LG Chem Receives US Approval for Phase 1 Clinical Trial of NASH Treatment

[Asia Economy Reporter Cho Hyun-ui] LG Chem announced on the 2nd that it has received approval from the U.S. Food and Drug Administration (FDA) for the Phase 1 clinical trial of its non-alcoholic steatohepatitis (NASH) treatment candidate ‘TT-01025’.

With this approval, LG Chem will evaluate safety and pharmacokinetics in healthy adults locally.

TT-01025 is a NASH treatment candidate that LG Chem acquired in August from the Chinese biotech company 'Transthera Biosciences' with the goal of global exclusive development and commercialization. It has a mechanism that inhibits the expression of the 'VAP-1' protein, which is known to influence inflammation in the liver.

LG Chem stated, "Preclinical results showed a very high selective action on VAP-1," adding, "We expect the development of a safe and effective treatment without the ‘drug-drug interactions’ that caused the discontinuation of clinical trials for existing candidates with the same mechanism."

NASH is an untapped market with no existing treatments due to the high difficulty of new drug development. The number of patients is expected to continuously increase due to the rising population of obesity, a major cause of the disease.

Manfred Staff, Head of LG Chem Global Innovation Center, explained, “NASH is a silent disease that shows no special symptoms and, if not treated in time, can lead to cirrhosis requiring liver transplantation.”

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