3 December 2020 - - The US Food and Drug Administration has cleared the Investigational New Drug Application for TT-01025, a novel SSAO/VAP-1 inhibitor for the treatment of non-alcoholic steatohepatitis and other inflammatory diseases, South Korea-based LG Chem's LG Chem Life Sciences division and Chinese clinical-stage biotechnology company TransThera Biosciences Co. Ltd said.

LG Chem will initiate the Phase 1 clinical trial at PPD Las Vegas Clinical Research Unit in Las Vegas, NV, United States to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of TT-01025 in healthy subjects.

The trial is expected to be initiated in 1Q21.

LG Chem reached an exclusive license agreement with TransThera Biosciences on August 17th, 2020 to research, develop, manufacture and commercialize TT-01025 in global region except Greater China and Japan.

TT-01025 is a highly selective oral small molecule inhibitor of Semicarbazide-Sensitive Amine Oxidase/Vascular Adhesion Protein-1 (SSAO/VAP-1) that has shown promising efficacy in pre-clinical investigation in non-alcoholic steatohepatitis.

The inhibition of SSAO/VAP-1 blocks oxidative conversion and leucocyte transmigration during inflammation processes and exhibits therapeutic potential across a range of chronic inflammatory conditions, including NASH.

NASH is a chronic and progressive liver disease characterized by fat accumulation and inflammation in the liver, which can lead to fibrosis and impaired liver function.

The disease can be silent for a long period of time, but once it accelerates, severe damage and liver cirrhosis can occur, which can significantly impact liver function or can even result in liver failure or liver cancer.

There are as yet no globally approved drugs for the indication.

LG Chem Life Sciences is a business division within LG Chem, engaged in the development, manufacturing, as well as commercializing pharmaceutical products globally.

LG Chem Life Sciences seeks to expand and make global presence by focusing on key core therapeutic areas of Immunology, Oncology, and Metabolic Diseases (specifically, diabetes and related metabolic diseases).

To achieve such, its strategy is to actively pursue global collaboration encompassing from asset-centric to strategic investment and collaboration.

TransThera's current portfolio covers therapeutic areas such as oncology, cardiovascular, and inflammatory diseases.