Enzychem Lifesciences Granted US Patent for Acute Radiation Syndrome (ARS)

[Asia Economy Reporter Lee Gwan-joo] Engchem Life Sciences announced on the 16th that it received a patent grant from the United States Patent and Trademark Office on the 9th for a treatment for Acute Radiation Syndrome (ARS) using EC-18.

With this patent grant decision, Engchem Life Sciences' global licensing of EC-18 is expected to gain momentum. Professor David Gordina, a member of Engchem Life Sciences' Scientific Advisory Board (SAB), emphasized the potential of EC-18 as a drug addressing the unmet medical needs for Acute Radiation Syndrome.

Acute Radiation Syndrome is a rare disease that occurs when the human body is exposed to a lethal dose of radiation due to nuclear attacks or nuclear power plant disasters. It causes fatal damage to the hematopoietic system, digestive system, and central nervous system, and is known to threaten life by causing bacterial infections and sepsis due to immune deficiency.

Engchem Life Sciences' treatment for Acute Radiation Syndrome was designated as an orphan drug by the U.S. FDA in December 2018. It is granted a seven-year exclusive license during development and receives support for R&D funding and tax incentives. Additionally, it is currently the only oral treatment candidate for Acute Radiation Syndrome eligible for conditional approval upon completion of Phase 2 clinical trials under the 'FDA Animal Rule.'

Subsequently, in May 2019, the Phase 2 IND was approved, and in the same year, it was selected for a key government funding program by the U.S. National Institute of Allergy and Infectious Diseases. Together with Arizona State University and private companies SRI and Battelle, Engchem Life Sciences is conducting new drug development projects such as the 'Chemical Weapons Response Research Program' (CCRP) and the 'Radiological and Nuclear Countermeasures Program' (RNCP).

An Engchem Life Sciences official stated, "Because Phase 2 clinical trials for Acute Radiation Syndrome require exposure to lethal levels of radiation in humans, the clinical trials are conducted on non-human primates instead, in accordance with the 'FDA Animal Rule.' Upon completion of these trials, it is recognized as having completed Phase 2 clinical trials." He added, "This patent is expected to be applicable not only to treatments for Acute Radiation Syndrome but also to treatments for space radiation."