[Asia Economy Reporter Lee Gwan-joo] Ildong Pharmaceutical Group announced on the 9th that its synthetic new drug research and development affiliate, iLeadBMS, revealed the preclinical research results of the non-alcoholic steatohepatitis (NASH) treatment candidate 'ID119031166M' at the American Association for the Study of Liver Diseases (AASLD) conference.
AASLD is the world's largest academic society researching liver diseases, hosting an annual conference to share research achievements and the latest insights on the diagnosis and treatment of liver diseases. This year's event was held from December 4 to 8 (local time) in Washington, USA.
ID119031166M is a drug with an FXR agonist mechanism that binds to and activates the Farnesoid X receptor (FXR). FXR agonists are known to be involved in liver lipid and glucose metabolism, bile acid synthesis and excretion, and inflammatory responses.
At this conference, iLeadBMS introduced in a poster presentation the in vitro studies, preclinical pharmacokinetics (PK) and pharmacodynamics (PD) studies, and NASH efficacy studies related to ID119031166M.
According to the company, in vitro studies showed excellent drug potency and target selectivity of ID119031166M, and a multiple ascending dose study with once-daily administration for two weeks confirmed dose-proportional increases in related indicators from pharmacokinetic and pharmacodynamic perspectives. Additionally, in a NASH animal model study using rodents, once-daily oral administration demonstrated efficacy and safety related to NASH treatment.
Previously, iLeadBMS collaborated with Ildong Pharmaceutical to conduct preclinical studies and develop clinical reagents to obtain the Investigational New Drug (IND) approval from the U.S. Food and Drug Administration (FDA) for ID119031166M.
In July, Ildong Pharmaceutical obtained FDA IND approval for Phase 1 clinical trials and is currently conducting clinical trials in the United States to evaluate the safety, tolerability, and pharmacokinetics of ID119031166M in healthy adults.
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