Ildong Pharmaceutical Group’s ‘iLeadBMS’ Presents Non-Clinical Results of its Novel NASH Drug Candidate at the AASLD 

DONGTAN, KOREA, November 9, 2022

Ildong Pharmaceutical Group announced that iLeadBMS, an affiliate company that specializes in the R&D of small molecule new drugs, presented0 non-clinical research results related to the Non-Alcoholic Steatohepatitis (NASH) treatment candidate 'ID119031166M' at the American Association for the Study of the Liver Diseases (AASLD).

AASLD is the world's largest scientific congress in the field of liver research and holds an annual academic conference to share the research results and the latest knowledge on the diagnosis and treatment of liver diseases. This year’s event, ‘AASLD 2022’, was held in Washington D.C., USA from the 4th to the 8th.

ID119031166M is a drug with an FXR agonist mechanism as it binds to the Farnesoid X Receptor (FXR) and activates the receptor. FXR agonists are known to be involved in the liver lipid and sugar metabolism, bile acid production and excretion, and inflammatory response.
At this conference, iLeadBMS presented the results of in vitro studies, non-clinical pharmacokinetics (PK) and pharmacodynamics (PD) studies, and NASH efficacy studies related to ID119031166M, through a poster presentation.

According to the Company, in vitro studies showed that ID119031166M had excellent drug efficacy and target selectivity. And it was confirmed that the evaluation indicators related to the pharmacokinetics and pharmacodynamics were increased proportionally to the drug dosage in a multiple dose escalation test involving administration of the test article once a day for 2 weeks. Additionally, in a NASH animal model using rodents where ID119031166M was administered orally once a day, efficacy in NASH and safety, were observed.

A Company Spokesperson said, “In the case of NASH, an appropriate treatment has not yet been developed, and therefore, this is an area with great market potential,” and added, “We have great expectations as we have confirmed the potential and competitiveness of ID119031166M as being the “Best-in-Class” drug.

Previously, iLeadBMS collaborated with Ildong Pharmaceutical to conduct non-clinical research and develop clinical trial material necessary for obtaining the FDA's approval for the Investigational New Drug (IND) for ID119031166M.

Ildong Pharmaceutical obtained approval for a phase 1 clinical trial from the FDA last July and is currently conducting a phase 1 clinical trial in the United States to evaluate the safety, tolerability, and pharmacokinetics of ID119031166M in healthy adults.