD), as well as various experimental data proving efficacy, were grounds for receiving IND approval in a short period.

Following the approval of the clinical phase 2 IND for the COVID-19 treatment by the Ministry of Food and Drug Safety, Engchem Life Sciences plans to expedite the clinical phase 2 IND with the U.S. Food and Drug Administration (FDA) in the United States, where it has filed a patent for the COVID-19 treatment.

Engchem Life Sciences will begin clinical trials to prove the efficacy of EC-18 with multiple clinical institutions centered on Chungbuk National University Hospital, a national hospital. The clinical trial will be conducted on 60 patients and designed as a double-blind placebo-controlled study to enhance the value of efficacy data.

Professor Myunghwan Kim of Seoul Asan Medical Center stated, "EC-18 is expected to reduce the mortality rate of COVID-19 by regulating innate immune function and preventing cytokine storms," adding, "The rapid inflammation resolution ability of EC-18 has been proven effective in animal experiments on acute lung injury and abdominal sepsis."

He further added, "Most COVID-19 treatments currently under development are antiviral agents and have limitations in suppressing cytokine storms."

Lee Doyoung, Director of Engchem Life Sciences Gwanggyo Research Center, said, "We are confident that the efficacy and safety of EC-18 for COVID-19 patients will be recognized through clinical trials," and explained, "If efficacy is confirmed during the clinical research period through rapid clinical progress, we plan to provide data not only to authorities and research institutions but also to multinational pharmaceutical companies capable of collaboration."

Engchem Life Sciences is a new drug development company established in 1999. It holds the original technology of the new drug substance 'EC-18,' which is noted as an inflammation resolution promoter and neutrophil migration regulator. EC-18 is currently undergoing phase 2 clinical trials for indications including chemotherapy and radiation therapy-induced oral mucositis (CRIOM), chemotherapy-induced neutropenia (CIN), and acute radiation syndrome (ARS).