LG Chem Life Sciences (“LG Chem”), a division of LG Chem, and TransThera Biosciences Co. Ltd. (“TransThera”), a clinical-stage biotechnology company based in Nanjing, China, announced today that U.S. Food and Drug Administration (FDA) has cleared the Investigational New Drug (IND) application for TT-01025, a novel SSAO/VAP-1 inhibitor for the treatment of non-alcoholic steatohepatitis (NASH) and other inflammatory diseases.

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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 the first quarter of 2021.

“As liver manifestation of a metabolic disorder, NASH is a potentially life threatening condition which increases cardiovascular risk and can lead to cirrhosis with the need for liver transplantation,” said Dr. Manfred Stapff, President of LG Chem Life Sciences Innovation Center, Cambridge, MA. “Since there is no specific treatment for NASH approved so far, we are proud to contribute to the clinical development of TT-01025 to address a significant medical need.”

“The IND clearance for TT-01025 marks an important milestone for its global development. We acknowledge the LG Chem and TransThera teams for their commitment, seamless collaboration and strong team spirit during the IND preparation,” commented Dr. Jennifer Sheng, Vice President of Biology at TransThera. “We look forward to the initiation of Phase 1 trial of TT-01025 in the coming months. We believe that the strong global clinical and commercial capabilities of LG Chem team will accelerate the development of TT-01025 and bring this promising therapy to NASH patients with high unmet medical needs.”

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.

About TT-01025

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 (NASH). 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.

About 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.

About LG Chem Life Sciences

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.

About TransThera Biosciences

TransThera Biosciences is a clinical-stage biotechnology company dedicated to developing innovative therapeutics to target diseases with major unmet medical needs via internal research platform and open innovation. TransThera's current portfolio covers therapeutic areas such as oncology, cardiovascular, and inflammatory diseases. For more information, please visit www.transtherabio.com.

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