LG Chem Life Sciences and TransThera Biosciences Announce FDA Clearance of IND for TT-01025, a SSAO/VAP-1 Inhibitor

IndustryPRwire --LG Chem Life Sciences, a division of LG Chem, and TransThera Biosciences announced 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.

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.

Dr. Manfred Stapff, President of LG Chem Life Sciences Innovation Center, Cambridge, MA Commented “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, 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.”

Dr. Jennifer Sheng, Vice President of Biology at TransThera Commented “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, 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.

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