LG Chem‘s non-alcoholic steatohepatitis treatment pipeline TT-01025 has been approved to carry out a clinical phase 1 trial by the US Food and Drug Administration, LG Chem announced Wednesday.

The phase 1 trial will be conducted by PPD’s clinical research unit in Las Vegas, with LG Chem‘s Manfred Stapff as the lead researcher.

TT-01025 is a pipeline LG Chem licensed in from Chinese biotech TransThera Biosciences in August. LG Chem has exclusive rights to develop and commercialize the drug in countries other than China and Japan.

TT-01025 can suppress VAP-1 protein, which is known to have close correlation with progression in liver inflammation.

In pre-clinical animal trials, TT-01025 has shown high targeted impact on VAP-1, as well as not interacting with other drug substances, which had been reasons for other similar pipelines to cease further research.

Non-steatohepatitis, or NASH, is an untapped market with high unmet needs due to the difficulty of novel drug development.

According to GlobalData’s Epidemiology Analysis, the number of NASH patients in seven major medical markets of the US, Japan, Germany, France, the UK, Italy and Spain amounts to 60 million. More than half of these patients were in the US.

LG Chem stressed the importance of the US market for NASH treatment pipelines, underlining the significance of the clinical phase 1 trial of TT-01025 in the US.

By Lim Jeong-yeo (kaylalim@heraldcorp.com)